Q. When did the California Department of Public Health (CDPH) discover that its soft-sided lunch boxes have an elevated level of lead?
Q. Before the lunch boxes were distributed by CDPH, were they tested for lead?
Q. What further action was taken by CDPH after learning of the test result from Sacramento County?
Q. Why did Sacramento County test the lunch boxes?
Q. How many lunch boxes were distributed?
Q. How much lead was found in the lunch boxes? What is the accepted lead standard allowed for products?
Q. What should consumers do if they have one of the department’s lunch boxes?
Q. Do these lunch boxes pose a health risk?
Q. What about other promotional products distributed by CDPH?
Q. Where can I get more information?
Q. For what contaminants/chemicals and at what levels are items classified as either unsafe for the consumer marketplace or hazardous household waste? Which agencies/authorities have the authority to recall or declare items as unsafe?
Q. What are the various types of items for which there are laws, regulations, or voluntary standards, and what is a manufacturer’s responsibility for complying with such requirements? What kind of enforcement is there? Is there a consumer guide somewhere that explains this?
Q. What is a safe level (PPM) to test for lead? We want to make sure that companies from which we have purchased items, or from which we might purchase in the future, (once final guidelines are given and the moratorium is lifted) are testing at least at the level with which the CDPH agrees
Q. Can you explain types of articles and chemicals for which different regulatory agencies have jurisdiction?
Q. What is the proper laboratory process to test items like the following for lead:
Q. Where can we get our items tested? Can CDPH or some other entity provide a list of certified labs?
Q. How should the sample size for the number of items of any class be determined? If an item has multiple materials, how do we decide which parts and how many different samples to test?
Q. How much should such tests cost?
Q. Are there tests to avoid?
Q. Alternatively, are there manufacturer specifications that we would be setting or looking for when we buy items in the marketplace?
Q. Are there any disadvantages of our performing our own tests locally?
Q. When did the California Department of Public Health (CDPH) discover that its soft-sided lunch boxes have an elevated level of lead?
A. In late July, CDPH was notified by the Sacramento County Environmental Health Department (EHD) of a positive lead check swab test for lead on one of the green, soft-sided lunch boxes distributed by CDPH’s Cancer Prevention and Nutrition Section. The swab test was an initial screening test for which there can be false positives and false negatives. Additional confirmatory testing was conducted as recommended by the Attorney General’s Office, Proposition 65 Coordinator. (Please see further discussion on screening and testing of products in question on testing below.)
Q. Before the lunch boxes were distributed by CDPH, were they tested for lead?
A. Testing was conducted twice for lead content, one by the manufacturer in China and another by a testing company in California. Neither of the tests indicated high levels of lead.
Q. What further action was taken by CDPH after learning of the test result from Sacramento County?
A. Subsequent testing was completed by the Proposition 65 office via the Department of Toxic Substances Control and the National Food Laboratory.
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Q. Why did Sacramento County test the lunch boxes?
A. Concerned about recent news updates regarding lead in toys manufactured in China, health educators at the Sacramento County Dept. of Public Health proposed developing a policy that no items with any lead be used as promotional items. They requested testing by the Sacramento County EHD as part of their policy planning.
Q. How many lunch boxes were distributed?
A. Approximately 56,000 green lunch boxes were distributed to local partners in California. In addition, approximately 247,000 blue lunch boxes were distributed as promotional items for the Network for a Healthy California and the Women, Infants and Children (WIC) Nutrition program. Of the approximately 303,000 green and blue lunch boxes, most were distributed by our partners to the public. However, some of the lunch boxes were not distributed and remain in warehouses.
Q. How much lead was found in the lunch boxes? What is the accepted lead standard allowed for products?
A. The painted logo had a lead level of 1,700 PPM, which exceeds the federal lead limit of 600 PPM in painted products used by children. This elevated level was reported to the Consumer Product Safety Commission on September 17, 2007. While the exposure to lead from the lunch boxes is unlikely to result in any immediate health effects, lead ingestion should be avoided since elevated blood lead levels from chronic lead exposure can lead to serious, adverse health effects such as behavioral problems, learning disabilities and organ compromise.
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Q. What should consumers do if they have one of the department’s lunch boxes?
A. They should stop using the lunch box for any purpose and keep it away from infants and small children. The lunch box should be returned to the place where it was obtained, if possible, or taken to a local household hazardous waste collection facility for disposal. Local collection facilities can be found at the following Web sites:
· http://www.dtsc.ca.gov/HazardousWaste/UniversalWaste/HHW.cfm
· http://www.earth911.com
· http://www.ciwmb.ca.gov
Q. Do these lunch boxes pose a health risk?
A. It is unlikely that any child will become acutely ill from exposure to lead from these lunch boxes because lead poisoning typically occurs after repeated exposure. Because some of these lunch boxes may have lead in the painted logo or on their surfaces, there is the potential for food to become contaminated with lead and then ingested. Due to variations in the manufacturing process, the lead content and potential for food contamination could vary among lunch boxes of the same type.
However, lead exposure is cumulative and we want to do everything in our power to eliminate any possible exposure to children. That’s why we are being proactive and asking consumers to stop using green and blue lunch boxes distributed by CDPH and to keep them away from infants and small children.
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Q. What about other promotional products distributed by CDPH?
A. CDPH is currently assessing the potential risks of all of its promotional products.
Q. Where can I get more information?
A. Information can be found at the following web site: www.cdph.ca.gov
Q. For what contaminants/chemicals and at what levels are items classified as either unsafe for the consumer marketplace or hazardous household waste? Which agencies/authorities have the authority to recall or declare items as unsafe?
A. There is no comprehensive single source for this information. The reply to the next question immediately below contains levels of lead that have been set for a variety of items. Information on a number of agencies is supplied in the answer to the question on regulatory agencies below.
Additional lead standards and authorities related to lead, and information on other chemicals, can be found at:
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Q. What are the various types of items for which there are laws, regulations, or voluntary standards, and what is a manufacturer’s responsibility for complying with such requirements? What kind of enforcement is there? Is there a consumer guide somewhere that explains this?
A. There is no consumer guide.
California laws can be found at http://www.leginfo.ca.gov for items such as plumbing fixtures, jewelry, candy, packaging, and ceramic ware.
For voluntary standards, information may be found at: http://www.cpsc.gov/cgi-bin/regs.aspx
Proposition 65 levels for chemicals that can cause cancer or reproductive harm can be found at: http://www.oehha.ca.gov/prop65.html
DTSC information on wastes and hazard classification can be found at: http://www.dtsc.ca.gov
For lead standards in products to be used by or in connection with children, the American Academy of Pediatrics (AAP) has recently recommended no more than trace amounts of lead be allowed. The AAP defined trace amounts at 40 parts per million. (Testimony of Dana Best, M.D., at the Energy and Commerce Subcommittee on Commerce, Trade, and Consumer Protection, "Protecting Children from Lead-Tainted Imports," September 20, 2007)
Some examples of current regulatory levels for lead are given in the table below.
|
Material |
Maximum Allowable Lead Level |
Regulating Agency |
Comments |
|
|
|
|
|
|
Paint |
600 ppm (dry weight) |
CPSC |
Standard for residential and public use |
|
Soil (residential play areas) |
400 ppm |
EPA |
|
|
Soil (residential non-play areas) |
1200 ppm |
EPA |
|
|
Soil (residential play areas) |
400 ppm |
DTSC |
|
|
Soil (all other) |
1000 ppm |
DTSC |
|
|
Dust |
40 mcg/sq ft (interior floor) |
EPA |
California currently adopting this federal standard |
|
Dust |
250 mcg/sq ft (interior window sills) |
EPA |
|
|
Dust |
400 mcg/sq ft (exterior window sills) |
EPA |
|
|
Drinking water |
15 ppb |
EPA |
90th % ile action level |
|
Children's jewelry |
|
|
|
|
Nonmetallic |
|
|
|
|
Before 8/31/09 |
600 ppm |
DTSC |
|
|
After 8/31/09 |
200 ppm |
DTSC |
|
|
Dyes or surface coatings |
600 ppm |
DTSC |
|
|
Metallic |
600 ppm |
DTSC |
|
|
Glass or crystal |
200 ppm |
DTSC |
|
|
Printed ink or ceramic glaze |
600 ppm |
DTSC |
|
|
Tableware - FDA/CDPH* |
|
|
|
|
Flatware (plates) |
3.0 ppm (leach level) |
FDA/CDPH |
|
|
Small hollowware (bowls) |
2.0 ppm (leach level) |
FDA/CDPH |
|
|
Large hollowware(serving
dishes) |
1.0 ppm (leach level) |
FDA/CDPH |
|
|
Cups or mugs |
0.5 ppm (leach level) |
FDA/CDPH |
|
|
Large pitchers, jugs |
0.5 ppm (leach level) |
FDA/CDPH |
|
|
Tableware - Proposition 65** |
|
|
|
|
Flatware (plates) |
0.226 ppm (leach level) |
California Proposition 65 |
|
|
Small hollowware (bowls) |
0.1 ppm (leach level) |
California Proposition 65 |
|
|
Large hollowware (serving
dishes) |
0.1 ppm (leach level) |
California Proposition 65 |
|
|
Cups or mugs |
0.1 ppm (leach level) |
California Proposition 65 |
|
|
Large pitchers, jugs |
0.1 ppm (leach level) |
California Proposition 65 |
|
|
Candy likely to be consumed by children |
0.1 ppm |
FDA |
|
* Products containing these lead levels cannot be legally sold in the US.
** Products containing these lead levels must carry a Proposition 65 warning when sold in California
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Q. What is a safe level (PPM) to test for lead? We want to make sure that companies from which we have purchased items, or from which we might purchase in the future, (once final guidelines are given and the moratorium is lifted) are testing at least at the level with which the CDPH agrees.
A. This will depend on the item and potential exposure from the item. The US FDA recommends that children not take in more than 6 micrograms of lead a day. California's Proposition 65 sets limits of intake at 0.5 micrograms of lead a day for reproductive toxicity.
As mentioned in the question above, for lead standards in products to be used by or in connection with children, the American Academy of Pediatrics has recently recommended no more than trace amounts of lead be allowed. They defined trace amounts at 40 parts per million based on information on naturally occurring lead levels.
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Q. Can you explain types of articles and chemicals for which different regulatory agencies have jurisdiction?
A. Descriptions of functions of agencies regulating articles and chemicals are given here:
a. Attorney General, Prop 65 (California)
Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. The Proposition was intended by its authors to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals. Proposition 65 requires the Governor to publish, at least annually, a list of chemicals known to the state to cause cancer or reproductive toxicity. The Attorney General or private citizens can commence civil lawsuits for violation of Proposition 65. Lead is one of the chemicals on the lists for carcinogens and reproductive harm.
b. Department of Toxic Substances Control (California)
The Department of Toxic Substances Control (DTSC) regulates hazardous waste, cleans-up existing contamination, and looks for ways to reduce the hazardous waste produced in California. DTSC regulates hazardous waste in California primarily under the authority of the federal Resource Conservation and Recovery Act of 1976, and the California Health and Safety Code. As part of their responsibilities, DTSC has established the criteria for determining if a waste product is hazardous. DTSC now is also responsible for enforcing a new law establishing standards for lead in jewelry.
c. Integrated Waste Management Board (California)
The California Integrated Waste Management Board is the State agency designated to oversee, manage, and track California's 92 million tons of waste generated each year. This agency regulates the handling, disposal and recycling of non hazardous waste and also regulates recycling and composting operations. The Board regulates traditional local landfills mostly through local enforcement agencies (LEA's). In addition, the Board provides grants and loans to help California cities, counties, businesses, and organizations meet the State's waste reduction, reuse, and recycling goals. It also provides funds to clean up solid waste disposal sites and co-disposal sites (those accepting both hazardous waste substances and nonhazardous waste). These funds are available when the responsible party cannot be identified or is unable or unwilling to pay for a timely remediation and where cleanup is needed to protect public health, safety or the environment.
d. CUPA-Certified Uniform Program Agencies (California)
The Unified Program is the consolidation of six state environmental programs into one program under the authority of a Certified Unified Program Agency (CUPA). These can be a county, city or Joint Powers Authority. This program was established under the amendments to the California Health and Safety Code made by SB 1082 in 1994. The environmental programs are the Hazardous Materials Business Plan/Emergency Response Plan, Hazardous Waste/Tiered Permitting, Underground Storage Tanks, above ground Storage Tanks, California Accidental Release Program and the Uniform Fire Code Hazardous Materials Management Plan. CUPA agencies are the local agencies under contract with Cal-EPA to perform activities relating to hazardous materials and waste. Most of the CUPA are local environmental health departments with some jurisdictions electing to designate fire departments as their CUPAs. As a matter of operation, CUPA's will respond to all activities relating to hazardous material in their jurisdiction including such diverse activities as emergency response, contaminated sites such as illegal drug labs, and to current issues such as consumer products contaminated by hazardous materials.
e. California EPA
Cal-EPA is the parent agency of Departments dealing with environmental issues. The California Environmental Protection Agency (Cal/EPA) was created in 1991 by a Governor's Executive Order. The six Boards, Departments and Office were placed within the Cal/EPA "umbrella". The six agencies are the Air Resources Board (ARB), the Department of Pesticide Regulation (DPR), the Department of Toxic Substances (DTSC), the Integrated Waste Management Board (IWMB), the Office of Environmental Health Hazard Assessment (OEHHA) and the State Water Resources Control Board. Cal/EPA’s mission is to restore, protect and enhance the environment, to ensure public health, environmental quality and economic vitality. Cal EPA directly regulates and supervises the local jurisdictions activities related to hazardous materials through the CUPA program.
f. US Consumer Product Safety Commission
The Consumer Product Safety Commission (CPSC) was created in 1972 by Congress under the Consumer Product Safety Act and began operating in 1973. The CPSC 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. CPSC develops voluntary product standards with industry, issues and enforces mandatory product standards; issues mandatory and voluntary product recalls and performs research on product hazards.
g. US EPA
The federal Environmental Protection Agency (EPA) works to develop and enforce regulations that implement environmental laws enacted by Congress. EPA is responsible for researching and setting national standards for a variety of environmental programs, and delegates to states and tribes the responsibility for issuing permits and for monitoring and enforcing compliance. Where national standards are not met, EPA can issue sanctions and take other steps to assist the states and tribes in reaching the desired levels of environmental quality. More than a dozen major statutes or laws form the legal basis for the programs of the EPA. Some of these statutes include the Toxic Substances Control Act (TSCA), the Resource Conservation and Recovery Act (RCRA) and the Occupational Safety and Health Act (OSHA). EPA has cooperative agreements with state agencies to enforce a number of their laws. Some examples include CDFA (Pesticides), CDPH (Drinking Water, Childhood Lead Poisoning Prevention Program), and Cal-EPA (DTSC, Integrated Solid Waste Management Board)
h. US FDA
The Food and Drug Administration (FDA) is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Part of their responsibility includes setting standards for chemicals in food and enforcing those standards.
Basic information on agency responsibilities and laws are given on their individual websites. This has been changing for lead as it has been recognized that there is no known safe lower level of blood lead and as agencies update their mandates and responsibilities. Please refer to the web sites or contact the regulatory agencies directly to obtain the most current information on their activities and on other chemicals
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Q. What is the proper laboratory process to test items like the following for lead:
a. Lunchboxes
b. Backpacks
c. Print items made of paper w/ other materials, e.g., spiral or plastic binding
d. Clothing, dyed cloth, clothing with print (T-shirts, caps)
e. Clear plastic items, with and without ink/paint
f. Opaque plastic items, with and w/o ink or paint
g. Items w/ vinyl
h. Car seats
i. Condoms
j. Toothbrushes
k. Other common items
A. In general the best definitive method for testing for is hot acid digestion followed by determination of lead concentration in the digestate using: flame atomic absorption spectroscopy (FAAS or sometimes just AAS); graphite furnace atomic absorption spectroscopy (GFAAS, a.k.a. Electro-Thermal Atomic Absorption Spectroscopy or ETAAS); Inductively Coupled Plasma - Atomic Emission Spectroscopy (ICP-AES); or Inductively Coupled Plasma - mass spectroscopy (ICP-MS).
Some regulations require specific tests or specific modes of testing, in which case the specified test protocol or method for the regulation should be used. Often, specified testing methods are based on the type or mechanism of expected exposure (i.e. pitchers are leached with a weak acid that simulates an acidic beverage; exposure through contact with a solid object is often simulated by some sort of wipe test.) Any of the testing methods should employ one of the methods of quantization mentioned above, to assure the detection of low levels of lead.
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Q. Where can we get our items tested? Can CDPH or some other entity provide a list of certified labs?
A. The best approach is to check with the major laboratory accreditation organizations for the specific field of testing (generally defined by the kind of item to be tested). The major laboratory accreditation organizations are:
American Industrial Hygiene Association (<http://www.aiha.org/Content/LQAP/accred/accreditation.htm>)
American Association for Laboratory Accreditation (<http://www.a2la.org/Applications/ApplyTestLab.cfm>)
CDPH can not provide a comprehensive list of certified labs, as the list and the requirements for laboratories to be on the list change. However, our Environmental Health Laboratory Branch can provide you with a list of some laboratories, or laboratories in a specific area. They can be accessed through: http://www.dhs.ca.gov/ps/deodc/ehlb/default.htm
Q. How should the sample size for the number of items of any class be determined? If an item has multiple materials, how do we decide which parts and how many different samples to test?
A. Different levels of lead contamination may be found in different lots and batches of items, and lead levels may not be uniform for different components of the same item. Therefore, sample testing may not provide reassurance of safety for similar, but not tested, items. Thus, testing might best be able to “rule in” items as likely contaminated or be used to get a sense of what the level of contamination might be. To be safe, test every significant component, part, and material of an item separately.
The sample size for testing will depend on the item, the degree of homogeneity within each batch for the item to be tested and the degree of uniformity in production between batches. It will also depend on whether the item you are testing is known to come from a single batch or production source, or represents items from different batches and production sources. These testing considerations apply to each component in a multi-component item.
Approaches to suggested testing may vary by the agency doing the testing. The state agency that has been designated for taking the lead in testing and for testing items from other state agencies is DTSC.
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Q. How much should such tests cost?
A. For commonly requested, large volume tests, $10.00 to $50.00 per test. For less commonly tested items, $50.00 and up to several hundred dollars, depending on the difficulty of the material to be tested. For the less commonly tested item, quoted prices might be variable, so checking around is recommended.
There is significant variation because there are different types of tests, and commercial labs are free to charge as much or as little as they like. As a rough point of reference, a contract laboratory used by CDPH gave an estimate for an item that we wanted tested:
Total lead digest test of type noted in question 5 - $15 for each component or material to be tested
Wipe test to check for lead on surface of item - 3 wipes per test surface x $15 each = $45 each surface
Leach test to check for lead leaching out of an item, such as pitchers mentioned in question 5 - $120
Q. Are there tests to avoid?
A. Colorimetric and electro-chemical methods are generally not sensitive or precise enough for lead. X-ray fluorescence is theoretically capable of attaining an appropriate level of accuracy and precision, but presents a number of possible interferences that require a much higher level of reliance on the expertise and technique of the operator. Some agencies are using X-ray fluorescence as a screening device and then carrying out more quantitative analysis if levels of lead are detected. All laboratories should be able to supply statistical quality control data which should allow you to determine whether their performance meets your needs for tests that the laboratory does routinely.
You should also know that CPSC recently issued a press release announcing that home lead test kits are unreliable. The press release can be found at: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08038.html
CPSC stated that: "Of 104 total test results, more than half (56) were false negatives, and two were false positives. None of the kits consistently detected lead in products if the lead was covered with a non-leaded coating. Based on the study consumers should not use lead test kits to evaluate consumer products for potential lead hazards."
To evaluate lead test kits, CPSC tested various paint samples, a vinyl lunch box, jewelry, crayons, and a steel washer. The false negatives discussed were for items which had some type of lead-free surface coating (e.g. leaded paint covered with a layer of lead-free paint, leaded jewelry with a lead free plated surface). The accuracy of the results for vinyl lunch boxes was not specified. The two false positive results were for items which were red. Further details about the CPSC testing of home lead kits can be found at: http://www.cpsc.gov/cpscpub/prerel/prhtml08/lead.pdf
When using the lead check kit as a screening tool please keep the following limitations in mind:
· The kits only detect accessible or surface lead. They are not reliable for detecting lead if the item has some type of lead-free coating.
· There can be false positives when testing items which are the same color as a positive test result (i.e. testing a red or pink item with a swab that turns red or pink to indicate lead is present). However, these colored items may also contain lead, so it should not be assumed that the tests are false positives.
· The kits may not be reliable for detecting lead at levels near or below 600 ppm (the CPSC limit for lead in paint).
· If a lead check test result is positive, the item should be considered positive for lead unless proven otherwise.
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Q. Alternatively, are there manufacturer specifications that we would be setting or looking for when we buy items in the marketplace?
A. Products should comply with existing laws and standards and with known safety issues. Products should be reviewed for any identified hazards or recalls.
Q. Are there any disadvantages of our performing our own tests locally?
A. Assuming that the local testing meets all of the same quality control and quality assurance as a remote laboratory -- generally understood to be the practices outlined in the ISO 17025 guidelines (International Organization for Standardization general requirements for the competence of testing and calibration laboratories) -- and that the local tester has the same accreditations, the disadvantage of testing locally may be cost.
Should you have questions, please post them to the following e-mail address: promo-items-and-lead@cdph.ca.gov. To assist CDPH in responding to your inquiry, please fill out the subject line with as much detail as possible, a full description of your question, and your contact information so that your email can be triaged to the correct office for a response. This site will serve as the central repository for administrative questions on this matter. Please return to this website for new information. It will be posted here as it becomes available.