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Children's Health Protection

Regulations


EPA is committed to considering risks to children in developing standards to protect human health and the environment. This commitment is reflected in:

  • Rulemaking Guidance
  • Transparency in Regulatory Development
  • Development of Rules and Actions
  • You will need Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more.

    Rulemaking Guidance

    Agency action development guidance entitled Guide to Considering Children's Health When Developing EPA Actions: Implementing Executive Order 13045 and EPA's Policy on Evaluating Health Risks to Children (PDF) (42 pp, 728K) is available. This Guide is designed to help Agency staff involved in developing regulatory actions determine whether Executive Order 13045 "Protection of Children from Environmental Health Risks and Safety Risks" and/or EPA's policy on evaluating health risks to children (Children's Health Policy) applies to an Agency action and, if so, how to implement the Executive Order and/or EPA's Policy. EO 13045 requires that 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." In addition, the Children's Health Policy requires 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." Since the issuance of the first EPA's Rule Writer's Guide to Executive Order 13045 in 1998, EPA has published several guidance documents relating to risk assessment, regulatory policy and action development. The Guide has been revised to reflect these developments. In addition, this Guide more clearly integrates EPA's Policy on Children's Health with the Action Development Process, and provides an updated listing of additional guidance documents.

    Guidelines for Preparing Analytic Blueprints. EPA typically prepares an Analytic Blueprint when developing rules, policies, and other actions. An Analytic Blueprint describes the Agency's plans for data collection and analyses to support developing the action. To ensure that children's health is properly considered, the Guidelines identify the need for analyses related to children's health including determining whether the action may disproportionately affect children, assessing risks to children, and analyzing the distribution of the costs and benefits. For more information on how EPA writes regulations and the EPA regulatory management process, see www.epa.gov/lawsregs/brochure/index.html and www.epa.gov/aboutepa/opei.html#ORPM .

    Children's Health Valuation Handbook (October 2003). EPA developed the Children's Health Evaluation Handbook as a reference tool for analysts conducting economic analyses of EPA regulations and policies that may affect risks to children's health. This handbook focuses on valuing changes in risks to children's health caused by environmental improvement or degradation. It addresses incorporating children's health considerations in efficiency assessments and distributional analyses.

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    Transparency in Regulatory Development

    On April 14, 2008, EPA announced that it is making Federal environmental regulation more transparent by providing online information as soon as the agency begins the development of a new rule.

    EPA is now using Action Initiation Lists (AILs) to notify the public about new rules and other regulatory actions. The AILs provide summaries, agency contacts, and other information about the rules EPA has approved for development. AILs will be posted on the EPA Web site at roughly the end of each month; each will describe those actions that were approved for commencement during the given month. Formerly, the public had to wait for EPA's Semiannual Regulatory Agenda, which is updated only every six months, to learn about new regulatory actions. Learn more about EPA's Action Initiation Lists.

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    Development of Rules and Actions

    Background

    Regulatory Actions are one of the major ways that EPA can protect children from environmental health hazards. Executive Order 13045, signed in 1997 by President Clinton, directs the EPA and other federal agencies to “make it a high priority to identify and assess environmental health risks and safety risks that may disproportionately affect children” and “ensure that its policies, programs, activities, and standards address disproportionate risks to children that result from environmental health risks or safety risks”. Therefore, under this directive, the EPA considers potential impacts for adverse effects on children in its rulemakings. Children have many unique susceptibilities to environmental contaminants. Because of differences in breathing patterns, food and water consumption, activity patterns, and inherent physiological and developmental differences depending on life stage, children may experience greater health effects from environmental risks than adults.

    Breathing: Children breathe more than adults (per pound body weight and surface area of the respiratory tract). For example, a three month old infant breathes about 35 times more air than adults. Additionally, substantial lung development takes place after birth, primarily through adolescence.

    Eating and drinking: Children consume more food and water than adults (per pound body weight). Young children often have higher intakes of certain food categories, and are more likely to have less variation in their diets. For example, infants consume approximately ten times more apples than adults. Breast milk is another important exposure pathway that is unique to infants and young children. Additionally, infants may consume a large volume of drinking water through infant formula that is reconstituted with tap water.

    Activity patterns: Children are more likely to spend time outdoors than adults and are therefore more likely to be exposed to certain outdoor pollutants. Also, infants and toddlers are disproportionately exposed to many contaminants because they crawl and play on or near the floor or ground. Contaminants, such as lead and pesticides, often settle in floor dust where children can be exposed to them. Infants and toddlers also pass through a developmental stage characterized by oral exploration. They often touch or handle objects and then place their fingers or the objects into their mouths. As a result of this mouthing behavior, children can consume much higher levels of contaminated dirt and dust than adults.

    Physiological differences: There are many physiological differences that can affect how environmental contaminants are absorbed, distributed, metabolized, and excreted from a child’s body. For example, children’s skin is more permeable and easily damaged. Children also retain ingested substances longer in the stomach and the small intestines, they have a more permeable blood-brain barrier, and they have greater cerebral blood flow.

    Developmental differences: A child undergoes critical stages of development for each organ and system, where there is the potential for chemical exposures to disrupt growth patterns. For example, the nervous, reproductive and metabolic systems develop throughout childhood, and the respiratory system is fully developed between two and ten years of age, with growth continuing through adulthood.

    The Office of Children’s Health Protection’s (OCHP) Regulatory Support and Science Policy Division (RSSPD) works to address the potential for unique exposures, hazards, health effects, and health risks in children during the development of agency regulations and policies. This page provides examples of some of the important regulations EPA is currently working on that are of interest to children’s health. A link for more information is included after each description. (updated 8/16/2011)


    Air Regulations

    Review of the National Ambient Air Quality Standards for Ozone
    Research has linked ozone exposure with a variety of health effects, including numerous respiratory symptoms in children. Children, especially asthmatic children, are highly susceptible to ozone. Children are more likely than adults to be active outside in the summer, when ozone levels are highest. Also, children are susceptible to ozone air pollution because they breathe proportionally more air than adults, their respiratory systems are still developing, and they have greater asthma prevalence than adults.
    http://www.e pa.gov/ttn/naaqs/standards/ozone/s_o3_index.html

    Review of the National Ambient Air Quality Standards for Lead
    Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems. Lead that is emitted into the air can be inhaled or, after it settles out of the air, can be ingested. Ingestion of lead that has settled onto surfaces is the main route of exposure to lead originally released into the air. Children are most vulnerable to the damaging effects of lead because they are more likely to ingest lead due to hand-to-mouth activity and their bodies are developing rapidly.
    http://www.epa. gov/ttn/naaqs/standards/pb/s_pb_index.html

    Review of the National Ambient Air Quality Standards for Nitrogen Dioxide
    Research has shown that exposures to nitrogen dioxide are linked with a variety of respiratory effects, including respiratory symptoms in children, particularly those with asthma. Infants and children may be more susceptible than adults because their lungs are still developing, they have greater prevalence of asthma, they have higher breathing rates per body weight, and participate in higher exposure activities, including outdoor play.
    http://www.ep a.gov/ttn/naaqs/standards/nox/s_nox_index.html

    Endangerment Finding for Lead Emissions from Piston-Engine Aircraft Using Leaded Aviation Gasoline
    Although removed from automobile gasoline by 1996, lead is still used in aviation gasoline for piston-engine-powered airplanes and currently accounts for approximately half the lead emitted to air annually. EPA is evaluating lead emissions, ambient concentrations and potential exposure to lead from the use of leaded aviation gasoline in piston-engine powered aircraft. Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems.
    http://www.ep a.gov/otaq/regs/nonroad/aviation/420f10013.pdf

    Control of Air Pollution from New Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards
    Emissions from motor vehicles contribute to both local and regional air pollution that may be harmful to children such as ozone, nitrogen dioxide, and particulate matter. Children are more susceptible to exposure to these emissions because they breathe proportionally more than adults, their lungs are developing, and on average they participate in higher exposure activities, including outdoor play. Research has shown that children who live or go to school near busy roadways may be more likely to develop asthma, in addition to experiencing greater respiratory symptoms.
    http://www.epa.gov/otaq/tier3.htm

    Water Regulations

    National Primary Drinking Water Regulations for Lead and Copper: Regulatory Revisions
    Children can be exposed to lead and copper via drinking water, as the metals leach from plumbing materials. Short-term exposure to copper may cause health problems such as gastrointestinal distress and long-term exposure may lead to liver or kidney damage. Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems. Drinking water contaminants such as lead and copper are a concern for children because they absorb lead and copper at higher rates than adults, and they consume more water than adults, especially infants whose formula is made with tap water.
    http://water.e pa.gov/lawsregs/rulesregs/sdwa/lcr/index.cfm

    Drinking Water: Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List
    The Safe Drinking Water Act requires the consideration of sensitive lifestages, like children, in the regulatory determination process for national drinking water standards. Drinking water contaminants may have adverse health effects associated with exposures for a specific developmental group or period of sensitivity. In addition, the 2005 Cancer Guidelines require consideration related to increased risks from mutagenic carcinogens due to early childhood exposure.
    ht tp://yosemite.epa.gov/opei/rulegate.nsf/byRIN/2040-AF15?opendocument

    National Primary Drinking Water Regulations: Regulation of Perchlorate
    EPA has initiated the process to develop a national primary drinking water regulation (NPDWR) for perchlorate. An NPDWR will establish a legal limit on the level of perchlorate in drinking water. The legal limit will reflect both the level that protects human health and the level that water systems can achieve using the best available technology. The National Academy of Sciences identified "the fetuses of pregnant women who might have hypothyroidism or iodide deficiency" as "most sensitive" but also identified infants and developing children as additional “sensitive” lifestages. Infants and young children have greater exposure to contaminants in food and water because of greater consumption of food and water on a per unit body weight basis, especially infants whose formula is made with tap water. Therefore, these lifestages may be the most vulnerable when their relative exposure is considered.
    http: //water.epa.gov/drink/contaminants/unregulated/perchlorate.cfm

    National Primary Drinking Water Regulations: Group Regulations of Carcinogenic Volatile Organic Compounds (VOCs)
    Early-life exposure to carcinogenic volatile organic compounds (VOCs) may increase the risk of developing cancer later in life. Carcinogenic VOCs in drinking water are a particular concern for children because they consume more water than adults per unit body weight, especially infants whose formula is reconstituted with tap water. Exposures to certain carcinogenic VOCs may also lead to other adverse noncancer health effects such as reproductive and developmental effects.
    http://yosemite .epa.gov/opei/rulegate.nsf/byRIN/2040-AF29

    Chemical Safety Regulations

    Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings
    Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems. Common renovation activities on the exterior of public and commercial buildings may result in the deposition of lead dust and paint chips on nearby properties such as housing and day care centers. This may result in lead-based paint dust exposure to children both outside and inside such facilities. Lead dust and paint chips may be accidentally ingested via common childhood behaviors such as hand-to-mouth activities.
    http://yosemite .epa.gov/opei/RuleGate.nsf/byRIN/2070-AJ56

    Lead Wheel Weights; Regulatory Investigation
    Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems. Lead wheel weights are sometimes lost in the environment where children can be exposed.
    http://yosemite .epa.gov/opei/rulegate.nsf/byRIN/2070-AJ64

    Lead; Residential Lead Dust Hazard Standards (TSCA Sec 403)
    Lead was used for many years in products found in and around our homes, and is still found in some products. Lead harms the nervous systems of children and infants, causing effects on IQ, learning abilities, and contributing to behavioral problems. Lead exposure also impairs normal growth, and affects the immune and other systems. Lead exposure can be increased because babies and young children often put their hands and other objects that can have lead dust on them in their mouths. Also, children’s growing bodies absorb more lead than adult bodies do, and their brains and nervous systems are more sensitive to the damaging effects of lead.
    http://www2.epa.gov/lead/hazard-standards-lead-paint-dust-and-soil-ts ca-section-403

    Formaldehyde Emissions from Pressed Wood Products
    Children exposed to formaldehyde may experience sensory irritation, the onset of asthma, and develop some types of cancer, depending on concentration and duration of exposure. Children are susceptible to formaldehyde emissions because they breathe more air than adults, and their respiratory systems are still developing.
    http://www.epa.g ov/oppt/chemtest/formaldehyde/index.html

    Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations
    Exposure to PCBs during pregnancy and early prenatal life is of great concern because the effects of PCBs on sensitive immature tissues, organs, and systems, can have serious long-lasting consequences. PCBs have been linked to various health outcomes such as decreased gestational age at birth, lower birth weight, depressed immune responses, impaired mental development, and growth retardation. Nursing infants may have especially high exposures as PCBs are lipophilic substances, and can accumulate in breast milk.
    http://yosemite .epa.gov/opei/rulegate.nsf/byRIN/2070-AJ38

    Pesticides; Agricultural Worker Protection Standard Revisions
    The Agency is considering revisions to this rule to reduce potential pesticide exposures and improve health protections for agricultural workers and for children who live, play or work on or near covered agricultural establishments.
    http://www.epa.gov/oecaagct/twor.ht ml

    Pesticides; Certification and Training Revision
    The Agency is considering changes to the federal regulation governing the certification of pesticide applicators using restricted use products. The proposals are intended to improve the competency of such pesticide applicators. More competent applicators will be better able to protect themselves, the public, and the environment from pesticide risks. The proposals are also intended to better protect children through establishing a minimum age for certified applicators to protect adolescents, and establishing requirements for additional training designed to protect families from pesticide exposure.
    http://www .epa.gov/oppfead1/safety/applicators/applicators.htm

    TSCA Section 6 Rule for Long-Chain Perfluorinated Chemicals (PFCs)
    Long-chain PFCs are prevalent and persistent in the environment; they also bioaccumulate and can remain in people for years. Long-chain PFCs are a concern for children because studies in laboratory animals have demonstrated developmental toxicity, including neonatal mortality in laboratory animals. In addition, biomonitoring studies have found PFCs in cord blood and breast milk, and have reported that children have higher levels of some PFCs compared to adults.
    http://yo semite.epa.gov/opei/rulegate.nsf/(LookupRIN)/2070-AJ72

    To address similar concerns, EPA has proposed a related Significant New Use Rule (SNUR) for Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substances. More information is available here: http://www.epa.gov/o ppt/pfoa/pubs/pfas.html#proposed.

    Registration Review for Chlorpyrifos
    Chlorpyrifos is an organophosphate (OP) pesticide with registered uses primarily on food and feed crops. Several of the limited non-agricultural and non-residential uses are for golf course turf, wood products, greenhouse and nursery production, and as an adult mosquitocide. In 2000, all residential uses of chlorpyrifos were cancelled, except ant and roach bait station products in child resistant packaging. Chlorpyrifos is currently undergoing registration review, which is EPA’s process pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), where each registered pesticide is reviewed every 15 years to determine whether it continues to meet the FIFRA standard for registration. There is evidence that exposure to OP pesticides can affect the developing nervous system. Prenatal exposure in pregnant women and early postnatal exposure are particularly of concern as this is a vulnerable period for the developing nervous system. Behavioral patterns of young children, such as playing on the floor and putting objects in their mouth, also increase the chance of dermal or oral exposure.
    Registration Review for Chlorpyrifos:
    http://w ww.regulations.gov/#!docketDetail;D=EPA-HQ-OPP-2008-0850

    Significant New Use Rule for Toluene Diisocyanates (TDI) and Related Compounds
    Inhalation exposure to two diisocyanates, methylene diphenyl diisocyanate (MDI) and toluene diisocyanate (TDI), has been documented to result in asthma, lung damage, and in severe cases, fatal reactions. Dermal exposures to either of these chemicals also results in asthma. Worker exposures are already subject to protective controls in occupational settings. However, products that contain uncured MDI or TDI and its related polyisocyanates (e.g., spray-applied foam sealants, adhesives, and coatings) are used in homes and schools where children may be exposed. Children breathe in more air proportionally than adults, and they spend more time close to the ground, increasing inhalation and dermal exposure.
    Methylene Diphenyl Diisocyanate Action Plan:
    http: //www.epa.gov/oppt/existingchemicals/pubs/actionplans/mdi.html
    Toluene Diisocyanate Action Plan:
    http: //www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.html

    Other Actions

    Revisions to Human Test Subjects Rule
    EPA is finalizing narrowly-tailored amendments to the portions of its 2006 rule for the protection of human subjects of research (http://www.epa.gov/op pfead1/guidance/human-test.htm) applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. They also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The 2006 rule prohibits any EPA-sponsored research involving intentional exposure of pregnant or nursing women or children to any environmental substance.
    http://www.epa.gov/op pfead1/guidance/cr-require.htm

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