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!

JUVENILE & TOY MANUFACTURERS AND DISTRIBUTORS TURN TO JACOBY SOLUTIONS TO ENSURE CPSIA / CCPSA COMPLIANCE

                                                                                                                                                                                                                     FOR IMMEDIATE RELEASE                 Contact:  Bill Jacoby,   info@jacobysolutions.com

JUVENILE & TOY MANUFACTURERS AND DISTRIBUTORS TURN TO JACOBY SOLUTIONS TO ENSURE CPSIA / CCPSA COMPLIANCE

Proprietary CORE Audit™ Evaluates Operational Readiness and Uncovers Compliance Issues

Wilmington, DE (November 15, 2011) – H.R.2715 Bill of the Consumer Products Safety Improvement Act (CPSIA) becomes Federal Law on January 1 with promises of strict enforcement by CPSC Commissioner Nancy Nord.  With manufacturers at risk of facing fines of $100,000 per violation, companies are faced with the challenge of navigating and understanding the evolving regulations to ensure readiness.  Fulfilling a much needed resource, manufacturing industry veteran Bill Jacoby offers his 10 plus years of experience and knowledge in operations and compliance to help companies by auditing their operations and manufacturing processes and offering solutions for areas that need to be addressed.

“We’ve developed a process intent on preventing expensive mistakes,” said Bill Jacoby, president and founder of Jacoby Solutions.  “The process identifies any weaknesses and gives the company the ability to troubleshoot and create solutions that ensure full CPSIA / CCPSA compliance.”

Jacoby developed the CORE Audit (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness.  The audit covers sixteen operational areas including Quality Control, Labeling and Tracking, Issue Escalation, Documentation & Record Keeping, and Incident Reporting as well as CCPSA readiness reporting areas that they are compliant and revealing areas that need immediate attention.

“What many companies don’t realize is that compliance does not stop at testing,” said Jacoby.  “And unfortunately, many businesses do not have the resources in house to decipher the changing law as it relates to their daily business operations.”

To fulfill this need, Jacoby Solutions serves as an affordable resource and consultant to small and medium companies in the juvenile, toy and craft and hobby manufacturers producing products domestically or abroad.  Services will be extended to other consumer product categories in Q1, 2012.

About Jacoby Solutions: Business Transformation With An Eye On Compliance™

Jacoby Solutions is a product-centric consulting practice specializing in “ CPSIA operational readiness,” ongoing CPSIA and CCPSA compliance and operational efficiencies via improved process and systems.  A one-stop shop for manufacturing and distribution companies in need of a partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time and resources by helping them become operationally sound in all areas from manufacturing and distribution to supply chain management and customer service.  Founder and principal, Bill Jacoby has held executive management positions in business operations since 1987 with large corporate and small businesses alike including the last seven years in the juvenile products category.  For more information, go to www.jacobysolutions or email info@jacobysolutions.com.