The U.S. Consumer Product Safety Commission (CPSC) has approved High-Definition X-Ray Fluorescence (HDXRF) technology for the substrate testing of lead in children’s products using the test method ASTM F2853-10. HDXRF technology, used to detect regulated elements, had previously been approved by the CPSC for testing of lead in paint and other surface coatings of children’s products.
This new action by the CPSC expands the use of HDXRF for third-party testing to support product certification and clears the way for its use in “production testing” under the new CPSC Testing and Certification Rule, which became effective February 8, 2013. HDXRF offers the additional benefits of taking coating and substrate measurements simultaneously and non-destructively, reducing testing time and cost.
“The CSPC’s approval of HDXRF for lead in substrate testing means that manufacturers, importers, retailers and laboratories now have a complete, precise, and reliable alternative to traditional wet chemistry,” said Satbir Nayar, director of sales and marketing for consumer products of XOS, a developer of the HDXRF technique.
The detailed new CPSC regulation, called the 1112 Rule, approving HDXRF for lead in substrate testing and restating the agency’s April 2011 approval of HDXRF for lead in paint testing, can be accessed atwww.cpsc.gov.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2013-02-25 15:36:312013-02-25 15:36:31CPSC Approves New Lead Testing Method in Substrates of Children’s Products
The Fiscal Year (FY) 2013 Operating Budget for the Consumer Product Safety Commission (CPSC) has some items that are likely to make either the biggest or most news in the coming year. They are the CPSC’s compliance, import surveillance and hazard identification activity.
Compliance: Enforcement activities under the rulemaking of the Consumer Product Safety Improvement Act of 2008 (CPSIA) will be stepped up. These compliance efforts will include; data analysis, investigations and assessing the level of compliance with new regulations. The 2013 budget targets compliance and enforcement programs for;
CPSIA-mandated requirements for cribs, toddler beds, play yards, bed rails, strollers, and swings
Federal Hazardous Substances Act regulations for toys, bath seats, rattles, pacifiers and infant pillows
Import Surveillance: With the passage of the CPSIA, the CPSC was directed to create an International Trade Data System/Risk Assessment Methodology (ITDS/RAM) to help identify products entering into the U.S. that have a high probability for violation of consumer product safety rules and regulations. Based on this the CPSC launched a “proof-of-concept” pilot program that uses data collected at the port by U.S. Customs and Border Protection’s (CBP) International Trade Data System, and integrates the data with CPSC surveillance systems to analyze incoming imports. Imports which are identified as “high risk” are targeted based on predetermined rule sets and stopped at the port for inspection. In 2013, this pilot program is expected to expand to 15 major U.S. ports. The CPSC has established four areas for measuring successes with the program;
Improve working effectiveness with CBP to harness existing federal port resources in the interdiction of noncompliant consumer product imports
Protect U.S. intellectual property, consistent with the CPSC’s safety mission
The CPSC is expected to continue its collaboration with the CBP to implement national operations designed to optimize the federal government’s response to product’s that are imported into the U.S. that may put consumers at risk.
Another indication of this collaboration is the rewrite of 16 CFR 1110 which lays out the requirements for manufacturers/importers of record with regard to certificates of conformity (children’s and non-children’s products). Currently there is not a requirement for children’s product importers to file a certificate with the CBP or CPSC prior to the product entering into the U.S. The importer would only have to have the certificate “available upon request” to either the CBP or the CPSC. The proposed change would require the importer to electronically file a children’s product certificate with the CBP prior to the product entering into the U.S. as part of their importation documents.
Hazard Identification: In 2013, the CPSC will prepare draft final rules for the following products;
Bassinets
Bassinet attachments to play yards
Bedside sleepers
Handheld carriers
Soft infant carriers
Strollers
The CPSC will also prepare draft final rules for; rare earth magnet sets, mattresses and toy guns with caps. In addition draft rules will be prepared for infant slings, infant inclined sleep products, revisions to the FHSA definition of “strong sensitizer” and a petition for crib bumpers will be evaluated.
Voluntary Standards: The following voluntary standards are expected to have the most activity in 2013;
Baby monitors
Bassinets/cradles
Bath seats (infant)
Batteries
Bed rails
Bunk beds
Beds (toddler)
Bedside sleepers
Bicycles
Booster seats
High chairs
Youth chairs
Changing tables
Children’s metal jewelry
Full-size cribs
Non-full-size cribs/play yards
Infant bedding/accessories
Infant bouncers
Infant carriers (frame)
Infant carriers (handheld)
Infant carriers (soft)
Infant gates
Infant recline sleep products
Infant slings
Infant swings
Infant tubs
Infant walkers
Inflatable play devices
Phthalates
Playground equipment (for children under 2 years)
Playground equipment (home)
Strollers
Toys
Trampolines
Strategic Goals for Commitment to Prevention include;
Office
Performance Measurement
FY2013 Target
Hazard
Number of Voluntary standards activities supported or monitored by CPSC Staff
69
Hazard
Number of candidates for rulemaking prepared for Commission consideration
30
Compliance
Number of establishment inspections conducted by Field Staff
1,000
Compliance
Percentage of products screened by CPSC Field Staff resulting in violations
Baseline to be determined
Hazard
Number of items/component parts tested for specific standards and regulations
36,000
Import
Number of import examinations
13,000
Import
Sample yield per 100 import entries
26
Import
Establish a robust ITDS/RAM rule set to target intellectual property violations where a health and safety hazard is suspected in consumer product imports
To be determined
Compliance
Total number of products screened by CPSC Staff
Baseline to be determined
Compliance
Number of consumer products screened by CPSC Field Staff through Internet surveillance activities
Baseline to be determined
Additional Items: The Commission has added the following items to the FY 2013 budget which is targeted at reducing the testing burden by manufacturers and/or importers of record for children’s products;
Determinations Regarding Heavy Metals – the Commission would like to undertake the process of determining if there are materials that would qualify for exemption to the heavy metals specification found in section 4.3.5 of ASTM F963-11. The materials cannot be found to contain higher than allowed concentrations of the eight heavy metals.
Determinations Regarding Phthalates – the Commission would like to undertake the process of determining if there are materials that do not, and will not, contain prohibited phthalates, and would therefore be exempt from third party testing
Determination Regarding Adhesives in Manufactured Woods – the Commission would like to undertake the process of determining if there are any adhesives used in manufactured wood that can be determined not to contain lead in amounts above 100 ppm.
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In this post, please find a list of recent CPSC news, regulatory updates, and other activities that may be of interest to you.
Periodic Testing Requirements
On this Friday, February 8, 2013, a new regulation that requires the periodic testing of continuing production of children’s products becomes effective. The regulation is 16 CFR part 1107. We have posted some new information and FAQs at the following Web page:
Please note that we are currently reorganizing the testing and certification pages during the transition to a new CPSC.gov website. Further updates, information, and FAQs about third party testing and certification will be coming soon.
CPSC.gov Website
You may have noticed that CPSC recently redesigned its website to provide a better user experience for stakeholders. With the migration to the new website, some users have reported difficulty finding certain resources. We appreciate your patience as we fix the new website’s nits and ask you to report problems at: http://www.cpsc.gov/cgibin/epifeedback.aspx.
Upcoming Presentations
New York, NY – Monday, February 11, 2013: General CPSIA Presentation
26 Federal Plaza, Downtown Manhattan, Conference Room A, 6th Floor, 2 pm
I will be speaking to any interested small business in the metropolitan New York City area this coming Monday. The presentation will be an overview of U.S. regulatory requirements for consumer products (including children’s products) and will also explain the requirements and benefits of registering as a small batch manufacturer with CPSC. The presentation will include a discussion of third party testing requirements, including periodic testing requirements.
The presentation is free and open to the public. Advance registration is requested (but not required) to ensure adequate seating. The presentation will take place in Conference Room A at the Federal Plaza Conference Center located at 26 Federal Plaza, which is at the southeast corner of Worth Street and Broadway in downtown Manhattan. Please allow approximately 30 minutes to get through security and arrive to the 6th floor. There also is a café on the 6th floor. You may contact me at ncohen@cpsc.gov with any questions and to RSVP.
New York, NY – Tuesday, February 12, 2013: Presentation on Third Party Testing
Jakob K. Javits Convention Center, Room 1E19, 10 am
I will be speaking to attendees at the New York International Toy Fair this coming Tuesday. The presentation was requested by the Toy Industry Association and addresses the U.S. third party testing requirements for toy manufacturers, including periodic testing requirements. CPSC Chairman Inez Tenenbaum will be the keynote speaker at 9 am.
Washington, DC – Thursday, February 28, 2013: Panel on Third Party Testing
Hyatt Regency Crystal City at Reagan National Airport, Room TBD, 1:45 pm; 3:30 pm
I will be moderating a panel for attendees on Day 3 (“CPSC Day”) of the International Consumer Product Health and Safety Organization (ICPHSO) conference. The panel will address third party testing, including the periodic testing requirements. More information, including the list of CPSC panelists, is available here: http://www.icphso.org/conference/2013annual/agenda.html.
Regulatory Update:
Newly proposed regulations are open for public comment and recently enacted regulations are set to go into effect. If you have never commented on a rule before, you can learn more about the rulemaking process and how you can add your comments to the proposed rule before it is finalized. Your comments are vital to ensuring that the Commission has as much information as possible as the Commissioners consider whether to finalize proposed rules into law.
New Regulations: Effective Dates for Compliance
Cribs – The crib standards went into effect for all new cribs sold on or after June 28, 2011. Child care providers, family child care homes, places of public accommodation (e.g. hotels), and crib rental companies were given until December 28, 2012 to ensure that their cribs comply with the new regulations. Please see our Crib Information Center for more information tailored to child care providers to enable you to determine if your cribs comply: www.cpsc.gov/cribs.
Play Yards –The new play yard regulation was published on August 29, 2012 and has an effective date of February 28, 2013. It is codified at 16 CFR Part 1221.
Infant Swings –The new infant swing regulation was published on November 7, 2012 and has an effective date of May 7, 2013. It is codified at 16 CFR Part 1223.
Reducing Third Party Testing Burdens – In October, the Commission voted to direct the CPSC staff to study possible options for reducing the burdens related to third party testing. Such studies would be subject to staff resource availability. The results and the Commissioners’ statements are available at: http://www.cpsc.gov/PageFiles/130209/3rdparty.pdf.
In January, the Commission voted to direct the staff to draft “Requests for Information” (RFIs) on four possible burden reduction options to be included in CPSC’s 2013 operating plan. The four areas about which the Commission will gather information concern: heavy metal content in certain materials, phthalates in certain materials, and lead content in synthetic food additives and adhesives used in manufactured woods. See the Commission’s action at: http://www.cpsc.gov/PageFiles/139100/2013operatingplan.pdf.
Representative Samples – On December 5, 2012, the Commission finalized its rule on ensuring the use of representative samples used in third party testing. The rule also has an effective date of February 8, 2013.You can learn more here.
Open For Public Comment (Selected items)
Hand-Held Infant Carriers – The Commission voted to publish a draft final rule for a new Safety Standard for Hand-Held Infant Carriers. The proposed rule was published December 10, 2012 and public comments are due by 11:59 pm on February 25, 2013. You can watch the staff presentation in archived format here and comment here.
Bedside Sleepers – After a recent staff briefing, the Commission voted to publish a draft final rule for a new Safety Standard for Bedside Sleepers. The proposed rule was published December 10, 2012 and public comments are due by 11:59 pm on February 25, 2013. You can watch the staff presentation in archived format here and comment here.
Comment Period Recently Closed
Bassinets and Cradles – The public comment period for a Supplemental Notice of Proposed Rulemaking for a Safety Standard for Bassinets and Cradles recently closed on January 2, 2013. The Commission staff is currently evaluating the comments received.
Make sure to get your products into compliance before the new regulations become effective, which has generally been about six months after the final regulations are published.
Small Batch Manufacturers:
PLEASE NOTE that if you were a registered small batch manufacturer with the U.S. Consumer Product Safety Commission (CPSC) for calendar year 2012 and you wish to continue in this status, you must register for calendar year 2013. Registration must be submitted annually. Registration is ongoing, and you may register at any time during this calendar year – through December 2013.
If you wish to register as a small batch manufacturer for calendar year 2013, your registration must be based upon the total number of product units sold and the total gross revenues from the sales of all consumer products in the previous calendar year – January 1, 2012 through December 31, 2012. If you meet these requirements, you may now register for calendar year 2013 by logging into your user account in the Business Portal at: www.SaferProducts.gov.
When you log in to your account at: www.SaferProducts.gov and you click the “Small Batch Manufacturer” tab with your cursor, you will be asked to attest that your company satisfies the criteria to register; the criteria are the same as last year and have only been updated to account for your company’s sales in calendar year 2012. Once you are certain that you can attest to the truth and accuracy of the statements for your sales in calendar year 2012, you may check the boxes and submit your registration. Within the next day or so, you will receive a confirmation e-mail message with your new, unique Small Batch Manufacturer Registration Number for 2013. *Please save that e-mail message for your reference.* If you do not yet know whether you will qualify as a small batch manufacturer based on sales through December 2012, please wait to register until you have full information regarding your sales numbers. Registration is ongoing, and you may register at any time during this calendar year – through December 2013.
Please note that when you log in to your account after your registration for calendar year 2013 is accepted, your Business Portal account will display your unique Small Batch Manufacturer Registration Number for both calendar years 2012 and 2013. Please use the appropriate number (based on the date of your product’s manufacture or final assembly) in drafting your Children’s Product Certificate.
If you have any questions or require assistance with the registration process, please e-mail: clearinghouse@cpsc.gov.
If you have any questions about how registration as a small batch manufacturer with the CPSC affects your obligations to test and certify your products as compliant with applicable consumer product safety rules or compliance with other CPSC rules, regulations, standards, or bans, please review the program information at: www.cpsc.gov/smallbatch. If you need further assistance, please e-mail me at: ncohen@cpsc.gov.
As always, please let me know if you have additional questions or concerns. We post updates – especially about regulation comment periods – frequently to our Twitter account at www.twitter.com/CPSCSmallBiz.
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2013-02-07 12:07:022013-02-07 12:07:02CPSC Updates from Small Business Ombudsman
In an advisory issued by the law firm of Arnold & Porter LLP, they highlight the new testing and certification rules coming into effect February 8, 2013 for manufacturers and importers of children’s products. The two rules; 16 C.F.R. Part 1109 (effective December 2011), which permits certification of the product by relying on component part testing or another party’s finished product testing and 16 C.F.R. Part 1107, which outlines the additional requirements concerning certification and ongoing testing and labeling of children’s products. They summarized the key provisions of these regulations which have been discussed previously in this blog.
Third Party Testing for Certification (§1107.20) – the initial certification must be based on a “sufficient number of samples” that are “identical in all material respects” to a third party laboratory that is accredited by the CPSC to do the testing for initial product certification. If any of the samples submitted fails certification testing then the failure must be investigated by the manufacturer/importer of record and corrective action must be taken and documented before additional samples are re-submitted for testing and certification.
Periodic Testing (§1107.21) – after the initial certification of the product, periodic testing of the product must continue as long as it is in production. The test plan selected by the manufacturer/importer of record can either be; periodic testing plan (at least once per year), production testing plan (at least once every two years) or ISO 17025 testing plan (at least once every three years). The type of testing plan chosen will depend on several factors and must be done for each manufacturing site.
Material Change (§1107.23) – any change in a children’s product after initial certification and before the test plan testing time, that would affect the products ability to continue to be compliant, must be re-tested. A material change is defined as; change in manufacturing process or facility, change in souring of component parts or suppliers.
Undue Influence Policy (§1107.24) – every manufacturer/importer of record must establish a undue influence policy with regard to third party laboratories which should include; a written policy statement from company officials, training for all appropriate employees, attestation of training, means of immediately notifying the CPSC of any attempts of undue influence or attempts to hide undue influence and retraining of employees if undue influence requirements should change.
Recordkeeping (§1107.26) – records on all children’s products must be maintained by the manufacturer/importer of record for a period of five (5) years and must be made available to the CPSC upon request. These records should include; children’s product certificate per product per manufacturing site, periodic testing records (including the test plan and test results within those test plans), representative samples chosen and the methodology for the representative samples, documentation of all material changes by product by manufacturing site and undue influence training and materials.
Labeling of Consumer Products to Indicate Compliance (§1107.30) – once a children’s product has met all the applicable rules, bans and standards that would apply to the product, the manufacturer/importer of record can label their product with “Meets CPSC Safety Requirements”
Reliance on Component Part Testing or Another Party’s Testing or Certification (§1109.5) – a manufacturer/importer of record can rely (with conditions) on testing and certification supplied by a component part supplier or a finished product supplier (manufacturer) for the purposes of final product certification. The CPSC expects the manufacturer/importer of record to exercise “due care” when accepting this testing or certification. Due care (as pointed out in the alert) could include; conducting a reasonable review of the other party’s certification or test reports and addressing any discrepancies or other concern over the validity, confirming that the testing labs have been accredited by the CPSC, asking other third party labs to confirm the authenticity of the test reports, inspecting or auditing factories to ensure that good manufacturing practices have been carried out, proper sampling procedures and the periodic test plan are being followed and that the necessary records are being kept, or submitting samples to another third party lab to verify compliance of the product. The alert goes on to point out that certain documentation must be received from the component supplier or finished product supplier (manufacturer) before the manufacturer/importer of record can rely on these test reports or certifications. They include;
Identification of a lot or batch number to identify the component part or finished product that the testing or certification applies to
Identification of the testing methods and sampling protocols used
Attestation by the third party lab that performed the testing
Records to support the traceability
Attestation by component supplier or finished product supplier (manufacturer) and third party lab that while the component part or finished product was in their care, custody and control they exercised due care to ensure compliance with test integrity requirements.
The challenges pointed out in the alert to comply with all the above regulations as it pertains to component part or finished product certification and testing really comes down to; does a manufacturer/importer of record have enough control over the manufacturing process comply with the record keeping of these two rules? There are really only two paths that an importer or finished product manufacturer can take for compliance; either do all the testing on the product themselves or rely on the foreign manufacturer (or component part supplier) testing and certification of the product.
Questions to Ask?
Can I obtain all of the documentation and develop/implement all the necessary procedures to show that we have exercised “due care” when relying on other parties testing and certification?
What steps do we need to take to “reasonably” know when there has been a material change in the product or the components of the product?
Should we test the product (or component parts) from each purchase order/shipment to ensure that the product (or component part) are still representative of those in distribution and that no material change has been made?
https://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpg00BillJhttps://jacobysolutions.com/wp-content/uploads/2023/08/Jacobysolutions-300x150.jpgBillJ2013-02-01 14:25:212013-02-01 14:25:21New Year, New Rules: Consumer Product Contacts Safety Commission (CPSC) Safety Testing and Certification Rules Taking Effect for Children’s Products
