ASTM Toy Safety Standard F963-11 Is Issued

Updates Address Heavy Metals, Compositing, Bath Toy Projections and More

PR Newswire

WEST CONSHOHOCKEN, Pa., Dec. 16, 2011 /PRNewswire/ — As part of its continuing efforts to proactively address potential toy safety issues, ASTM International Committee F15 on Consumer Products has approved revisions to ASTM F963, Consumer Safety Specification for Toy Safety. Changes made to the standard include revisions to the section on heavy metals, the introduction of compositing procedures, and new safety requirements and technical guidance for bath toy projections, acoustics and other potential safety hazards in toys.

ASTM F963, under the jurisdiction of Subcommittee F15.22 on Toy Safety, includes guidelines and test methods to prevent injuries from choking, sharp edges and other potential hazards. The standard is reviewed and updated on a regular basis by the subcommittee, which includes technical experts from academia, consumer groups, industry and government.

“These revisions build on the already comprehensive F963 standard by proactively addressing areas where potential risks or opportunities for harmonization have been identified,” says Joan Lawrence, F15.22 chairman and vice president, standards and government affairs for the Toy Industry Association (TIA).

Revisions now approved for F963 include the following:

  • Heavy Metals — Limits for heavy metals in toy substrates have been added to the existing surface coating requirements. A soluble approach for determination of heavy elements in toys and toy components has been maintained as this has been demonstrated to be more closely correlated than total content with the amount of element which is bioavailable, and therefore with risk of toxicity.
  • Compositing Procedure for Total Heavy Metal Analysis — Revisions outline detailed procedures for accomplishing this end by specifying the conditions under which compositing is allowable, when a composite result may be relied upon without further testing, and when testing of individual samples must subsequently be performed.
  • Bath Toy Projections — Revisions are intended to address the potential hazards that may be presented by vertical, or nearly vertical, rigid projections on bath toys. This requirement is intended to minimize possible puncture or other hazards to the skin that might be caused if a child were to fall on a rigid projection.
  • Among other revised areas of the standard are sections on jaw entrapment; toys with spherical ends; stability of ride on toys; requirements for squeeze toys attached to rings; use of cords, straps and elastics; packaging film; and yo-yo tether balls.

As part of the landmark Consumer Product Safety Improvement Act (CPSIA) of 2008, the U.S. Congress endorsed both the F963 standard and the process under which it is developed and continually reviewed and revised. If the CPSC agrees that the revisions improve safety, ASTM F963-11 will replace the 2008 version of the standard as federal law in 180 days.  For more information about the CPSIA and compliance with this law, visit the CPSC Web site, www.cpsc.gov.

ASTM International standards are available for purchase from Customer Service (phone: 610-832-9585; service@astm.org) or at www.astm.org.

ASTM International welcomes and encourages participation in the development of its standards. ASTM’s open consensus process, using advanced Internet-based standards development tools, ensures worldwide access for all interested individuals. For more information on becoming an ASTM member, please contact Leonard Morrissey, ASTM International (phone: 610-832-9719; lmorriss@astm.org).

For technical Information, contact: Joan Lawrence, Toy Industry Association, New York, N.Y. (phone: 212-675-1141; safety@toyassociation.org).

Follow ASTM Consumer Products news on Twitter @ASTMProductsRec.

Established in 1898, ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions around the globe.

View this release on the ASTM Web site at www.astmnewsroom.org.

ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org

Read more: http://www.digitaljournal.com/pr/526007#ixzz1gixEdGE9

Record Keeping and Labeling Requirements for Children’s Products

December 9, 2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 5

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the fifth and final part of this article we will look at the requirements for manufacturers/importers under the recordkeeping part of the rule.

Recordkeeping

A manufacturer/importer of a children’s product must maintain the following records;

  • a copy of the Children’s Product Certificate (General Certificate of Conformity) for each product.  The description on the certificate must clearly distinguish and define the product so that it is identifiable from others that the manufacturer/importer may have
  • records of each third party certification tests.  The manufacturer/importer must have separate certification tests records for each manufacturing site even for the same product.  The manufacturer/importer cannot assume that units of the same product manufactured in more than one location are identical in all material respects.  Differences in power quality, climate, personnel, and factory equipment could materially affect the manufacture of the product.
  • records of one of the following for periodic tests of a children’s products
    • periodic test plan and periodic test results (every year)
    • production testing plan, production test results and periodic test results (every two years)
    • testing results of tests conducted by a ISO/IEC 17025:2005(E) accredited laboratory and periodic test results (every three years)
    • material change records describing all;
      • product design changes
      • manufacturing process changes
      • sourcing of component part changes
      • certification tests and their values
    • undue influence training records including;
      • training materials
      • training records of all employees trained
      • attestations of these employees for training

Manufacturers/importers must maintain the records specified for five years.  These records must be made available to the CPSC upon request either in hard copy or electronic format, such as through an internet web site.  These records can be maintained in languages other than English if they can be;

  • Provided immediately by the manufacturer/importer to the CPSC
  • Translated accurately into English by the manufacturer/importer within 48 hours of the request by the CPSC (or longer if negotiated with the CPSC staff

Product Labeling

This portion of the ruling outlines the program by which a manufacturer/importer of record may label a consumer product as complying with the certification requirements of section 14 of the CPSA.  The labeling program is not mandatory and can be used at the discretion of the manufacturer/importer who must determine for themselves the cost versus benefit of the program.  The label specifications are designed to avoid giving consumers the false impression that the product is neither a CPSC tested, endorsed or approved product.  It also prohibits manufacturers/importers from implying through the manipulation of the font type, size or other means that the CPSC has tested, endorsed or approved the product.

The label to be printed must be printed in a bold typeface using an Arial font of no less than 12 points, be visible and legible and state:  “Meets CPSC Safety Requirements”  Depending on the product’s characteristics, such as size, surface finish or the presence of a smooth or flat surface, the CPSC has allowed with the Product Labeling rule to give manufacturers/imports flexibility in implementing this rule.  The final rule does not allow for a symbol or a mark to show compliance as it might be misunderstood as a CPSC certification mark or endorsement of the product.  The labeling can appear on the packaging, within the informational literature found with the product, on the product itself or all three.

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your recordkeeping  and labeling process to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.

Undue Influence – Establishing Your Company’s Policy

December 8, 2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 4

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the fourth part of this article we will look at the requirements for manufacturers/importers under the Undue Influence part of the rule.

Undue Influence

Each domestic manufacturer or the importer of a children’s product must establish procedures to safeguard against the exercise of undue influence on a CPSC accredited laboratory that could undermine the integrity of laboratory test data.  While the importer is not directly responsible for the training of employees of foreign manufacturers on this matter, it does not absolve the importer of its duty to exercise due care when relying on test reports provided by the manufacturer from a CPSC accredited laboratory.  The importer who issues a General Certificate of Conformity on a product that is based on test reports from a CPSC accredited laboratory over whom undue influence has been exercised provides a basis for the CPSC to deem the certificate invalid.  The CPSC will hold the final product certifier (manufacturer/importer) responsible for exercising due care that component part or finished product manufacturers or suppliers have not exercised undue influence over CPSC certified laboratories.

At a minimum these procedures must include;

  • Training for every appropriate staff member on the safeguards by the manufacturer/importer designed to prevent undue influence on CPSC accredited laboratories along with a signed training statement from each staff member
  • Written policy statement from company officials that the exercise of undue influence is not acceptable
  • Procedure for retraining based on any substantive changes to § 1107.24
  • Procedure to notify the CPSC immediately of any attempt by the manufacturer/importer to hide or exert undue influence over test results
  • Procedure/mechanism for employees of the manufacturer/importer to report confidentially to the CPSC any allegations of undue influence

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your company policies and include an Undue Influence component to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.

Defining a Material Change after Product Certification

December 7,2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 3 Material Change

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the third part of this article we will look at the requirements for manufacturers/importers under the Material Change part of the rule.

Material Change

After the initial certification of a product, a “material change” in the product is a change that “could affect the product’s ability to comply with applicable rules, standards or regulations.”  This could occur based on a change in product design, manufacturing process or the sourcing of component parts where the manufacturer/importer knows or should know could affect the products ability to comply with all applicable children’s product safety rules.  At this point the manufacturer/importer must submit sufficient samples of the product to a CPSC accredited laboratory to test for compliance.

A manufacturer/importer whose product has undergone a material change cannot issue a new Children’s Product Certificate until  this testing is done.  Changes that cause a children’s product safety rule to no longer apply to a children’s product are not considered material changes.  The extent of testing needed depends on the extent of the material change.

For example, if the children’s product was a cotton sweater with metal buttons that were certified under the lead limits of Section 101 of the CPSIA and were changed to wooden buttons would this be classified as a material change?  Yes and No, changing to wooden buttons would eliminate the need to show continued compliance for lead limits under Section 101 of the CPSIA as natural wood is exempt from lead testing.  However for other children’s product safety rules, such as small parts the change may be a material change.

The three major categories of material change are;

  • product design, which includes all component parts , their composition, and their interaction and functionality when assembled.  The manufacturer/importer should evaluate the product as received or assembled by the consumer when examining product design
  • manufacturing process, is a change in how the children’s product is made which could affect the finished products ability to comply with the applicable safety rules.  For each change in the manufacturing process, the manufacture/importer should carefully evaluate the product to ensure it still meets all applicable safety rules or if the change results in new rules being applied to it.
  • sourcing of component parts, is a change that results when the replacement of one component part of a product with another component part that could affect compliance.  This includes, but is not limited to, changes in composition, part supplier, or the use of a different component part from the same supplier who provided the initial component part.

For a domestic manufacturer, there would be a special knowledge of its production design, components and, production processes not found with importers of record using foreign manufacturers.  For example, a domestic manufacturer would know whether a new solvent contains any of the prohibited chemicals such as lead and phthalates, or a replacement mold is made from the same specifications as the previously compliant mold.  Such changes would not be examples of “material change” and unless the importer of record has a very close working relationship with the foreign manufacturer, would not know.

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your testing process to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management  testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.

 

 

Production Testing Plans – What you need to know

December 6, 2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 2

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the second part of this article we will look at the requirements for manufacturers/importers under the Production Testing Plan and ISO/IEC 17025:2005(E) part of the rule.

Production Testing Plan

As discussed earlier, after the initial certification of the product by the domestic manufacturer or importer of record the product must undergo periodic testing to show continued compliance with the same safety rules, bans and standards it was originally certified under.  As outlined in Part 1 of this article, one option is to test the product under the Periodic Testing Plan.  Another option, which we will discuss now is called the Production Testing Plan.  A Production Testing Plan would be conducted at the manufacturing site whether it be domestic or foreign and would outline the production management techniques and tests that would be performed to show the continued compliance of the products produced.  A Production Testing Plan may include these following elements;

  • recurring testing at the factory and/or the laboratory
  • the use of process management techniques
    • control charts
    • statistical process control programs
    • failure modes and effects analyses (FMEA)
  • measurement techniques (nondestructive)

Whatever Production Test Plan is designed by the manufacturer it must be effective in showing continued compliance with the safety standards that the product was originally certified under.  Production Test Plans cannot consist solely of mathematical methods but must include some testing.  The CPSC has allowed that testing DOES NOT need to be the same test methods used for certification of the product.  If these test methods are different from the certification testing the manufacturer must document the production testing methods used to show how these methods ensure continuing compliance for safety certification of the product.  For example, if under the original certification a component of the product was tested under the small parts regulation, then the manufacturer may demonstrate continue compliance by measuring how affectivity that component is attached to the product.

A Production Testing Plan must contain the following items;

  • a description of the production testing plan to include;
    • a description of the process management techniques used
    • the tests to be conducted
    • the measurements to be taken
    • the intervals at which the tests or measurements will be made
    • the number of samples tested
    • the basis for determining that the combination of process management techniques and tests continued compliance of the product if the tests used are not the same as the ones used for certification of the product
    • a copy of the production plan at each manufacturers site and a specific plan for each children’s product manufactured there
    • a production testing interval that would ensure that any sample selected for production testing would comply with all applicable children’s product safety rules

 

If the production testing plan fails to provide that “high degree of assurance” of compliance for the products tested, the CPSC may require the manufacturer to show compliance using the Periodic Testing Plan as discussed in Part 1 of this article.

 

An importer can arrange for a foreign manufacturer to develop and conduct a production testing plan for a product.  The same production testing plan from another party may be used by multiple importers as a means of increasing the importers’ maximum periodic testing interval to two years.  The importer, as the product certifier, must use due care to ensure that the implementation of a production testing plan by the manufacturer ensures with a “high degree of assurance” that continuing production complies with the applicable product safety rules.

 

ISO/IEC 17205:2005(E)

A modification of the Production Testing Plan, would require manufacturers to conduct any testing done under the plan using an ISO/IEC 17205:2005(E) laboratory.  These tests which would be done by a CPSC accredited laboratory must be conducted at least every three years.  The manufacturer must ensure that the same test methods used for certification of the product are used to show continued compliance of the applicable children’s product safety rules.  Using the information obtained from this testing, the manufacturer will determine the appropriate testing interval and the number of samples needed for periodic testing to ensure continued compliance.

If this continue testing fails to provide the “high degree of assurance”, the CPSC may require the manufacturer to show compliance using the Periodic Testing Plan.

The advantages of these two test plans would be to extend the length of time between certification testing form annually to every two or three years, depending on the testing plan selected.  If the certifier of the product is an importer of record using a foreign manufacturer, the importer must closely work with the foreign manufacturer to ensure that either testing plan be well documented and shows that continued production of their product complies with all applicable product safety rules.

 

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review or create your Production Testing Plan to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management  testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.

Requirements for Manufacturers/Importers under the Periodic Testing Plan part of the CPSIA section 102 rule. Are YOU Ready?

December 6, 2011 by Bill Jacoby,

CPSIA Testing, Labeling and Certification

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the first part of this article we will look at the requirements for manufacturers/importers under the Periodic Testing Plan part of the rule.

Periodic Testing Plan

Under a Periodic Testing Plan the certifier (domestic manufacturer or importer) would be required to develop a testing plan that would ensure a children’s product manufactured continues “with a high degree of assurance” to meet the safety standards that the product was originally certified under.    The certifier of a children’s product must also determine the frequency of periodic testing (no less than once per year) and the number of samples to be tested.    There are provisions within this rule that would allow the manufacturer to extend the testing frequency to either two (2) years or three (3) years and will be discussed in a later article.

The CPSC has stated in its comments on this rule that it does not want CPSC accredited laboratory’s determining the number of samples that should be submitted for testing.  The CPSC expects the domestic manufacturer/importer to specify to the laboratory the number of samples needed for testing in order to show compliance for the product.  With the wide variety of children’s products, manufacturers, and manufacturing processes that would be subject to this rule, the CPSC felt it would be impractical to give guidance on specific sampling methods that could be applied to all products.  It is therefore important for the domestic manufacturer/importer to use their knowledge of the product and how it is manufactured in order to determine a method for determining the number of samples needed for testing.  Whatever method is chosen it must clearly document that a sufficient number of samples were selected in order to achieve “a high degree of assurance” for compliance.

In general a Periodic Testing Plan must include:

  • the tests to be conducted
  • the intervals at which the tests will be conducted
  • the number of samples to be tested

 

If the Periodic testing plan is conducted by the manufacturer (foreign or domestic), then each manufacturing site must have a periodic testing plan specific to each children’s product manufactured at that site.  If the importers of record are conducting the periodic testing plans then these plans must be retained by the importers of record.

 

The testing interval for a periodic testing plan may vary depending on the specific children’s product rule and the nature of the product but may not exceed one year.  Factors with which a manufacturer/importer may use to determine the testing interval are;

  • Extreme variance in test results (from sample to sample)
  • Results that are close to the allowable regulatory limit
  • Known factors in the manufacturing process that could affect compliance for a rule (example would be a casting die that has a useful wear life and is nearing the end of that wear life)
  • Consumer complaints or warranty claims
  • New or newly sourced component parts that are introduced into the assembly/manufacturing process
  • After the manufacture of a fixed number of products
  • The potential for serious injury or death resulting from a noncompliant product
  • A dramatic increase in the number of products produced annually
  • How often similar children’s products are tested by other manufacturers

The CPSC has also stated that domestic manufacturers/importers my use the testing certification from suppliers of component parts in order to show final product compliance as long as it meets the requirements under 16 CFR 1109 which outlines the conditions for relying on component part testing for certification.

Finally, the domestic manufacturer or importer is responsible for issuing a Children’s Product Certificate for the children’s product they manufacture or import.  For the importer using a foreign manufacturer issuing a Children’s Product Certificate involves one of two choices; one, if the importer has documentation of the manufacturing process (changes in suppliers, changes in component parts, etc.) and the testing data (laboratory report) then it can  issue a Children’s Product Certificate for that product or two if the importer has no knowledge of the manufacturing process then it should treat each shipment as a discrete lot and subject it to certification testing.  At this point the CPSC feels that the importer does not know whether material changes have been made to the product since its last shipment.  In regard to that shipment, the CPSC has put forth that it is not considered continuing production of the product and is therefore not subject to the periodic testing requirements.

 

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review or create your Periodic Testing Plan to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management  testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.

Heads-up – New CPSC On-line Reports Pose New Risks for Manufacturers

Nov 16, 2011

By Lee L. Bishop / Product Safety Letter
On Nov. 8, 2011, The Consumer Product Safety Commission (“CPSC”) formally announced two changes to its on-line reporting tools, changes that had been implemented without fanfare several weeks ago. First, the CPSC has stopped its practice of notifying manufacturers via regular mail of consumer complaints that do not qualify for inclusion in the SaferProducts.gov on-line database. Those complaints will now be accessible to manufacturers (not the public) in a separate tab at the same website housing the searchable database. Second, the CPSC has changed its on-line form used to file initial reports of product defects under Sec. 15(b).

The CPSC press release characterizes these changes as simply a more efficient way to handle consumer complaints, and an “easier” way to report potential product hazards.

No, not really. These two changes present real risks and challenges for manufacturers.

Section 6(c) Information

The first change is not objectionable on its face, but manufacturers must remain vigilant that it is not misused. Some consumer complaints do not qualify for inclusion in the SaferProducts.gov database for a variety of reasons; for example, they may complain of a non-safety problem, or they could not contain the required consumer contact information or verification. These complaints (called “Section 6(c) information”) have been mailed to manufacturers for comment under the process described in 16 C.F.R. Part 1101. They can be obtained by the public only through the Freedom of Information Act.

Now these complaints are on-line, available only to manufacturers as a separate tab on the SaferProducts.gov website. They will no longer be mailed to manufacturers – if you wish to see and comment on these complaints, you must register on SaferProducts.gov. Remember that these Sec. 6(c) complaints are subject to different rules than the new Section 6A complaints. Section 6(c) complaints can only be obtained through a Freedom of Information Act request, and manufacturers can object to their release pursuant to the Part 1101 rules.

Section 15(b) Report Form

For several years the CPSC has encouraged the use of an on-line form to report potential Section 15(b) product hazards. The previous form had open fields for critical information, such as the nature of the defect and how the reporter learned of the potential issue. Since reports are normally filed early in the investigation process, as required by the CPSC’s guidelines, often this information is preliminary, tentative, or simply not available. The form was used to start the process of either conducting a Fast Track recall or developing the facts necessary to support a “preliminary determination” of product hazard by the CPSC staff. The manufacturer would provide more complete information in its Full Report.

The new form is significantly different. It requires that the reporter state a precise date when the issue was discovered – it is not possible to file the report without this critical fact. Given the CPSC’s practice of evaluating every Section 15(b) report for a “late reporting” penalty, and the higher penalty authority provided in the 2008 CPSIA, the date a potential product hazard was discovered has significant legal consequences and should not be volunteered without careful thought and analysis.

The new form also requires that the reporter pick from a “drop-down” menu of “primary” and “secondary” hazards, including “electrocution/electrical shock” or “fire.” Moreover, the report form requires that the reporter pick precise numbers of products involved, their date of production and importation as well as their precise location in the distribution process.

In addition, the new form significantly limits the amount of text available in some of the fields. As a result, it is no longer possible to include the full text of the denial of substantial product hazard as allowed by 16 C.F.R. §1115.12(a).

If manufacturers do not have the information required by the new form, or if they want to formally document the denial of a substantial product hazard (which can be important for a number of reasons) they should consider reporting the old fashioned way – by phone or email containing a letter (in pdf format).

The opinions expressed are those of the author and do not necessarily reflect the views of the firm, or its client. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

Lee L. Bishop is of counsel with Miles & Stockbridge. For 16 years prior to that he was Senior Counsel for Product Safety and Regulatory Compliance for GE consumer products, lighting and electrical industrial equipment. Contact him at (502) 213-0000, lbishop@milesstockbridge.

 


Pointlessly dangerous toys, 2011 edition

TUESDAY, NOVEMBER 22, 2011  Jeff Gelles- Philadelphia Inquirer

Toys made with lead and phthalates continue to pose needless risks to U.S. children, according to the annual “Trouble in Toyland” report from U.S. PIRG.  Its findings are worth keeping in mind this holiday season as you shop or unwrap gifts for your kids  – especially for the babies and toddlers most as risk.

You can find the report here. U.S. PIRG says this year’s key findings include:

Lead Continues to be a Hazard in Toys

Exposure to lead can affect almost every organ and system in the human body, especially the central nervous system. Lead is especially harmful to the brains of young children and has no business in children’s products.

This year our investigators found 2 toys whose lead levels exceeded the current 300ppm standard set by the [Consumer Product Safety Improvement Act] and one additional toy that exceeded its prospective 100ppm standard; we found 4 additional toys that exceeded the American Academy of Pediatrics recommendation that lead levels in toys should not exceed 40ppm.

Phthalates in Toys

Numerous studies have documented the potential negative health effects of exposure to phthalates in the womb or in child development. U.S. EPA studies show the cumulative impact of different phthalates leads to an exponential increase in harms including premature delivery and reproductive defects. The CPSIA permanently banned toys containing three phthalates and set temporary limits on three others, while tests continue. No toy or childcare article can contain more than 1000ppm of each of the six phthalates.

This year, we found two toys that laboratory testing showed to contain 42,000 ppm and 77,000 ppm levels of phthalates. These products exceed limits allowed by the CPSIA by 42 and 77 times, respectively.

Choking Hazards

Choking on small toy parts, on small balls, on marbles and balloons continues to be the major cause of toy-related deaths and injuries. Between 1990 and 2010, over 200 children died from a choking incident.

This year we found several toys that violated CPSC’s small parts for toys standard intended for children less than 3 years old. We also found “near small part” toys that – while not in violation of current regulations – support our call for the small parts test to be made less permissive. Finally, we found toys intended for older children that failed to provide choking hazards warnings required for small parts or small balls.

Noisy Toys

Research has shown a third of Americans with hearing loss can attribute it in part to noise. The third National Health and Nutrition Examination Survey showed one in five U.S. children will have some degree of hearing loss by the time they reach age 12; this may be in part due to many children using toys and other children’s products that emit loud sounds such as music players. The National Institute on Deafness and other Communication Disorders advises that prolonged exposure to noise above 85 decibels will cause gradual hearing loss in any age range.

We found 1 toy on store shelves that exceeded the recommended continuous exposure to 85-decibel limit and 2 close-to-the-ear toys that exceeded the 65 decibel limit when measured with a digital sound level meter.

As often happens, the toys singled out by U.S. PIRG tend to be inexpensive – this year’s top price is $11.99 – and seemingly innocuous.  And it’s true that the annual report draws some criticism as alarmist, perhaps because of its perennial title.

This year is no exception. Even before U.S. PIRG released this year’s report, the Toy Industry Association was ready with a statement warning: “During the holiday season, consumers are frequently targeted by activists who take advantage of the high visibility of toys and the opportunities they offer for media coverage.”

The TIA says:

The reports of such organizations ignore that toys are highly regulated and do not contain hazardous substances to which children may be exposed. They ignore that the U.S. government consistently lists toys among the safest of 15 common consumer product categories in the home. And they ignore that less than half of one percent of the estimated three billion toys sold each year in the United States are recalled.

You can read the rest of TIA’s statement here, and the group’s own safety advice here. The organization is right to recommend that toy risks be understood in their context, but wrong to say flatly that toys “do not contain hazardous substances to which children may be exposed.”

Plainly, sometimes they do – if you have any doubts, look at the Consumer Product Safety Commission’s list of toy recalls, which includes the recall of lead-painted toy cars as recently as Sept. 28.  And take note of the math: Less than half of 1 percent sounds low, but the group could also say “fewer than 30 million toys.” (Actually, I’d be surprised if the number were anywhere near that high.)

More to the point, the relative rarity of problem toys, and their low prices and ordinariness, are sort of the point.

Yes, most toys sold in the United States are safe. But at least a few aren’t, and the results can be tragic.  Do you want someone you love needlessly exposed to choking hazards or to risky substances such as lead, phthalates or cadmium?

As always, “Trouble in Toyland” contains a wealth of information about real risks in the marketplace that are easily overlooked, including toys that violate legal standards or recommendations of authorities such as the American Academy of Pediatrics. The report may reflect the perspective of “activists,” but it’s also a good primer on the underlying policy debates over how to best limit risks imposed on consumers by the occasional manufacturer or importer who violates the rules or pushes the limits.

“Trouble in Toyland” is worth a look. Again, you can find it here.

Read more: http://www.philly.com/philly/blogs/consumer/Risky-toys-2011-edition.html#ixzz1eSqcpMfE

CPSC Safety Rules & January 1, 2012 – What You Need to Know

CPSC Small Business Ombudsman – 11/21/2011

Dear CPSC Small Business Community:

 

As you may know, on January 1, 2012, manufacturers and importers of children’s products will be required—for the first time under federal law—to third party test and certify their children’s products for compliance with the limit on total lead content in children’s products.  Manufacturers and importers will also be required to third party test and certify that toys and certain child care articles are compliant with the federal toy safety standard and the ban on certain phthalates.  We are reaching out, in the spirit of partnership, to provide you with new and updated education and guidance materials (described below) to ease the transition for affected businesses as the stays of enforcement expire for these regulations.  We want to work with you to ensure that you are familiar with these new requirements and to address your concerns.

 

Toy Safety Standard & the Ban on Phthalates

 

Recently, the U.S. Consumer Product Safety Commission (the “Commission”) announced the development of a strategic outreach and education plan to help the business community and other stakeholders learn about the third party testing and certification requirements that will go into effect on January 1, 2012, for children’s toys and toy chests manufactured after December 31, 2011.  For more information on the toy safety standard, please see our website at: www.cpsc.gov/toysafety.  Also, while you are visiting our website, please review our strategic outreach and education plan in the upper right hand corner of the page, and provide us with additional ideas and feedback about our plan.

 

Third party testing and certification requirements will also go into effect for the ban on certain phthalates for children’s toys and certain child care articles manufactured after December 31, 2011.  For more information about the ban on phthalates in toys and certain child care articles, please see our website at: www.cpsc.gov/phthalates.

 

Total Lead Limits in Children’s Products

 

January 1, 2012 also represents the date on which the Commission will begin to enforce the third party testing and certification requirements for the total lead limit of 100 parts per million in accessible parts of children’s products.  Unlike the toy and phthalate requirements, this requirement is for children’s products manufactured after August 14, 2011.   For more information about the total lead limits in children’s products, please see our website at: www.cpsc.gov/lead.

 

Certification and Third Party Testing

 

For all children’s products safety rules, certification and third party testing are generally required.  Certification means that manufacturers and importers of children’s products must issue a written Children’s Product Certificate (CPC) for each product, which identifies the product, the rule or standard with which it must comply, the third party laboratory where it was tested, and other requirements. Certification must be based upon the results of third party testing, which means testing performed by a third party, accredited laboratory that the Commission has accepted to perform the specific tests associated with each children’s product safety rule. For more details about what third party testing and certification means for your business, and for links to our list of accepted laboratories and sample certificates, please see our website at: www.cpsc.gov/3PT and www.cpsc.gov/labsearch.

 

Small Batch Manufacturers

 

In certain situations, qualifying small batch manufacturers may not be required to third party test their children’s products in order to certify compliance with one particular group of children’s product safety rules.  It depends on the children’s product and the materials used to manufacture that children’s product.  Specific information on third party testing requirements for small batch manufacturers is available at www.cpsc.gov/smallbatch.

 

Sign-Up for Updates

 

For future updates on this and other regulatory issues that may affect you, consider signing up for one of our e-mail services.  We have also just created an account on Twitter (@CPSCSmallBiz) and you can choose to follow us on Twitter for regular updates.  The Small Business Ombudsman’s e-mail service sign-up form is at www.cpsc.gov/sbo on the upper right hand side of that Web page.  And, at www.cpsc.gov/lists.html, you will also find a sign-up form for other useful Commission e-mail services of interest.  Of course, if you have additional questions about these requirements, you may always contact me at www.cpsc.gov/sbo by clicking on the  “Contact Form” on the upper right hand side of that Web page for the fastest response.

 

Please do not wait to take the necessary actions to ensure that your products comply and are properly third party tested and certified on January 1, 2012.

 

I hope that we can work together to ensure a robust compliance rate with these new requirements in order to protect consumers better and to ensure that businesses have a level playing field in providing safe and compliant consumer products to the American consumer.

 

Sincerely,

 

 

Neal S. Cohen

Small Business Ombudsman

U.S. Consumer Product Safety Commission

CPSC Launches Online Reporting Tool For Businesses

The SaferProducts.gov Business Portal Changes Are Part of CPSC’s Information Technology Modernization Effort On November 8, 2011, the U. S. Consumer Product Safety Commission (CPSC) announced new features to the SaferProducts.gov Business Portal that it claims will make it easier and more efficient for businesses to work with CPSC. These changes are a key part of the agency’s overall information technology modernization effort.

A new, comprehensive online form allows manufacturers, private labelers and importers to quickly submit required reports of potentially hazardous or defective products to CPSC. The online form makes it easier for businesses to report product hazards and to communicate information on consumer product safety issues with CPSC.

Another improvement expands CPSC’s ability to correspond with all registered businesses on SaferProducts.gov using the Business Portal,instead of postal mail. All registered manufacturers, importers and private labelers identified in incident reports will now receive notices electronically, regardless of whether the report is eligible to be published on SaferProducts.gov. Previously, businesses could only receive SaferProducts-eligible reports electronically. With this release, the structure has been put in place to eventually allow businesses registered in the Business Portal to add brand names for products they sell or have sold. Along with brand names, the time periods during which the company sold each brand also can be identified.

These enhancements to the SaferProducts.gov Business Portal are largely a response to requests and feedback CPSC received from businesses and trade associations.

Have you registered YOUR business on the saferproducts.gov site? 
If you haven't you should do so today!