Protecting Children from Overexposure to Lead in Candy and Protecting Children by Lowering the Blood “Level Of Concern” Standard

  • Date: Dec 14 2005
  • Policy Number: 20057

Key Words: Child Health And Development, Immigrants, Lead Poisioning

The American Public Health Association:
Recognizing that in April 2004, the Orange County Register in an investigative report, published for the first time information that the state of California had been testing for lead in candies for decades but had not informed the public about the high lead levels in many candies, candy wrappers and seasonings (sold as a snack item and consumed as candy) imported from Mexico, the Philippines and other countries,1 and
Recognizing, as a result of the April 2004, Orange County Register report, various state and county environmental health practitioners, and congressional legislators have become aware of the inconsistently high lead level found in imported candies (and their wrappers).1,2 Childhood lead poisoning has previously been reported as being associated with candy from Mexico,3,4 and 
Knowing that a significant and unnecessary health risk to Latino and other children exists when they ingest many types of imported candies containing high lead levels (both salt- and sugar-based). These candies are sold in United States grocery stores, in ethnic markets, at swap meets, and from street vendor stalls and carts. Many have been found to have high levels of lead,1 and
Noting the United States Food and Drug Administration's lead enforcement standards on candies, made in Mexico, the Philippines and other countries and imported into the United States, fail to adequately protect Latino and other children who consume these candies, and
Recognizing the FDA has set no enforcement standards on imported salt-based candies and that the FDA treats these salt-based candies like seasonings,2 and
Further, recognizing that these salt-based products are stored and marketed in containers that are attractive to children and are consumed as candies. Latino and other children can consume one or more containers of these candies per day,2 and
Noting that independent laboratory test results, on samples of these salt-based candies taken from two different agencies in two different states, revealed a large variation in the lead content from one salt-based candy container to another. However, both agencies' test results had the same mean average of 15 micrograms of lead per salt-based container,2 and
Understanding that at 15 micrograms of lead, in an imported salt-based candy container, it would take a young child's ingesting only four of these containers per day to increase the child's blood lead level by 10 micrograms per deciliter,5 and
Noting the FDA recommends a 6 micrograms per day tolerable limit for dietary intake of lead for children age 6 years or younger to prevent the more subtle adverse neurological and behavioral effects of lead exposure,5 and
Realizing that consuming the contents of one of these imported salt-based candy containers in a day, containing 15 micrograms of lead, exceeds the FDA's maximum recommended daily dietary lead intake standard by 150 percent, and
Noting, in regards to sugar-based candy, the FDA initially stated it would, "consider action against candy products that exceed 0.5 ppm lead"; however, the FDA subsequently revised this standard stating, "it may also consider action against candy products containing 0.5 ppm or less lead, when the amount of lead per serving is 10 micrograms or more",6 and
Understanding the FDA's enforcement level of 10 micrograms of lead per single serving of sugar-based candy exceeds the FDA's maximum recommended daily dietary lead intake standard by 67 percent, and
Noting the National Academy of Sciences' Food Chemicals Codex (FCC) specification for lead in sucrose (sugar) is 0.1 ppm.7 Therefore, the standard for lead in all candy should not exceed the standard for lead in sugar, since candy, unlike sugar, is not normally diluted with other food products before being ingested, and
Noting that in 2004, the FDA issued a warning stating, "The Food and Drug Administration (FDA) is aware of the problem associated with lead contamination of some Mexican candy products being sold in the United States and is advising parents, care providers and other responsible individuals that it would be prudent to not allow children to eat these products at this time",8 and
Recognizing this FDA warning is insufficient to protect children's health because it does not adequately prevent the consumption of these candies, either because parents and child care providers are unaware of the existence of this warning statement or because they elect not to comply with the FDA's warning, and 
Realizing that in August of 2004, Lucas®, a subsidiary of Mars Inc., announced a voluntary withdrawal of these imported salt-based candies, which are labeled as seasonings.9 However, these salt-based candies were still readily available for sale on store shelves in the United States months after the candy company announced its voluntary withdrawal,10 and
Understanding the FDA should set lead enforcement standards on all salt-based candies, rather than rely on the industry to voluntarily withdraw these lead tainted candies, and
Realizing the U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction, including lead contaminated candy wrappers,11 and
Knowing children will be exposed to lead from licking or eating lead contaminated candy wrappers, the U.S. Consumer Product Safety Commission sent letters to candy producers in Mexico and to candy importers in the United States informing them to halt future imports of candy until they could ensure that the candy wrappers did not contain lead or use lead containing ink, 39,12,13 and
Realizing that legislation has been introduced directing the U.S. Consumer Product Safety Commission to adopt regulations, which would ban all consumer products that contain more than a trace amount of lead, including candy wrappers to which children under age 6 are exposed.14 Knowing that preventing the exposure to lead from all sources, including consumer products, is essential to protect children from the toxic effects of lead, and
Understanding that while lead is often noted for its neurotoxicity, an elevated lead level is also a risk factor for other health problems, such as aggressive behavior, school and social failure, hearing loss, hypertension, cardiovascular disease, renal disease, and dental caries,15 and
Understanding that lead and lead compounds have been recently listed as, "reasonably anticipated to be human carcinogens,"16 and

Recognizing several longitudinal studies, of lead exposure and cognitive function, have found neurodevelopmental delays and reduction in IQ at even low levels of lead exposure in children.15,17-23 This neurological damage caused by lead appears to be irreversible,15,24 and
Understanding research supports the conclusion that reduction of IQ in children results when blood levels are below 10 micrograms per deciliter. The evidence clearly demonstrates the highest rates of IQ loss occur at low blood lead levels,15,23,-2 9 and
Recognizing that one recent study's "best estimate" of IQ losses in children is 7.4 IQ points, as the lifetime blood lead levels rise from 1 to 10 micrograms per deciliter.15 However, the U.S. Centers for Disease Control and Prevention's "blood lead level of concern," is set at a blood lead level of 10 micrograms per deciliter or greater,30 and
Recognizing a recent international pooled analysis of data, from previous studies on the effects of lead on children's intellectual function, showed an observed decline of 6.2 IQ points for an increase in blood lead levels from < 1 to 10 micrograms per deciliter. This study also concluded that blood lead levels in children < 7.5 micrograms per deciliter is associated with intellectual deficits,29 and
Understanding recent studies suggest there may be no toxic threshold limit for the adverse consequences of lead exposure.15,29,31 Therefore, the current CDC's 
"blood lead level of concern" of 10 micrograms per deciliter should not be interpreted as a threshold for toxicity,31 and
Understanding that even though the CDC Childhood Lead Poisoning Prevention Program recognized that elevated blood lead levels below the CDC's "blood lead level of concern" of 10 micrograms per deciliter can cause adverse health effects, it elected not to lower its "blood lead level of concern",23,32 and
Recognizing the CDC's "blood lead level of concern" is misleading because it is actually an "action level." It is also misleading in that it implies that the significant neurological damage caused to children below this "level of concern" is not a concern of the CDC, and
Realizing that in 2002 the CDC's Advisory Committee on Childhood Lead Poisoning Prevention, which is charged with assessing scientific data and recommend changes to CDC's policy to prevent childhood lead poisoning, had its panel membership changed; replacing childhood lead poisoning experts with lead industry-connected scientists,33,34 and
Realizing that the U.S. Department of Health and Human Services' regulations require clinical laboratory proficiency testing and that this testing allows laboratories to operate within a blood lead level testing error range of 8 micrograms per deciliter (± 4 micrograms per deciliter) at the lower blood lead levels.35 Understanding that this large testing error range is not warranted because at this error range it is not possible to accurately assess lower lead level toxicity occurring in children, and
Knowing the federal blood lead level testing error range is more lenient than, "external quality assessment schemes," operated in Canada and in the United Kingdom. In Canada and in the United Kingdom good laboratory performance, at a blood lead level of 10 micrograms per deciliter, is expected to be within an error range of 2 micrograms per deciliter (± 1 micrograms per deciliter),36 and
Recognizing there is no effective medical treatment for children with moderately elevated blood lead levels and the evidence supports a shift toward primary prevention of lead exposure,15,29 and
Recognizing that high blood lead levels in children is still a very serious health concern. The CDC noted that during 1999-2002, among those children aged 1 through 5 years, approximately 1.6 percent had blood lead levels greater than or equal to 10 micrograms per deciliter,37 and
Understanding that prevention is the only way to achieve the nation's 2010 health objective of reducing all young children's blood lead levels to below 10 micrograms per deciliter,38 and
Understanding that lead poisoning is one of the most serious preventable pediatric health problems today, yet the vast majority of cases go undiagnosed and untreated,30 and 
Noting that previous APHA policy statements and resolutions do not address lead in food products (candy and their wrappers) but address lead in the environment, such as lead in paint,40-45 and
Noting also that previous APHA policy statements do not address the issue of the CDC's lowering its current blood lead action level or the need to increase the accuracy of blood lead level testing, and
Recognizing that the protection of the health of children has been an expressed basic tenet of the public health profession for many years,46 and 
Recognizing that the candy imported from the Philippines and Mexico has negative health effects on children in those countries, and
Noting that the Philippines and Mexico are under legal obligation to fulfill, protect and respect child rights, specifically as stated in articles 3, 6 and 24 of the Convention on the Rights of the Child, which was signed and ratified by the Philippines and Mexico. These rights include ensuring protection, care, development of the child and enjoyment of the highest attainable standard of health. 
Therefore, the American Public Health Association:
1. Supports the elimination of childhood lead exposure by banning all nonessential uses of lead and supports further reducing the allowable levels of lead in air emission, house dust, soil, food and water.
2. Supports federal legislation to ban lead from candy wrappers and other consumer products. 
3. Supports the improvement and continual updating of the lead exposure risk-questionnaire screening guidelines to include questions on all known possible sources of lead exposure.
4. Supports the development of an aggressive culturally and linguistically appropriate prevention and education program, by public health workers, to teach the public about the dangers and effects of consuming imported candy and their wrappers with high lead levels.
5. Supports additional scientific studies to more fully understand the toxic effects of lead in children at blood lead levels below 10 micrograms per deciliter. 
6. Calls on Congress to direct the FDA, in FDA's next appropriations bill, to prioritize work on setting lead level standards for salt-based candy and reviewing its current lead level standards for sugar-based candy. 
7. Calls on the FDA to set a lead enforcement standard of 0.1 ppm for all candy sold in the United States (regulating domestic and imported candy, including salt-based seasonings that are consumed as candy and which are made in Mexico).
8. Calls on the FDA to conduct sufficient monitoring of candy and to take aggressive enforcement action when its lead standards are exceeded.
9. Calls on the U.S. Consumer Product Safety Commission to strongly enforce the ban on the importation of candy from Mexico containing lead contaminated candy wrappers, as detailed in their July 2004 letters to Mexican candy manufacturers and to U.S. candy importers.
10. Calls on the CDC to substantially lower its current "blood lead level of concern" because the current action level is set too high and does not adequately protect children from the toxic effects of lead.
11. Calls on the CDC to develop intervention guidelines for children with blood lead levels above the revised "level of concern" and below 10 micrograms per deciliter, with an emphasis on preventing all possible sources of childhood exposures to lead.
12. Calls on the Department of Health and Human Services to amend its regulatory requirement and require all laboratories, certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988, to operate with a total allowable blood lead level error of ± 1 microgram per deciliter or ± 10%, whichever is greater.
13. Calls on the governments of the Philippines and Mexico, as well as Public Health Associations of those countries, to address this child health risk. 

14. Calls on the Committee on the Convention of the Rights of the Child, a monitoring body at the U.N., to address this risk of lead exposure from candy produced in the Philippines and Mexico.

References:
1 McKim JB, Sharon K, Heisel W. Toxic treats. Orange County Register. April 25, 2004. http://www.ocregister.com/investigations/2004/lead/index.shtml (Accessed June 16, 2005).

2 Wagner B, Sobsey R. Lead in Mexican candies and powders pose a hidden threat, Sept 22, 2004. http://www.co.washoe.nv.us/health/ (Accessed June 16, 2005).

3 US Centers for Disease Control and Prevention. Lead poisoning associated with imported candy and powder food coloring California and Michigan. 1998;47(48):1041-1043 Morbidity and Mortality Weekly Report, Atlanta, Ga. http://www.cdc.gov/mmwr/preview/mmwrhtml/00055939.htm (Accessed June 16, 2005).

4 US Centers for Disease Control and Prevention. Childhood lead poisoning associated with tamarind candy and folk remedies---California, 1999 2000. 2002;51(31):684-686 Morbidity and Mortality Weekly Report, Atlanta, Ga. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5131a3.htm (Accessed June 16, 2005).

5 Carrington CD, Bolger PM. Division of Toxicological Review and Evaluation (HFF-156), Food and Drug Administration. An assessment of the hazards of lead in food. Regul Toxicol Pharmacol 1992;16:265-72.

6 US Food and Drug Administration. FDA Import Alert #33-10, Revised 4/8/04. Detention without physical examination of candy from Mexico and the Philippines due to lead.

7 Food Chemicals Codex, Fifth Edition, National Academies Press, Washington, D.C., 2003:455-456.

8 FDA statement on lead contamination in certain candy products imported form Mexico. April 9, 2004. http://www.fda.gov/bbs/topics/news/2004/NEW01048.html (Accessed June 16, 2005).

9 Lucas® voluntarily withdraws four seasoning products from U.S. market. August 7, 2004. http://www.ocregister.com/investigations/2004/lead/pdf/080704pressrelease2.pdf (Accessed June 16, 2005).

10 McKim JB. Lead-laced candy is still on shelves. April 30, 2005. http://www.ocregister.com/ocr/2005/04/30/sections/news/focus_health/article_501452.php (Accessed June 16, 2005).

11 US Consumer Product Safety Commission. CPSC overview. http://www.cpsc.gov/about/about.html (Accessed June 16, 2005).

12 US Consumer Product Safety Commission. Letter to candy producers in Mexico (English version) July 12, 2004. http://www.cpsc.gov/BUSINFO/cndymex.pdf (Accessed June 16, 2005).

13 US Consumer Product Safety Commission. Letter to US candy importers July 9, 2004. http://www.cpsc.gov/BUSINFO/cndyus.pdf (Accessed June 16, 2005).

14 H.R.668.IH: To direct the Consumer Product Safety Commission to classify certain children's products containing lead to be banned hazardous substances. Introduced Feb. 8, 2005, 109th Congress. 

15 Canfield RL, Henderson CR, Cory-Slechta DA, Cox C, et al. Intellectual impairment in children with blood lead concentrations below 10 mg per deciliter. N Engl J Med 2003; 348: 1517-26.

16 US Department of Health and Human Services, National Toxicology Program. Lead (CAS No. 7439-92-1) and Lead Compounds*. Eleventh report on carcinogens (2004). http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s101lead.pdf (Accessed June 16, 2005) . 

17 Winneke G, Lilienthal H, Kramer U. The neurobehavioral toxicology and teratology of lead. Arch Toxicology 1996; 18(Suppl):57-70.

18 Landrigan PJ, Todd AC, Wedeen RP. Lead poisoning. Mount Sinai Journal of Medicine 1995;62:360-364

19 Bellinger D, Dietrich KN, Low-level lead exposure and cognitive function in children. Pediatric Annals 1994;23(11):600-605

20 Needleman HL. The current status of childhood low-level lead toxicity. Neurotoxicol 1993;14(2-3);161-166

21 Needleman HL, Gatsonis CA, Low-level lead exposure and the IQ of children, JAMA 1990;263:673-678

22 Schwartz J. Low-level exposure and children's IQ: A meta-analysis and search for a threshold. Environmental Research 1994;65:42-55

23 US Centers for Disease Control and Prevention. Work Group of the Advisory Committee on Childhood Lead Poisoning Prevention. A review of evidence of health effects of blood lead levels <10 mg/dL in children. Atalnta, Ga.;2004. http://www.cdc.gov/nceh/lead/ACCLPP/SupplementalOct04/Work%20Group%20Draft%20Final%20Report_Edited%20October%207,%202004%20-%20single%20spaced.pdf (Accessed June 16, 2005).

24 Rogan WJ, Ware JH, Exposure to lead in children how low is low enough? N Engl J Med 2003;348:1515-16. http://www.ecy.wa.gov/programs/tcp/area_wide/Rogan%20and%20Ware%20Perspective.pdf (Accessed June 16, 2005).

25 Jusko TA, Canfield RL, Henderson CR, Lanpher BP, Correspondence: Comments on "Recent Developments in Low-Level Lead Exposoure and Intellectual Impairment in Children". Environ Health Perspect 2005;113:A16. Retrieved 16 June 2005. http://ehp.niehs.nih.gov/docs/2005/113-1/EHP113pa16PDF.pdf

26 Koller K, Levy L, Brown T, Correspondence: Low-level lead exposure and intellectual imparment in children: Koller et al. respond. Environ Health Perspect:2005;113:A16-A17. http://ehp.niehs.nih.gov/docs/2005/113-1/EHP113pa16PDF.pdf (Accessed June 16, 2005)

27 Bellinger, D.C., Needleman, H.L., Correspondence: Intellectual impairment and blood lead levels. N Engl J Med. 2003; 349:500-502

28 Lanphear, B.P., Dietrich, K.., Auinger P., Cox, C. Cognitive deficits associated with blood lead concentrations < 10 mg/dL in US children and adolescents. Public Health Rep. 2000;115:521-529

29 Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg S.J, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R. Low-level environmental lead exposure and children's intellectual function: an international pooled analysis. Environ Health Perspect 2005;113:894-899. http://ehp.niehs.nih.gov/members/2005/7688/7688.html (Accessed June 16, 2005)

30 US Centers for Disease Control and Prevention. Preventing lead poisoning in young children, Atlanta, Ga.: US DHHS, 1991. http://wonder.cdc.gov/wonder/prevguid/p0000029/p0000029.asp (Accessed June 16, 2005).

31 Bellinger DC. Lead. Pediatrics 2004;113(4):1016-1022. http://pediatrics.aappublications.org/cgi/content/full/113/4/S1/1016 (Accessed June 16, 2005).

32 US Centers for Disease Control and Prevention. Why not change the blood lead level of concern at this time? Atlanta, Ga. http://www.cdc.gov/nceh/lead/spotLights/changeBLL.htm (Accessed June 16, 2005).

33 Environmental Working Group. Lead astray, Ohio is failing to protect children from lead poisoning, section 4: Bush administration stymies added protections. http://www.ewg.org/reports/ohiolead/reducedprotection.php (Accessed June 16, 2005).

34 American Public Health Association (APHA). Ensuring the Scientific Credibility of Government Public Health Advisory Committees. Association News. Policy Statement 20036. Washington, D.C. 2003. http://www.apha.org/legislative/policy/policysearch/index.cfm?fuseaction=view&id=1242 (Accessed June 16, 2005).

35 Title 42 CFR section 493.937

36 Parsons PJ, Reilly AA, Esernio-Jenssen D, Werk LN, et al., Evaluation of blood lead proficiency testing: comparison of open and blind paradigms. Clin Chem. 2001;47:322-330 http://www.clinchem.org/cgi/content/full/47/2/322#R4 (Accessed June 16, 2005).

37 US Centers for Disease Control and Prevention. Blood lead levels---United States, 1999--2002. 2005:54(20);513-516 Morbidity and Mortality Weekly Report, Atlanta, Ga. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5420a5.htm (Accessed June 16, 2005).

38 US Department of Health and Human Services, Office of Disease Prevention and Health Promotion. Healthy People 2010, 2000;Section 8-11. 

39 Fuortes L, Bauer E. Lead contamination of imported candy wrappers. Vet Hum Toxicol 2000;42:41-2.

40 APHA Policy No. 6902: Childhood lead poisoning. Amendment: Policy No. 7001.

41 APHA Policy No. 7211: Lead in the environment.

42 APHA Policy No. 8508: Health risks related to lead exposure. 

43 APHA Policy No. 8909: Environmental lead exposure.

44 APHA Policy No. 9704: Lead poisoning in paint.

45 APHA Policy No. 9907: Ensuring the safety of the food supply (relating to foodborne illnesses) in the United States.

46 APHA Policy No. 7227 (pp): Child health and public policy background.