CPSIA: Children\'s Product

What is the definition of a children's product and how will the age cutoffs be determined?

A "children’s product" means a consumer product designed or intended primarily for children 12 years of age or younger. In determining whether a consumer product is primarily intended for a child 12 years of age or younger, the following factors will be considered:

• A statement by the manufacturer about the intended use of the product, including a label on the product if such statement is reasonable.
  
  
• Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by children 12 years of age or younger.
  
  
• Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.
  
  
• The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.
  
  

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Section 101: Children’s Products Containing Lead;Lead Paint Rule

Will the CPSC consider exclusions for categories of products or materials based on age or other factors?

Some children’s products may be exempted or excluded from the new lead limits particularly if the only parts containing lead are inaccessible. A component part is not accessible if the component part is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product. The CPSIA directs the Commission to provide guidance by rule within one year on what component parts are considered inaccessible. The Commission will also be evaluating whether certain electronic devices, including devices that contain batteries, must comply with the lead limit. CPSC will host a public meeting on November 6, 2008 that will provide an opportunity for participants to share their views with Commission staff regarding what product components, or classes of components, should be considered inaccessible to a child through ordinary use and abuse and on whether it will be technologically feasible for certain electronic devices to meet the new lead limits.

Please clarify section 101(f)(3) regarding lead paint testing and whether small areas are exempt from testing.

The new law does not exempt small painted areas from the applicable lead limits. It does allow the Commission to rely on x-ray fluorescence technology (XRF) or other alternative means to screen for products bearing lead paint where the total weight of such paint or surface coating is no greater than 10 milligrams or where the surface area of such paint or surface coating covers no more than 1 square centimeter of the surface area of such products. This alternative method for measurement may not allow more than 2 micrograms of lead in a total weight of 10 milligrams of paint or other surface coating or in a surface area of 1 square centimeter or less.

Once the ASTM F963-07 Toy Standard becomes mandatory, will toys need to be tested for lead and other heavy metals in paint according to F963-07 or according to 16 CFR § 1303.1 or both?

The answer to this question will change over the course of the next year. Until February 10, 2009, toys must meet CPSC’s lead paint rule at 16 C.F.R. § 1303.1. For paint and similar surface coatings, and certain consumer products, 16 CFR § 1303.1 specifies that the maximum allowable total lead content is 0.06% based on the total weight of the non-volatile portion of the paint (which is equivalent to 600 ppm). As of August 14, 2009, the maximum allowable total lead content of such items will fall to 0.009% (which is equivalent to 90 ppm). The test method for compliance with 16 CFR § 1303.1 used by the CPSC staff is available on the CPSC website at: http://www.cpsc.gov/about/cpsia/CPSC-CH-E1003-09.pdf.

The Standard Consumer Safety Specification for Toy Safety, ASTM F963-07 becomes a mandatory consumer product safety standard on February 10, 2009. This standard additionally places limits on the amount of lead (and other heavy metals, namely antimony, arsenic, barium, cadmium, chromium, mercury and selenium) based on the soluble portion of that material using a specified extraction methodology given in the standard. Toys manufactured after February 10, 2009, will have to meet these requirements.

Beginning on August 14, 2009, however, the soluble limit testing for lead paint under ASTM F963-07 will not be necessary because the maximum total lead content in paint will be reduced to 90 ppm in 16 CFR § 1303.1, which would be a more stringent requirement in all cases. It will remain necessary to conduct ASTM F963-07 solubility testing for antimony, arsenic, barium, cadmium, chromium, mercury, and selenium, as those are not covered by 16 CFR § 1303.1.

Is compositing allowed for testing for lead in the surface paint/coating or in the substrates (that is the underlying materials that are painted or coated)?

The term "compositing" could refer to more than one type of combination. One type of compositing that labs have used is to combine like paint from several like parts or products to obtain a sufficient sample size for analysis where there is not sufficient quantity of paint on one item to perform the testing. This is appropriate in this circumstance and may even be necessary to obtain valid analytical results.

Another type of compositing is to combine different paints or substrates from one or more samples to reduce the number of tests run. This type of composite testing may fail to detect excessive levels of lead in one individual paint or substrate because they have been diluted. This approach is therefore not acceptable.

Under 16 CFR § 1303.2, electroplating is exempt from the ban on lead containing paint and similar surface coating materials, is this the same under the new statute? Would electroplating a substrate allow the substrate to be considered "inaccessible"?

For lead containing children’s products, CPSIA specifically provides that paint, coatings, or electroplating may not be considered a barrier that would render lead in the substrate inaccessible to a child. Accordingly, electroplating a substrate will not provide a basis for exempting a children’s product from having to meet the lead content limits specified in CPSIA. For items covered by 16 CFR part 1303, including paint, and certain painted items, the definition of paint and other similar surface coatings remains the same and still does not include electroplating.

Does the new requirement for total lead on children's products apply to children's books, cassettes and CD's, printed game boards, posters and other printed goods used for children's education?

In general, yes. CPSIA defines children’s products as those products intended primarily for use by children 12 and under. Accordingly, these products would be subject to the lead limit for paint and surface coatings at 16 CFR part 1303 (and the 90 ppm lead paint limit effective August 14, 2009) as well as the new lead limits for children’s products containing lead (600 ppm lead limit effective February 10, 2009, and 300 ppm lead limit effective August 14, 2009). If the children’s products use printing inks or materials which actually become a part of the substrate, such as the pigment in a plastic article, or those materials which are actually bonded to the substrate, such as by electroplating or ceramic glazing, they would be excluded from the lead paint limit. However, these products are still considered to be lead containing products irrespective of whether such products are excluded from the lead paint limit and are subject to the lead limits for children’s products containing lead. For lead containing children’s products, CPSIA specifically provides that paint, coatings, or electroplating may not be considered a barrier that would render lead in the substrate inaccessible to a child.

Is compositing of plastics and other materials allowed in regards to lead testing in substrates?

No. Compositing to combine different substrates from one or more samples may fail to detect excessive levels in one part merely because they are diluted. Accordingly, compositing of plastics or other materials to test for lead in substrates is not appropriate.

How will the new legislation affect previously issued CPSC guidelines on lead and are there any developments on the CPSC rulemaking activities on lead in children’s jewelry?

The existing lead guidelines will be superseded to the extent they conflict with the statutory requirements of CPSIA. In addition, the rulemaking commenced by the Commission on children’s metal jewelry is also superseded by the statutory requirements of CPSIA.

Does packaging have to comply with the lead requirements? Does it matter if the packaging is intended to be reused (e.g., heavy gauge reusable bag with zipper closure to store a set of blocks)?

CPSIA defines children’s products as those products intended primarily for use by children 12 and under. Packaging is generally not intended for use by children, given that most packaging is discarded and is not used or played with as a children’s product. However, if the packaging is intended to be reused, or used in conjunction with the children’s product, such as a heavy gauge reusable bag used to hold blocks, it becomes a component or part of the product, and would be subject to the lead requirements of CPSIA. It should also be noted that many individual states have adopted packaging laws which address toxics in packaging or packaging components and which have not been preempted by Commission action.

In interpreting section 101(f) of the CPSIA and 16 CFR § 1303.1, to what does the 90 ppm lead in surface-coating limit apply?

The lead limit in paint and surface coatings applies to (i) paint and other similar surface coatings; (ii) toys and other articles intended for use by children; and (iii) certain furniture articles that are not otherwise exempt under our regulations.

What furniture articles are exempt under CPSC regulations? Do the lead paint limits apply to furniture whether or not the furniture is intended for children?

16 C.F.R. § 1303.1 provides that the lead paint limits apply to toys and other articles intended for use by children, as well as furniture articles for consumer use that bear lead-containing paint. Furniture articles include, but are not limited to beds, bookcases, chairs, chests, tables, dressers, desks, pianos, console televisions, and sofas. However, they do not include appliances such as ranges, refrigerators, dishwashers, clothes washers and dryers, air conditioners, humidifiers and dehumidifiers; fixtures such as bathroom fixtures, built-in cabinets, chandeliers, windows, and doors; or household items such as window shades, venetian blinds, or wall hangings and draperies.

16 CFR part 1303 states that the liquid paint (e.g., a can of paint) must meet 600 ppm, I am curious as to how children’s products can meet 90 ppm unless the paint manufacturers lower the limit. Are the paint manufacturers required by law to meet 90 ppm?

Yes. Paint sold for consumer use must meet the 90 ppm limit by August 14, 2009 under 16 C.F.R. part 1303, which will be revised to reflect the 90 ppm lead limit specified in the CPSIA. The exemptions from the ban provided under 16 C.F.R. § 1303.3 continue to remain in effect.

Can someone import a product that has lead based paint on it? The product in question is a type of "stilt" that professional painters use to reach high ceilings and walls.

The lead paint limits only apply to certain products as described above and only apply to consumer products. In your example, the lead paint and lead content limits do not apply. Generally, a painter’s stilt is not a "consumer product" as defined under section 3 of the Consumer Product Safety Act. For example, it is not customarily sold to or used by a consumer, but rather, by professional painters in the scope of their employment. Moreover, painter’s stilts are not children’s products under the CPSIA.

Do all children's products require testing for lead or is it only products with some type of surface coating? We sell products that are used in physical education classes (e.g. hula-hoops) that are made from polyethylene and are not painted or coated. Will this product require third-party testing and certification for lead content under the new CPSIA?

All children’s products (as defined by the CPSIA) subject to the lead limit of the Act will eventually require testing for lead, not just those with surface coatings. It is important to distinguish between the rules that apply to lead paint and surface coatings and the rules that apply to lead content. The CPSIA provides limits to the amount of lead in paint and surface coatings and limits to the amount of lead in the content of the product itself. Children’s products that are painted, or have surface coatings are also subject to the lead paint limit, in addition to the lead content limits.

When do the lead paint limits go into effect for children’s products?

The lead paint limit is currently 600 ppm for children’s products. It will be lowered to 90 ppm on August 14, 2009.

What certifications are required for children’s products that are tested for lead paint?

For currently effective lead paint limits (600 ppm), general conformity certification is required for products manufactured after November 12, 2008 based on a test of the product or a reasonable testing program for products. Third-party testing of the product for currently effective lead paint limits by accredited third party laboratories is required for products manufactured after December 21, 2008.

When the lead paint limit is lowered to 90 ppm on August 14, 2009, third-party testing by accredited third party laboratories will be required for children’s products manufactured after that date.

When do the lead content limits go into effect for children’s products?

The lead content limits for all children’s products go into effect February 10, 2009 (600 ppm) and will be lowered again on August 14, 2009 (300 ppm).

What certifications are required for children’s products that are tested for lead content?

Children’s products manufactured after February 10, 2009, when the lead limit may not exceed 600 ppm, will need a general conformity certification based on a test of the product or a reasonable testing program for products after that date. Children’s products manufactured after August 14, 2009, when the lead limit may not exceed 300 ppm, will have to be certified based on third-party testing of the product by accredited third party laboratories after that date.

If you have a "children’s product" with possible lead content, do you have to have a certificate on November 12, 2008, even though the lead rule is not effective?

No. The lead content limits for children’s products do not go into effect until February 10, 2009. As stated above, children’s products manufactured after February 10, 2009 (600 ppm), will need a general conformity certification based on a test of the product or a reasonable testing program for products and children’s products manufactured after August 14, 2009 (300 ppm), will have to be certified based on third-party testing of the product by accredited third party laboratories.

Are outdoor playground products covered by CPSIA section 101 lead limits?

The lead paint limits have always applied to outdoor playground equipment and continue to apply under the CPSIA. In addition section 101, entitled "Children’s products containing lead; lead paint rule" imposes lead content limits on all children’s products, which includes outdoor playground equipment. Thus, outdoor playground products that will be used primarily by children 12 years of age or younger fall within the scope of the lead provisions of the CPSIA.

Will toys manufactured outside the United States be allowed to be imported to the US for lead testing or will the testing have to be performed outside the US (and pass the new standards) prior to being imported into the US?

Manufacturers may submit samples of products for testing in the United States without certifying them. However, before shipping any products other than these samples, i.e., products imported for consumption or warehousing or distribution in commerce in the United States, the products must have the required certifications.

Would the pending legislation for lead limits in children's products apply to video game hardware sold/distributed in the U.S.?

Under the CPSIA, the term "children’s product" means a consumer product designed or intended primarily for children 12 years of age or younger. To the extent that video game hardware is intended primarily for children 12 years and younger, it would be subject to the lead limits. The Commission is currently evaluating whether certain electronic devices, including devices that contain batteries, must comply with the lead limit. CPSC has requested comments regarding the upcoming rulemakings on what product components, or classes of components, will be considered inaccessible to a child through ordinary use and abuse and on whether it will be technologically feasible for certain electronic devices to meet the new lead limits.

Does the CPSIA envision stuffed animals falling within the scope of the CPSIA’s lead limits or phthalate limits?

Most stuffed animals would be considered to be children’s products and presumably toys. A manufacturer would need to determine whether the design of the stuffed animals is such that it is subject to the lead paint limits, the lead content limits or the phthalate limits.

How will the lead in substrate provision be applied to products like strollers, playpens and other juvenile products? Will it be applied to every single part, including rivets?

The new lead limits will apply to the total lead content by weight for any part of the product. Some children’s products or component part of products may be exempted or excluded from the new lead limits if the parts containing lead are inaccessible. Inaccessible parts do not need to meet the lead limits and the Commission will provide guidance by rule within one year on what component parts are considered inaccessible. Until that time, it is the manufacturer’s responsibility to determine which parts of its products are accessible and therefore must meet the statutory lead limits.

Is the use of XRF analysis for compliance testing with regard to lead in substrates under consideration or will wet chemistry be the only method used for testing lead content in substrates?

The use of XRF analysis for lead content is being considered. CPSC Directorate for Laboratory Sciences, Chemistry Division (LSC) will post the methods it will be using on the CPSC website in the next few months.

Can XRF technology be used to support general conformity certification as to lead paint or lead content limits?

Yes. Where third-party testing by an accredited laboratory is required as the basis for certification, that testing cannot be based on XRF technology at this time; however, XRF testing, either by a manufacturer or by a laboratory, may serve as the basis for general conformity certification. Manufacturers are cautioned, however, to be careful in their use of XRF for this purpose given the difficulties in screening for lead in paint with that technology.

What test method is CPSC requiring for surface coating lead testing and total lead content testing? When will this information be provided?

The test method for 16 CFR § 1303.1 used by the CPSC Product Testing Laboratory, Chemistry Division (LSC) is available on the CPSC website at: http://www.cpsc.gov/about/cpsia/CPSC-CH-E1003-09.pdf. Other laboratories should consider using these procedures to ensure they obtain results that are consistent with CPSC staff’s for purposes of compliance with 16 CFR part 1303. In addition, the LSC is currently developing other testing methodologies to use for total lead content testing, which will be posted on the CPSC website in the next few months.

We sell craft materials, some packages of beads can have 12 or more colors of beads. Can we composite 3 or more colors at a time to test the beads?

No. Compositing to combine different paints or substrates from one or more samples to reduce the number of tests run may fail to detect excessive levels of lead in one individual paint or substrate because of the effect of dilution by non-lead-containing samples. This approach is therefore currently not acceptable. The only exception to "compositing" is when labs have to combine like paint from several like parts or products to obtain a sufficient sample size for analysis because there is an insufficient quantity of paint on one item to perform the testing.

Are chemistry sets, science education sets and other educational materials excluded from the lead limits for content and paint and surface coatings if they bear adequate labeling under 16 C.F.R. § 1500.85?

16 C.F.R. § 1500.85 provides that certain articles that are intended for children for educational purposes are exempt for classification as a banned hazardous substance under the FHSA and the lead limits under CPSIA if the functional purpose of the particular educational item requires inclusion of the hazardous substance, and it bears labeling giving adequate directions and warnings for safe use, and is intended for use by children who have attained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings. For example, an electronics kit or robotics kit would be considered educational and the inclusion of a lead-containing component would not subject the kit to the lead testing requirements because the use of lead in some components is required to make the electronic device. Similarly, the materials used for examination or experimentation for science study such as soil, rocks, chemicals, dissections, etc. would also be exempt.

Are children’s art materials subject to the new lead limits?

Generally yes. To the extent that such art materials are designed or intended primarily for children 12 years of age or younger, they are subject to the lead limits under the CPSIA. Moreover, all art materials, whether or not intended primarily for children, must comply with the Labeling of Hazardous Art Materials Act (LHAMA) codified at 16 C.F.R. § 1500.14(b)(8), which requires that art materials be properly labeled if they present a chronic adverse health effect.

The tip on ball point pens are made from leaded brass and there is no source for materials as the lead in the brass is required to machine. Is it ok for children to use ball point pens?

The lead ban is applicable to children’s products containing lead. The term "children’s product" means a consumer product designed or intended primarily for children 12 years of age or younger. Accordingly, to the extent that these pens are general purpose items not being marketed to, or advertised as being intended for use by children 12 years or younger, these pens would not be subject to the lead limits under CPSIA.

Although it is clear that the new lead standards for children’s products cover components as well as the final product, how will CPSC consider borosilicate enamels that are vitrified with the substrate to form a product such as a children’s mug? Would the borosilicate enamel need to meet the standard as if it were a component that is a distinct separate part of that product? Or would the standard apply only to the finished glass or ceramic item where the borosilicate enamel has been vitrified with the item itself?

16 C.F.R. § 1303.2 (b)(1) provides that paint and other similar surface-coating materials does not include printing inks or those materials which actually become a part of the substrate, such as the pigment in a plastic article, or those materials which are actually bonded to the substrate, such as by electroplating or ceramic glazing. In most instances, when vitrification has occurred, the materials would be considered to be part of the substrate of the product as one whole part for testing purposes.

A bag factory in China has told me that the new requirement of lead content in the material for children’s bags (we are looking at backpacks specifically) is 300 ppm, effective August 14th. Is this a general requirement referred to in the CPSIA legislation or is there somewhere where bags and/or bag materials are referred to specifically? Is there a complete list of products that can be searched and then linked to specific rules for that product, testing requirements, etc.?

Section 101 of the CPSIA provides that any children’s product designed or intended for children 12 years of age or younger, which would also include children’s bags, must meet the lead limits. Bags and bag materials are not discussed separately in the legislation. Testing and certification requirements are set forth under section 102 of the CPSIA and are being announced on the CPSC website at http://www.cpsc.gov/about/cpsia/cpsia.html.

Do you have a complete timetable for Section 101 requirements?

ACTION	DEADLINE
Lead Paint Ban at 16 CFR part 1303	November 12, 2008 (general conformity certification required for products manufactured after that date)
Laboratory Accreditation Procedures – Lead Paint Ban	September 22, 2008 (published in the Federal Register)
Laboratory Accreditation Procedures – Children’s Metal Jewelry	December, 2008
Testing by Accredited Laboratory and Certification by Manufacturer - Lead Paint Ban	December 22, 2008 (third party testing and certification required for products manufactured after that date)
600 ppm – children’s products may not contain more than 600 ppm of lead	February 10, 2009 (general conformity certification required for products manufactured after that date )
ASTM F963-07 – surface coating materials not including lead (antimony, arsenic, barium, cadmium, chromium, mercury, selenium)	February 10, 2009 (general conformity certification required for products manufactured after that date)
Testing by Accredited Laboratory and Certification by Manufacturer - Children’s Metal Jewelry	March 2009 (third party testing and certification required for products manufactured after that date)
Laboratory Accreditation Procedures – Children’s products other than Metal Jewelry subject to 300 ppm	May 2009
Laboratory Accreditation Procedures – Lead Paint Ban – 90 ppm	May 2009
Laboratory Accreditation Procedures – ASTM F963-07 (surface coating materials not including lead)	June 2009
300 ppm - children’s products may not contain more than 300 ppm of lead	August 14, 2009 (third party testing and certification required for products manufactured after that date)
90 ppm – lead-containing paint must be reduced to 90 ppm	August 14, 2009 (third party testing and certification required for products manufactured after that date)
Guidance Rule – on product components/classes of components considered inaccessible	August 14, 2009 (and periodic review every 5 years of each new regulation)
Study on X-Ray Technology – to study effectiveness and alternative methods	August 14, 2009 (and periodic review every 5 years after study)
Electronic Devices – rule issuing requirements to eliminate/minimize accessibility of lead & compliance schedule.	No Specified Date but ASAP
Testing by Accredited Laboratory and Certification by Manufacturer (ASTM F963-07 surface coating materials not including lead)	September 2009 (third party testing and certification required for products manufactured after that date)
Laboratory Accreditation Procedures – Children’s products other than Metal Jewelry subject to 100 ppm if technologically feasible	May 2011
100 ppm – children’s products may not contain more than 100 ppm of lead if technologically feasible	August 14, 2011 (third party testing and certification required for products manufactured after that date)

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Section 102: Mandatory Third Party Testing for Certain Children's Products

General Certification of Conformity

Can electronic certificates be used to meet the requirements of Section 102 rather than paper?

The Commission has issued a rule specifically allowing use of an electronic certificate provided the Commission has reasonable access to it, it contains all of the information required by section 102 of the CPSIA, and it complies with the other requirements of the rule. The rule is available on the CPSC World Wide Web site at http://www.cpsc.gov/businfo/frnotices/fr09/certification.pdf

Who must issue the certificate?

Under the Commission's rule at http://www.cpsc.gov/businfo/frnotices/fr09/certification.pdf, for products manufactured overseas, the certificate must be issued by the importer. For products produced outside the United States, the certificate must be issued by the U.S. manufacturer. Neither a foreign manufacturer nor a private labeler is required to issue a certificate. Neither need be identified on the certificate issued by the importer or domestic manufacturer.

Must each shipment be "accompanied" by a certificate?

Yes, the law requires that each import (and domestic manufacturer) shipment be "accompanied" by the required certificate. The requirement applies to imports and products manufactured domestically. Under the rule issued by the Commission an electronic certificate is "accompanying" a shipment if the certificate is identified by a unique identifier and can be accessed via a World Wide Web URL or other electronic means, provided the URL or other electronic means and the unique identifier are created in advance and available with the shipment. Certificates can also be transmitted electronically to a broker with other customs entry documents before a shipment arrives so long as they are available to the Commission or Customs and Border Protection staff if the product or shipment is inspected.

Is the importer or U.S. manufacturer required to supply the certificate to its distributors and retailers?

Yes. The importer or U.S. manufacturer is required to "furnish" the certificate to its distributors and retailers. The Commission's rule states that this requirement is satisfied if the importer or U.S. manufacturer provides its distributors and retailers a reasonable means to access the certificate.

Must the certifier(s) sign the certificate?

No. Issuing the certificate satisfies the new law. It does not have to be signed by the issuer(s).

On what does my certification have to be based?

The general conformity certification must be based on a test of each product or a reasonable testing program.

Where must these certificates be filed?

A certificate does not have to be filed with the government. As noted above, the certificate must "accompany" the product shipment, and be "furnished" to distributors and retailers, and be furnished to CPSC upon request.

Will the CPSC review my products and determine for me: (a) whether new or previously existing regulations, standards or bans apply to my products; (b) whether I need a certificate of compliance; and (c) whether the product complies with all applicable laws?

No. The CPSC has received hundreds of requests to evaluate specific individual products and specify what bans, standards, regulations, etc., apply to those products. The Commission does not “pre-approve” products for compliance with its standards, bans, regulations or rules. It is the responsibility of the manufacturer of the product, as a normal part of doing business, to know what legal requirements of the Commission or otherwise apply to its products. The CPSC Web site provides detailed information for businesses regarding the specific products and tables of regulated products for which CPSC has issued mandatory standards (http://www.cpsc.gov/businfo/regsbyproduct.html).

Posted 12/04/2008.

My company manufactures and imports various beds, as well as night stands, dressers, chest of drawers and mirrors. What certificate and/or testing requirements under section 102 of the CPSIA do I have to follow?

A general conformity certification is required by section 102(a)(1) of the CPSIA for any product that is subject to a consumer product safety rule issued under the Consumer Product Safety Act (“CPSA”) or a similar rule, standard, regulation or ban issued under the CPSA or under any other statute administered by the Commission. That section specifies that the certificate must be based on a “test of each product or a reasonable testing program” and must certify that the product complies with each applicable Commission rule (standard, regulation or ban). The certificate must accompany the product or shipment of products and a copy must be furnished to each distributor or retailer. If the Commission requests it, a copy of the certificate must be provided to the Commission. The certification requirement applies to products manufactured after November 12, 2008.

Section 102 also specifies the information that must be on the certificate. In particular, the certificate must list each rule, standard, regulation or ban that the product is subject to. The Commission has a standard for bunk beds at 16 CFR part 1513 (bunk beds intended for children) and part 1213 (bunk beds not intended for children), but no specific standards for the other products you mention. Be aware, however, that the Commission does have flammability standards for mattresses at 16 CFR parts 1632 and 1633 if you are importing or manufacturing mattresses as well as beds. Also, be aware that the Commission has a lead paint ban that prohibits paint and similar surface coatings that have lead content above 0.06 percent on furniture articles and children’s products. See 16 CFR part 1303.

In addition to the general conformity certification requirement, section 102 also requires certification based on third-party testing for products that are primarily intended for children 12 years of age and younger and are subject to a Commission standard, rule, regulation or ban. Thus, if any of your products are primarily intended for children 12 years of age or younger, you will need to comply with the third-party testing requirements of section 102(a)(2). This requirement goes into effect 90 days after the Commission gives notice about the accreditation of testing bodies that test to the particular standard. The Commission published such notice for testing to the lead paint ban of 16 CFR part 1303 on September 22, 2008. Therefore, the third party testing requirement for lead paint will be in effect on December 22, 2008 for products manufactured on and after that date. Assuming these products may have some sort of surface coating, the lead paint ban is likely applicable.

Posted 12/04/2008.

Section 102 Certification and the Poison Prevention Packaging Act

Does the CPSC regulate children’s drugs and do they need to be certified to the new CPSIA standards?

CPSC does not regulate children’s drugs and their accompanying dosing devices such as dosing cups or separate dosing droppers. These products are excluded from the definition of "consumer product" under the Consumer Product Safety Act. However, the CPSC regulates the child-resistant packaging for certain drugs as required by the Poison Prevention Packaging Act (PPPA). If any drug, for children or adults, is required by a CPSC regulation to be in child-resistant packaging, the importer or the domestic party that packages the children’s drug must issue a certificate of conformity with the special packaging requirements of the PPPA.

Posted 12/10/2008.

Does a dosing cup or similar device that accompanies a children’s drug need a certificate of compliance?

No. A dosing cup or similar device that accompanies a children’s drug is not a “children’s product” under the new CPSIA because it is not a consumer product. By definition these items are considered outside the scope of consumer products under the CPSA. However, a dosing dropper that can be used in lieu of a cap as a closure mechanism on a children’s drug would be subject to the PPPA’s special packaging requirements and require certification.

Posted 12/10/2008.

Who must certify that a substance required to be in special packaging is properly packaged?

The importer or the domestic party that packages a PPPA regulated substance in special packaging must issue the general conformity certificate. The child resistance and senior friendly testing data (also known as protocol data) obtained in accordance with the procedures described under 16 C.F.R. 1700.20 may be used by the importer or domestic packager to support its certification. The packager can rely upon this data as the basis for the reasonable testing program. There is no expiration date on these tests and no requirement to retest so long as the tests adequately reflect the current packaging used. (Commission staff does not consider the European tests (ISO 8317, EN 14375, and EN862) to be the equivalent of the tests required by the CPSC regulations.)

Posted 12/10/2008.

Do bulk drugs sold to pharmacies need certificates of conformity?

No. Bulk drugs provided to pharmacies are not subject to the special packaging requirements of the PPPA and therefore no certificate is required.

Posted 12/10/2008.

Do I have to certify my empty vials and caps?

No. The empty container is not subject to the special packaging requirements of the PPPA and does not require certification.

Posted 12/10/2008.

Do clinical trial drugs that go directly to the physician need a certification?

No. Certifications are not required for direct delivery of a clinical trial drug to a physician.

Posted 12/10/2008.

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Section 103: Tracking Labels for Children’s Products

Are tracking labels required on domestically made products or are they only required for imported products?

Tracking labels are required for all children’s products manufactured one year after enactment of the CPSIA (August 14, 2009) regardless of whether they are domestic or imported products.

Will the tracking label requirement be met if premiums are labeled with a date of distribution, a production date and trademark information?

Section 103 of the CPSIA requires that the tracking label provide, "to the extent practicable," marks that will enable the ultimate purchaser to ascertain the manufacturer or private labeler, the location and date of production of the product and cohort information. A label stating only the date of distribution, a production date and trademark information would not satisfy the requirements of section 103. Such a label would lack information identifying the manufacturer or private labeler, the place of production and cohort information.

Could hangtags and adhesive labels be used as tracking labels for textile-type items?

No. The law requires that markings with the specified information be permanent. Hangtags and adhesive labels are not permanent.

The law requires manufacturers to start labeling product and packaging one year after enactment. Does that mean it would affect products manufactured for the 2010 retail season or that items in retail stores would already have to have tracking labels as of August 2009?

The law requires that one year after enactment, or August 14, 2009, manufacturers of children’s products must place permanent marks on their product providing the information specified. Thus, the Commission staff believes that the tracking label requirement applies to children’s products manufactured on or after August 14, 2009.

Will the Commission be providing specifications or guidelines as to size, location and format of the tracking information required by section 103? Or as to the meaning of "to the extent practicable"?

The Commission may issue implementing guidance on these issues. It should be noted, however, that the requirement to provide tracking information is mandatory regardless of whether the Commission provides such guidance.

What information needs to be provided on the product to meet the tracking label requirements of section 103? Does section 103 of the CPSIA require that a manufacturer’s name be present on a tracking label?

Section 103 of the CPSIA provides that the tracking label must contain information that will enable the manufacturer to ascertain the location and date of production of the product and cohort information (including the batch, run number, or other identifying characteristic) and any other information determined by the manufacturer to facilitate ascertaining the specific source of the product by reference to those marks.

Section 103 of the CPSIA further provides that the tracking label must contain information that will enable the ultimate purchaser to ascertain the manufacturer or private labeler, location and date of production of the product, and cohort information (including the batch, run number, or other identifying characteristic.) Thus, section 103 of the CPSIA does require that the tracking label contain information sufficient for the purchaser to ascertain the manufacturer of the product.

Watch the Commission's website for postings regarding further guidance on this issue. The Commission will seek comments from the public during this process.

My company manufactures and imports various beds, as well as night stands, dressers, chest of drawers and mirrors. Are tracking labels required for furniture for children? Are these labels required for each piece of a bed, in one place after the bed is assembled, or in the box the product comes in?

Tracking labels will be required for products if they are primarily intended for children 12 years of age or younger. The label must be on the product (only once) and on the packaging. Section 103 specifies the information that must be provided on the label. This tracking label requirement will take effect for products manufactured on and after August 14, 2009.

Posted 12/04/2008.

I make hand-crafted goods in my home. What do I need to do to be in compliance on August 14, 2009?

The Commission has received a great deal of comment and input from hand-crafters regarding the implementation of Section 103(a). As noted in the Statement of Policy, the Commission anticipates that there will be a period of education after the new requirements go into effect and expects that each manufacturer, large and small, will consider how to apply these requirements to their business.

Hand-crafters should consider the following:

1. What kind of tracking system do you currently use? You do not necessarily have to create a new system of lot, batch or run numbers to identify when you made your products, however your products and their packaging should identify your company in sufficient detail to enable a consumer to reach you so that the required information may be ascertained.
   
   
2. What information can be ascertained about your product? If someone handed you one of your products sold last year, what would you be able to tell them about the materials used? Keeping your receipts and purchase orders will help you to better know the source of your product and its components and when you began using them. Ask your fellow hand crafters if they have any tips or ideas that can help.
   
   
3. How is your product marked? If someone had one of your products sold last year, would they know who to call if there was a problem? Absent any unusual circumstances, your business name should be on your product with sufficient detail to enable a consumer to reach you. Congress recognized that there could be instances where marking a product might not be practicable, such as where the product is very small. Consider the examples outlined in the Statement of Policy where it might not be practicable to mark a product.
   
   
4. How is your packaging marked? Can a retailer of your product see from the packaging (or from the product if the product marking is still fully visible) information that they could use to take just your products from the shelf in the event of a recall?
   
   

Compliance with the new requirements will call on a number of small hand crafters to rethink the way they maintain their records and mark their products.

Posted 07/21/2009.

I make children’s wooden blocks that have twenty in a set. How do I mark these products?

Congress recognized that it might not be practicable to mark every part of a child’s game that has a board and small game pieces. Apply this idea to your product and it may be unnecessary to mark all twenty of the blocks in each of your sets. Depending on the nature of your blocks it might also be reasonable to mark one side of one block. If the blocks come with a storage box or bag, these would be areas to place a mark

Posted 07/21/2009.

I make socks. Am I required to attach labels to each item?

No. The reasonableness of attaching a label to hosiery has already been thoroughly considered in the application of the federal Care Labeling rules. Those rules can be a guide to what is practicable in this case.

Posted 07/21/2009.

Is the information ascertainable if I mark my product and packaging with a code and website address where all the required information can be found?

Yes, provided the name of a manufacturer or private labeler is also identified so a consumer without access to the internet can know whom to contact directly to also obtain the required information.

Posted 07/21/2009.

You didn’t tell us what “to the extent practicable” means in Section 103(a). Is there further insight you might offer?

Section 103(a) mandates distinguishing marks that will enable certain required information to be ascertainable from a product and its packaging. The Statement of Policy says that the Commission expects a manufacturer to depart from the specific requirements of Section 103(a) only for considered and definable reasons. Each manufacturer is ultimately responsible for making a reasonable judgment about what information can be marked on their product and packaging, given the character and type of their product and packaging, and what required information can be ascertainable, given the character and type of their business. When considering the reasonableness of a manufacturer’s decision regarding what information to include in its markings, the Commission intends to look at the individual manufacturer’s situation along with the practices of peer manufacturers.

As questions arise, we may provide more information about the interpretation of this phrase.

Posted 07/21/2009.

Will you post more answers to frequently asked questions?

Additional information in the form of frequently asked questions will be posted as necessary to respond to common issues and concerns that arise.

Posted 07/21/2009.

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Section 104: Standards and Consumer Registration of Durable
Nursery Products

Will infants’ crib bedding, blankets, bath textiles, and apparel fall under the heading of "durable product"?

No. Congress did not define the term "durable," but it is commonly understood to mean able to exist for a long time without significant deterioration. Cloth/textile items are generally not considered to be durable goods. None of the items Congress specified in section 104 as examples of durable products are items made entirely of cloth, rather they are primarily made from rigid materials (e.g., cribs, toddler beds, high chairs, strollers, bath seats).

Are baby slings covered by section 104?

No. Although Congress specified that infant carriers are covered as durable children’s products under section 104, the staff believes that baby slings are not covered but are non-durable cloth products. (Also see the above answer.)

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Section 108: Products Containing Certain Phthalates

What kind of products does the phthalates prohibition apply to?

Three phthalates, DEHP, DBP, and BBP, have been permanently prohibited by Congress in concentration of more than 0.1% in "children’s toys" or "child care articles." A "children’s toy" means a product intended for a child 12 years of age or younger for use when playing, and a "child care article" means a product that a child 3 and younger would use for sleeping, feeding, sucking or teething.

Three additional phthalates, DINP, DIDP, and DnOP, have been prohibited pending further study and review by a group of outside experts and the Commission. This interim prohibition applies to child care articles or toys that can be placed in a child’s mouth or brought to the mouth and kept in the mouth so that it can be sucked or chewed that contains a concentration of more than 0.1% of the above phthalates.

Does the phthalate prohibition apply to inaccessible parts?

The prohibition on phthalates applies to all parts of a children’s toy or child care article as defined in section 108 of the CPSIA. Section 108 does not make an exception or exemption for accessibility for phthalates as is the case for lead in children’s products under section 101.

Does the prohibition on phthalates apply to jewelry?

It depends. If such jewelry is intended for use as a toy for a child 12 years of age or younger, the phthalates prohibition would apply.

Does the prohibition on phthalates apply to sporting goods?

The category of products known as "sporting goods" can include toys but not all sporting goods are toys. Indeed, the ASTM F963 toy safety standard, which becomes a mandatory consumer product safety standard on February 10, 2009, does not define sporting goods equipment to be a toy unless the product is a toy version of sporting goods equipment. However, "children’s toy" in section 108 of the CPSIA is defined broadly as a "consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays." Therefore, any determination as to whether a particular sporting goods product would be a toy as defined under section 108, and therefore, subject to the ban on phthalates, would be made on a case by case basis after consideration of the following factors:

• A statement by the manufacturer about the intended use of the product, including a label on the product if such statement is reasonable.
  
  
• Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by of the ages specified.
  
  
• Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified.
  
  
• The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.
  
  

If the phthalates ban only applies to products manufactured on or after February 10, 2009, how can consumers tell whether products do or do not contain phthalates?

Manufacturers and retailers can label products as complying with the limits in the CPSIA for phthalates regardless of when they were manufactured. The new statute permits products to be labeled as complying with CPSC requirements as long as that representation is accurate. Congress provided for stiff penalties if a company labels a product as compliant when it is not. Retailers can segregate products that meet the phthalates limits in certain areas of the store similar to how many grocery stores have grouped organic products together in one location. Many manufacturers eliminated phthalates from their products and have shared that information with their retailers. DEHP, one of the permanently banned phthalates, apparently has not been used in pacifiers, soft rattles, and teethers since 1999. When in doubt, the consumer should ask the retailer or manufacturer of the product whether it contains phthalates.

Posted 12/04/2008.

Is compliance to the limits of 0.1% for the six banned phthalates based on an analysis for all six regulated phthalates in combination or for each banned phthalate individually?

The 0.1% limit for the six banned phthalates applies to each individual phthalate, not the total amount of these phthalates in the product.

Posted 12/04/2008.

How do you determine whether a product is a children’s toy for purposes of compliance with the phthalate limits?

Section 108 limits the amount of phthalates in children’s toys and certain other child care articles. A children’s toy is a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays. Any determination as to whether a particular product is designed and intended for use by a child 12 years of age or younger, would be made on a case by case basis after consideration of the following factors:

• A statement by the manufacturer about the intended use of the product, including a label on the product if such statement is reasonable.
  
  
• Whether the product is represented in its packaging, display, promotion or advertising as appropriate for use by the ages specified.
  
  
• Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified.
  
  
• The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.
  
  

A manufacturer must apply these factors their products and then consider whether it is “for use by the child when the child plays” to determine whether a product meets the definition of a children’s toy. The use of the product by the child for play is a fundamental aspect of such a determination. The Commission will be evaluating this using staff from Health Sciences, Human Factors, and Compliance, and hopes to provide additional guidance on this issue. In the interim, the Commission staff plans to use the definition of toy in the ASTM F963-07 toy standard for guidance.

Posted 12/04/2008.

How do you determine whether a product is a child care article for purposes of compliance with the phthalates limits?

A child care article is a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething. By way of example, a pacifier/teether would be an item that would help a child with sucking or teething; a bib would facilitate feeding; a crib mattress would facilitate sleeping as would pajamas and crib sheets.

Posted 12/04/2008.

How do I know whether a toy may be placed in a child’s mouth?

Congress stated that the interim ban on DINP, DIDP, and DnOP applies only to children’s toys that can be placed in a child’s mouth. It provided the following definition of when a toy can be placed in a child’s mouth. “A toy can be placed in a child’s mouth if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the toy can only be licked, it is not able to be placed in the mouth. By definition, if a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.” Thus, any toy in a baby’s hand that can make it into the baby’s mouth to be sucked on, or chewed, is subject to the interim ban.

Posted 12/04/2008.

Does the packaging of a product have to comply with the phthalates ban? Does it matter if the packaging is normally discarded (e.g. poly bag and blister packaging) or intended to be reused (e.g., heavy gauge reusable bag with zipper closure to store a set of blocks)?

The CPSIA defines children’s toys as consumer products designed or intended for use by children 12 and under when playing. Packaging is generally not intended for use by children when they play, given that most packaging is discarded and is not used or played with as a children’s toy or child care article. However, if the packaging is intended to be reused, or used in conjunction with a child care article or with a children’s toy while playing, such as a heavy gauge reusable bag used to hold blocks, it would be subject to the phthalates ban.

Posted 12/04/2008.

If a cosmetic material is used in a toy set which has play value would it be classified as a part of the toy and therefore subject to the ban on phthalates?

Yes. If a cosmetic material is included in a toy set it is required to meet the requirements of the phthalates ban. However, cosmetics in general when not packaged with a toy, are not covered by the section 108 prohibitions and fall under the jurisdiction of the Food and Drug Administration.

Posted 12/04/2008.

May a manufacturer use a phthalate that is not banned or an alternative plasticizer in a children’s toy or child care article.

The CPSIA has permanently banned DEHP, DBP, and BBP, while DINP, DIDP and DnOP are banned on an interim basis. However, an unbanned phthalate or an alternative plasticizer that is not one of the above banned phthalates may be used in a children’s toy or child care article. During the upcoming study of phthalates required by the legislation, an assessment of the interim banned phthalates DINP, DIDP and DnOP will be conducted, to include an assessment of the full range of other phthalates and phthalate alternatives, for potential health effects.

Manufacturers are still responsible for ensuring that children’s products are not considered “hazardous” under the general requirements of the Federal Hazardous Substances Act (FHSA). It is the manufacturer’s obligation to ensure that any alternative plasticizer used be adequately tested such that the manufacturer is confident it does not pose a risk of injury under normal use or reasonably foreseeable misuse. Children’s products that are hazardous or contain a hazardous substance are automatically banned. The Commission has issued chronic hazard guidelines to assist manufacturers in complying with the requirements of the FHSA. (http://cpsc.gov/BUSINFO/chronic.pdf).

Posted 12/04/2008.

Do the phthalate limits apply to children’s shoes or socks?

Shoes and socks are not considered to be children’s toys or child care articles. See the Office of the General Counsel Advisory opinion (http://www.cpsc.gov/library/foia/advisory/318.pdf).

Posted 12/04/2008.

Are personal flotation devices, such as life jackets, subject to the CPSIA? Specifically, are such products that are made for, and used by, children considered to be children’s products under the CPSIA?

No. Life jackets are excluded from the definition of “consumer product” by the Consumer Product Safety Act, 15 U.S.C. § 2052(a)(1)(G). They are regulated by the U.S. Coast Guard. The CPSIA did not change this. A “children’s product” is defined by the CPSIA as “a consumer product designed or intended primarily for children 12 years of age or younger.” Because life jackets are not consumer products, they would not be considered “children’s products” or “children’s toys” under the CPSIA and would not be subject to CPSIA requirements applicable to children’s products. However, toy versions of life jackets or flotation devices like “water wings” do fall within the CPSC’s jurisdiction.

Posted 12/04/2008.

Would such items as pool toys and beach balls be considered children’s toys under the CPSIA?

Pool toys, beach balls, blow up rafts, and inner tubes designed or intended for children 12 years of age or younger would be considered children’s toys. Those objects are used by children when playing in a swimming pool or at the beach. Therefore, they would be required to comply with the section 108 limits on specified phthalates.

Posted 12/04/2008.

What certifications are required for children’s toys and child care articles subject to the phthalates ban?

Children’s toys and child care articles manufactured on or after February 10, 2009, will need a general conformity certification based on a “test of each product or a reasonable testing program.” Starting in September 2009, children’s toys and child care articles will have to be certified based on third-party testing of the product by accredited third-party laboratories. The Commission must post its procedures for accrediting labs to test for phthalates in June 2009.

Posted 12/04/2008.

If you have a “children’s toy” or ‘child care article” with possible banned phthalates, do you have to issue a general conformity certificate on November 12, 2008, even though the phthalate ban is not effective?

No. The phthalates ban for children’s toys and child care articles does not go into effect until February 10, 2009. As stated above, children’s toys and child care articles manufactured on or after February 10, 2009 will require a general conformity certification based on a “test of each product or a reasonable testing program.” Starting in September 2009, children’s toys and child care articles will have to be certified based on third-party testing of the product by accredited third-party laboratories.

Posted 12/04/2008.

How will CPSC select members of the Chronic Hazard Advisory Panel (CHAP), and ensure that the members are independent and objective?

The legislation requires the Commission to form a Chronic Hazard Advisory Panel (CHAP) to study the health effects of phthalates on children. Requirements for the selection of CHAP members are described in the Consumer Product Safety Act (CPSA). The Commission will select 7 CHAP members from a list of at least 21 independent scientists nominated by the National Academy of Sciences. Scientists who are associated with manufacturers of products or chemicals covered by the CHAP and scientists employed by the federal government (except employees of the National Institutes of Health, National Toxicology Program, and the National Center for Toxicological Research) are not eligible to be nominated. Panel members will be selected on the basis of their qualifications. Once appointed, the Panel members will elect a Chairman and Vice Chairman.

Posted 12/04/2008.

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Section 231

Do the new standards in the CPSIA, such as the new limits on lead-containing paint and lead content, phthalates and the like, preempt state laws that address the same risk of injury?

The new lead limits for lead paint and lead content preempt state law as do the new provisions on phthalates and ATVs. The provision mandating the voluntary toy safety standard ASTM F963-07 as a mandatory consumer product safety standard is also preemptive although there Congress has provided a mechanism to grandfather in certain existing state laws on toy safety. We will be addressing which of those state laws that are designed to deal with the same risk of injury as the ASTM F963-07 toy safety standard will remain in effect. However, in order to qualify for an exemption from preemption from a toy safety standard under ASTM F963-07, the state toy safety laws must have been in effect on August 13, 2008 and states had to submit them to CPSC by November 12, 2008.

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Section 232: All-Terrain Vehicle Standard

When does the mandatory standard go into effect?

The current voluntary standard will take effect as a mandatory standard on April 13, 2009. A notice was published in the Federal Register November 14, 2008 incorporating the ANSI/SVIA 1-2007 standard by reference, 73 Fed. Reg. 67385 (http://www.cpsc.gov/businfo/frnotices/fr09/atvfinal.pdf) . The law states that “after the standard takes effect, it shall be unlawful for any manufacturer or distributor to import into or distribute in commerce in the United States any new assembled or unassembled all-terrain vehicle” unless it complies with the ATV standard and is subject to, and complies with, an action plan filed with the Commission. Posted 11/19/2008.

When is the deadline for manufacturers or distributors of ATVs to have an action plan on file with the Commission?

As of April 13, 2009 it will be unlawful for an ATV manufacturer or distributor to distribute or import an ATV in the United States unless the ATV is subject to an action plan on file with the Commission and the manufacturer/distributor complies with all provisions of the action plan (as well as all provisions of the ANSI/SVIA 1-2007 standard for ATVs). Action plans submitted after the CPSIA was enacted (i.e., after August 14, 2008) must be approved by the Commission. Therefore, action plans should be submitted as soon as possible to allow the Commission time to review them before April 13, 2009. Posted 11/19/2008.

Are ATVs subject to the requirements for general conformity certification under section 102(a)(1)?

Yes. Section 102(a)(1) requires every manufacturer of a product that is subject to a consumer product safety standard to issue a certificate certifying that the product meets that standard (as well as others that are applicable). The CPSIA directs the Commission to publish the ANSI/SVIA-2007 standard for four wheel ATVs as a consumer product safety standard. Thus, once the standard takes effect (150 days after publication in the Federal Register) the products that are subject to the ATV standard must also be certified to it (and any other standards applicable to those products)

Are youth ATVs subject to the third party testing requirements of section 102(a)(2)? And if so, when?

: Section 102(a)(2) requires third party testing for children’s products that are subject to a children’s product safety rule. A children’s product is a consumer product designed or intended primarily for a child 12 years of age or younger (see section 232(a)). Thus, youth ATVs intended primarily for children 12 years of age or younger will need to comply with the third party testing requirements of section 102(a)(2). This will require third party testing for compliance to the new ATV standard. A manufacturer’s certification based on that testing requirement will be required 90 days after the Commission publishes accreditation requirements for testing laboratories that will test conformity to the ATV standard.