Statement of American Academy of Pediatrics
The American Academy of Pediatrics (AAP), a non-profit professional organization of 60,000 primary care
pediatricians, pediatric medical sub-specialists, and pediatric surgical
specialists dedicated to the health, safety, and well-being of infants,
children, adolescents, and young adults, appreciates this opportunity to submit
testimony for the record of this hearing on import safety.
The American Academy of Pediatrics commends the Subcommittees on Trade and Oversight for this effort to pay
long-overdue attention to the safety of imported products. The AAP supports
initiatives to increase staff and funding for regulatory agencies, give them
more tools to police the marketplace, and require manufacturers and sellers of
products to pursue safety more zealously.
The safety of imported
products has special implications for children’s health. In 2006, the United States imported to close $2 trillion worth of goods. A substantial percentage of
these imports were food that was consumed by children and their families and
products for use by or with children. China is the largest producer of
imported children’s toys, responsible for manufacturing 86% of all toys sold in
the United States.
In recent months, public
attention has focused on the safety of children’s products after a wave of
recalls of popular children’s toys by the Consumer Product Safety Commission
(CPSC). Recalls have been issued for toys that violated standards for lead
paint as well as those that posed choking, strangulation, fall, and entrapment
hazards. It is vitally important that the U.S. set and enforce strong
standards to ensure parents that the products used by and with their children
are safe. Manufacturers should be held accountable for ensuring that their
product designs are sound and do not present a foreseeable safety hazard. In
addition, the government should set strict standards for acceptable lead
content in children’s products.
Lead
is Ubiquitous in Our Environment.
Lead is a soft, heavy and malleable metal that occurs naturally in trace amounts
throughout the environment. Due to its abundance and easy workability, it has
been used for thousands of years in plumbing, production of glass and crystal,
and manufacture of ammunition.1 Its toxicity was recognized by the Romans2 and documented during the twentieth century, as its
increasingly widespread use led to unprecedented levels of occupational and
environmental lead poisoning.3 By 1970, science had demonstrated conclusively that
lead could cause both acute poisoning as well as a wide range of long-term
human health consequences.3, 4 Since then, hundreds of studies have shown that the body has no use for
lead, and that a “normal” blood lead level is zero.
Because of its widespread use, lead has been
concentrated in the environment where it poses
a serious threat to children’s health. Furthermore, because it cannot be
identified easily, even when present in high amounts in paint, dust, or dirt,
children can be exposed in their homes and schools and at play without our
knowledge. It is an “invisible” poison.
Low Levels of Lead Can Cause Serious Effects
Damage done by small amounts of lead may be hard to
measure and even harder to understand. Most children who accumulate lead in
their body do not have any physical symptoms, but low lead levels cause a wide array
of negative effects, including cognitive, motor, behavioral, and physical harm.5
There is no “safe” level of lead exposure. The
developing embryo, fetus, and child grow and change rapidly. If, during this
period of change, the fetus or child is exposed to a poison of some kind,
development can be impacted negatively. These “critical windows of exposure”
are specific periods of development during which the embryo or fetus is
undergoing some process (such as the development of arms and legs between days
22 and 36 of pregnancy, when thalidomide damages their development.6, 7)
There are many other examples of this effect, including tobacco smoke and
behavioral effects, and alcohol and fetal alcohol syndrome. The critical
period associated with harm from lead poisoning is brain and nervous system
development, which begins in early pregnancy and continues until at least age 3
years.8
The vulnerability of children to lead poisoning during
development of their brain and nervous system has been amply demonstrated, and
the literature is very consistent. On average, children whose blood lead
levels (BLLs) rise from 10 to 20 mcg/dL lose two to three IQ points. More
recent studies have shown an even greater impact on IQ of BLLs under 10
mcg/dL. Key studies reported a loss of 4 to 7 IQ points in children whose lead
levels rose from 1 mcg/dL to 10 mcg/dL.9, 10
These studies suggest that “low” levels of exposure – meaning BLLs less than 10
mcg/dL – cause proportionately greater harm than higher levels. The effects of
lead on health do not stop once the child reaches age 6 years. A recent study
found that in a group of 7-year old children exposed to lead before the age of
3 years, IQ was more closely related to blood lead at age 7 years than past
blood lead at age 5 or peak blood lead at approximately age 2 years.11
Another important lasting effect of lead exposure is
on behavior, with higher rates of behavioral problems reported in teens and
adults exposed to lead during childhood. Children with elevated lead are more
likely to have problems with attention deficit, reading disabilities, and to
fail to graduate from high school.12
Investigators have identified associations between lead exposure and increased
aggression, commission of crime and antisocial or delinquent behaviors.13-16
Studies have suggested that several nations which began reducing lead exposure
aggressively in the 1970s experienced corresponding decreases in crime rates
two to three decades later.16 Other effects include abnormal
balance, poor eye-hand coordination, longer reaction times, and sleep
disturbances.12, 17, 18
The loss of a few IQ points or a small increase in the
proportion of children with behavioral problems in the population of U.S.
children has marked impacts on educational needs and future potential.19
Since lead exposure is a population-wide risk, even relatively low levels of
exposure can affect large numbers of children. This means that more children
need special education, there are fewer gifted children, and over time, the
average IQ of the entire population falls.
Lead
Poses a Serious Health Hazard to Children At Every Level of Exposure and Every
Stage of Development
Lead is easily absorbed by ingestion or inhalation.
The most common route of exposure of children is through ingestion, usually by
putting hands and other objects in their mouth. Both hand-to-mouth exploration
and playing on floors are typical behaviors for children, especially younger
children. Studies using videos to record oral behaviors of young children
report hand or object in mouth activities 20 or more times per hour.20, 21
If the dirt on their hands or the dust on the floor contains lead, every one of
those activities delivers a dose of lead.
Another significant difference between children and
adults is in the rate of their metabolisms. Children have significantly faster
metabolisms, which means that they breathe faster and ingest proportionately
more food and water.22
This difference means that in similar environments, children are exposed to a
greater extent to contaminants than adults. Since children absorb 5 to 50% of
any lead they ingest (compared to adults, who absorb 10-15%),23 they are at high risk of lead poisoning every time they are exposed.
Once lead enters the body it remains there for years.
Lead is similar to calcium from the elemental perspective. This means that our
bodies “see” lead as calcium, absorb it into blood and then store it in bone. These stores of lead can be released years
later, when bone changes occur or demands on calcium stores are made.24 Another consequence of storing lead in bone is that
exposures separated by months or years have an additive effect on the body’s
burden of lead and can exert effects over decades. Acquisition of lead in the
body even in small amounts (i.e., amounts that result in BLLs less than 10
mcg/dL) contribute to this accumulation of lead. This means that commonly
encountered blood lead concentrations have lasting negative effects.
Another consequence of this accumulation of lead in
bone is the exposure of the fetus to lead by the mothers. Women exposed to
lead during childhood may have significant stores of lead in their bones. If
they do not consume adequate calcium during pregnancy, their bones release
calcium as the fetus grows. As the calcium is released, lead is released as
well. This lead can be transferred to the fetus – exposing the fetus’
developing brain and nervous system at a critical time. Fetal exposure from
this route has been demonstrated to cause measurable decreases in IQ.25
Sources of
Children’s Exposure to Lead
The most common source of lead exposure today is lead
paint, found in older housing stock. As paint wears off, it contaminates the
dust that clings to surfaces, toys and the fingers of children. Other sources
of lead exposure include contaminated soil, traditional or folk medicines, and
certain types of dishes. In recent years, however, parents have found a new
source of anxiety regarding lead exposure: children’s toys and other products,
particularly those imported from China.
These concerns are justified. Since July 2006, the CPSC has issued at least 11
recalls affecting more than 6.7 million units of children’s toy jewelry due to
excessive lead content. Since 1998, CPSC has issued at least 29 recalls
involving 157,962,000 pieces of toy jewelry due to high lead levels. Other
products recalled during that time due to lead contamination include game
pieces, candles, sidewalk chalk, and art kits. Consumers are acutely aware of
recent recalls of popular toys found to contain lead paint, including Thomas
the Tank Engine, Mattel’s Barbie, and Fisher-Price’s Dora the Explorer toys.
The risk of harm to children from these toys is real: in 2006, a 4-year-old Minnesota boy died after ingesting
a small Reebok shoe charm that was later found to be 99.1% lead.26 The charm he ingested dissolved in his stomach, releasing the lead into
his bloodstream.
Lead
Must Be Removed from Toys and Other Children’s Products
The American Academy of Pediatrics has consistently
urged the Consumer Product Safety Commission (CPSC), the Environmental
Protection Agency (EPA), and other agencies to take aggressive, proactive steps
to minimize children’s exposure to lead. The
addition of lead to jewelry or toys is not in any way central or even necessary
to the function or purpose of the product. For example, manufacturers add lead
to jewelry to give it more weight or heft, rather than using a more expensive
but safer metal. None of these factors represent a compelling rationale for
including a poisonous substance in a product specifically designed for use by
children.
The range of products covered by a ban on lead content
must also be considered carefully. “Children’s product” must be defined
broadly enough to cover the full range of items capable of causing a serious
hazards – not just toys or “toy” jewelry but also durable products such as
furniture (cribs, strollers, high chairs, etc.) and products meant for the care
of children (bath seats, gates, etc.). One of the first pediatric deaths
attributed to lead paint was a child who chewed on the railing of his crib – in
1913.4
Finally, legislation should cover products meant or
designed for use by or with children at least up through the age of 12.
Children are susceptible to neurological damage from lead exposure throughout
the development of their brain and nervous system. Their long “shelf life,” or
the period of time over which they can be exposed to and accumulate lead in
their bodies, means that every exposure should be eliminated or minimized to
prevent future harms. Finally, toys meant for older children often find their
way into the hands of younger siblings and other small children, posing a
hazard to these children outside the object’s target audience.
Federal Lead Standards
Federal agencies use a variety of standards for
unacceptable lead content. This issue is complicated by the fact that lead
uptake varies depending upon the route of exposure (ingestion, inhalation, skin
contact, etc.) In considering existing guidelines, it is critical to bear in
mind that many were set before research demonstrated the harmful effects of
lead at low levels. There is no known safe level of lead exposure; as a
result, exposure to lead below these levels should not be considered “safe.”
- In
1978, the Consumer Product Safety Commission banned the manufacture of
paint containing more than 0.06% lead by weight on interior and exterior
residential surfaces, toys, and furniture.
- Based
on that standard for lead paint, the CPSC’s current voluntary standard
prohibits toy jewelry to contain more than 0.06% lead by weight. The
standard further requires manufacturers to test for the “accessibility” of
lead, although surface accessibility may be irrelevant if an item is small
enough to be ingested.
- The
EPA requires water provided by public utilities to contain no more than 15
parts per billion of lead. The 1986 Safe Drinking Water Act Amendments
banned the use of lead in public drinking water distribution systems and
limited the lead content of brass used for plumbing to 8%.
- The
EPA set guidelines for lead contamination of dust, limiting levels called
“safe” to below 40 mcg/ft2 for floors.27 It is important to note that this is not a health-based standard;
an estimated 20% of children exposed to floor dust lead levels at 40
mcg/ft2 will have a blood lead level above 10 mcg/dL.28
- In
response to reports of lead contamination in candies likely to be consumed
frequently by small children, the Food and Drug Administration (FDA) set a
maximum lead level of 0.1 parts per million (ppm). FDA has set different
levels for other products; for example, dairy product solids may contain
lead at no more than 0.5 ppm.29
- The
FDA recommends a limit on children’s lead intake in food to no more than 6
mcg/day. It is important to note that this is not a health-based standard;
this limit is roughly equivalent to the amount of lead that would be
expected to lower IQ by 1 point.
- FDA
regulates lead content in cosmetics; for example, the colorant manganese
violet may contain lead at no more than 20 ppm.30
- Airborne
lead is regulated by EPA as a “criteria pollutant” under the Clean Air
Act. The National Ambient
Air Quality Standard for lead is 1.5 mcg/m3, maximum arithmetic
mean averaged over a calendar quarter.
- Both
the National Institute for Occupational Safety and Health and the
Occupational Safety and Health Administration set permissible limits for
lead exposure in the workplace, but these guidelines are designed for
adults and not appropriate for children.
Recommendations
To protect the
health of our nation’s children, the CPSC must be given the tools it needs to
fulfill its mission. In particular, nonessential uses of lead, especially in
products to which children may be exposed, must be prohibited. The American Academy of Pediatrics recommends the following:
- The
CPSC should require all products intended for use by or in connection with
children to contain no more than trace amounts of lead.
- The
Academy recommends defining a “trace” amount of lead as no more than 40
ppm, which is the upper range of lead in uncontaminated soil.31 This standard would recognize that contamination with minute
amounts of lead in the environment may occur but can be minimized through
good manufacturing practices.
- “Children’s
product” should be defined in such a way as to ensure it will cover the
wide range of products used by or for children. This standard should cover
toys intended for use by or with children under the age of 12 years.
- The
limit on lead content must apply to all components of the item or
jewelry or other small parts that could be swallowed, not just the surface
covering.
- Legislation
or regulations should limit the overall lead content of an item, rather
than only limiting lead content of its components. A single product may
contain numerous components that could cumulatively contain a dangerous
level of lead.
- The
CPSC must be funded adequately. The President requested a budget
of $63.2 million for CPSC in Fiscal Year 2008, which would require the
agency to cut an additional 19 employees. This budget is insufficient to
even allow the agency to continue current programs, much less expand its
efforts. At its founding, the CPSC budget was $39 million. If the budget
had kept pace with inflation, it would be $138.2 million today, more than
double its requested allocation.
- An appropriately qualified CPSC chair must be nominated and approved
in a timely fashion. The CPSC has been without a voting quorum of
commissioners since January 2007, meaning it cannot take many regulatory,
enforcement and other actions. The President’s recent nominee to chair the
commission withdrew from consideration after a public outcry regarding his
qualifications.
- The authority of the agency to issue mandatory recalls and
provide full information to consumers must be strengthened.
Conclusion
Our government
can and must do more to ensure the safety of imported products, particularly
those intended for use by or with children. A strong standard for lead content
must also be set, since there is no known “safe” level of lead for children.32, 33 No study has determined a blood lead level that does not impair child cognition. Since any measurable
lead level causes lasting harm, prevention of exposure is the only treatment.34 Lead exposure is an important, unnecessary, and preventable poisoning.
The American Academy of Pediatrics appreciates this opportunity to submit testimony for the
record of this hearing on import safety. If the AAP may be of further
assistance, please contact our Washington, D.C. office.
References.
1. Chemistry:
WebElements Periodic Table. http://www.webelements.com/webelements/elements/text/Pb/key.html.
Accessed March 31, 2004.
2. Lead Poisoning
and Rome. http://itsa.ucsf.edu/~snlrc/encyclopaedia_romana/wine/leadpoisoning.html.
Accessed March 31,.
3. Markowitz G,
Rosner D. "Cater to the children": the role of the lead industry in a
public health tragedy, 1900-1955. Am J Public Health. 2000;90(1):36-46.
4. Warren C. Brush
With Death: A Social History of Lead Poisoning. Baltimore, MD: Johns
Hopkins University Press; 2000.
5. Bellinger D.
Lead. Pediatrics. 2004;113(4 (Supplement)):1016-1022.
6. Brent R.
Environmental causes of human congenital malformations: the pediatrician's role
in dealing with these complex clinical problems caused by a multiplicity of
environmental and genetic factors. Pediatrics. 2004;113(4
(Supplement)):957-968.
7. Sadler TW. Langman's
Medical Embryology. 6th ed. Baltimore, MD: Williams & Wilkins; 1990.
8. Mendola P,
Selevan SG, Gutter S, Rice D. Environmental factors associated with a spectrum
of neurodevelopmental deficits. Ment Retard Dev Disabil Res Rev. 2002;8(3):188-197.
9. Canfield RL,
Henderson CR, Jr., Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP. Intellectual
impairment in children with blood lead concentrations below 10 microg per
deciliter. N Engl J Med. 2003;348(16):1517-1526.
10. Lanphear BP,
Hornung R, Khoury J, et al. Low-level environmental lead exposure and
children's intellectual function: an international pooled analysis. Environ
Health Perspect. Jul 2005;113(7):894-899.
11. Chen A, Dietrich
KN, Ware JH, Radcliffe J, Rogan WJ. IQ and blood lead from 2 to 7 years of age:
are the effects in older children the residual of high blood lead
concentrations in 2-year-olds? Environ Health Perspect. 2005;113(5):597-601.
12. Centers for
Disease Control and Prevention. Managing Elevated Blood Lead Levels Among
Young Children: Recommendations from the Advisory Committee on Childhood Lead
Poisoning Prevention. Atlanta, GA: Centers for Disease Control and
Prevention.; 2002.
13. Dietrich KN, Ris
MD, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and juvenile
delinquency. Neurotoxicol Teratol. Nov-Dec 2001;23(6):511-518.
14. Ris MD, Dietrich
KN, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and
neuropsychological outcome in adolescence. J Int Neuropsychol Soc. Feb
2004:261-270.
15. Burns JM,
Baghurst PA, Sawyer MG, McMichael AJ, Tong SL. Lifetime low-level exposure to
environmental lead and children's emotional and behavioral development at ages
11-13 years. The Port Pirie Cohort Study. Am J Epidemiol. Apr 15
1999;149(8):740-749.
16. Nevin R.
Understanding international crime trends: the legacy of preschool lead
exposure. Environ Res. 2007;104(3):315-336.
17. Bhattacharya A,
Shukla R, Dietrich KN, Bornschein RL. Effect of early lead exposure on the
maturation of children's postural balance: a longitudinal study. Neurotoxicol
Teratol. 2006;28(3):376-385.
18. Chiodo LM,
Covington C, Sokol RJ, et al. Blood lead levels and specific attention effects
in young children. Neurotoxicol Teratol. Apr 21 2007.
19. Bellinger DC.
What is an adverse effect? A possible resolution of clinical and
epidemiological perspectives on neurobehavioral toxicity. Environ Res. 2004;95(3):394-405.
20. Reed KJ, Jimenez
M, Freeman NC, Lioy PJ. Quantification of children's hand and mouthing
activities through a videotaping methodology. J Expo Anal Environ Epidemiol.
1999;9(5):513-520.
21. Ko S, Schaefer
PD, Vicario CM, Binns HJ. Relationships of video assessments of touching and
mouthing behaviors during outdoor play in urban residential yards to parental
perceptions of child behaviors and blood lead levels. J Expo Sci Environ
Epidemiol. 2007;17(1):47-57.
22. Plunkett LM TD,
Rodricks JV,. Differences between adults and children affecting exposure
assessment. In: Guzelian PS HC, Olin SS,, ed. Similarities and Differences
Between Children and Adults: Implications for Risk Assessment. Washington,
DC: ILSI Press; 1992:79-94.
23. United State
Environmental Protection Agency. Review of the National Ambient Air Quality
Standards for Lead: Exposure Analysis Methodology and Validation.
Washington, DC: Air Quality Management Division, Office of Air Quality Planning
and Standards, US Environmental Protection Agency.; 1989.
24. O'Flaherty EJ. A
physiologically based kinetic model for lead in children and adults. Environ
Health Perspect. 1998;106 Suppl 6:1495-1503.
25. Schnaas L,
Rothenberg SJ, Flores MF, et al. Reduced intellectual development in children
with prenatal lead exposure. Environ Health Perspect. 2006;114(5):791-797.
26. Centers for
Disease Control and Prevention. Death of a child after ingestion of a metallic
charm--Minnesota, 2006. MMWR. 2006;55(12):340-341.
27. Federal Register.
Part III, Environmental Protection Agency. Lead; Identification of Dangerous
Levels of Lead: Final Rule. 2001;66:1206-1240.
28. Lanphear BP,
Weitzman M, Winter NL, et al. Lead-contaminated house dust and urban children's
blood lead levels. Am J Public Health. 1996;86(10):1416-1421.
29. Food and Drug
Administration. GRAS affirmation petition GRP 1G0371. http://www.cfsan.fda.gov/~rdb/opa-g037.html.
30. US Food and Drug
Administration. 21CFR73.2775. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=73.2775.
31. Friedland A,
Johnson A. Lead distribution and fluxes in a high-elevation forest in northern
Vermont. J Environ Qual. 1985;14:332-336.
32. American Academy
of Pediatrics Committee on Environmental Health. Lead exposure in children:
prevention, detection, and management. Pediatrics. 2005;116(4):1036-1046.
33. Centers for
Disease Control and Prevention. Preventing Lead Poisoning in Young Children.
Atlanta: CDC; 2005.
34. Centers for
Disease Control and Prevention. Preventing Lead Exposure in Young Children:
A Housing-Based Approach to Primary Prevention of Lead Poisoning. Atlanta:
CDC; 2004.
|