Demonstrating what the CPSC calls “due care” with regard to the periodic testing rule

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As an importer who relies on my overseas manufacturer to test the product before shipping to the US, how would I demonstrate what the CPSC calls “due care” with regard to the periodic testing rule?

 

There are several approaches that may serve as evidence of due care by an importer to ensure that a foreign manufacturer who has provided a testing certification for product, conducts periodic testing as specified in the final rule.

First, the requirement should be specified in the importer’s purchase order to the foreign manufacturer, clearly communicating the requirement to conduct the required periodic testing and requiring submission of the foreign manufacturer’s periodic testing plan, production testing plan, or the results of continued testing using an ISO/IEC 17025:2005 -accredited lab.

Second, an importer may need to conduct occasional site visits to his supplier’s manufacturing facility to examine evidence that the required periodic testing has been properly performed.  Simply reviewing the foreign manufacturer’s periodic testing plan or production testing plan may not satisfy the requirement, without further evidence that the plans were actually implemented.  (Think Audit of Factories)

Third, an importer may need to verify the authenticity of the supplier’s test reports by contacting the testing laboratory for verification of the testing or have the test report reviewed by another party.

Fourth, an importer may also wish to occasionally submit samples from products received from the supplier for testing, to compare the test results to those conducted by the foreign manufacturer

 

For more information regarding your companies compliance with CPSIA, contact Jacoby Solutions today.  We can help!

What is the purpose of periodic testing? (Based on 16 CFR Part 1107)

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The purpose of periodic testing is to ensure the compliance of continued production of a children’s product to all the product safety rules it was first certified for.  The CPSC defines periodic testing in their FAQ as, “The general principle set forth in the regulation is that you, as the manufacturer, must have a periodic testing plan and conduct periodic testing (using a CPSC-accepted laboratory) at least once per year.”

Previously tested children’s products or component parts of children’s products do not require periodic testing.  If the children’s product or component part of a children’s product was sampled and tested for certification purposes, those test reports remain valid for the remainder of that particular lot or batch of the children’s product or component part of the children’s product.

Continued production or importation of the same children’s product or component part of a children’s product (assuming no material changes that would require re-certification) are subject to the periodic testing requirement.

If a manufacturer/importer of record conducted certification testing on each new lot or batch of a children’s product or component part of a children’s product, that testing would constitute recertification of the finished product or component part and therefore periodic testing requirements would not apply.

Based on the final rule of 16 CFR Part 1107, continuing production of a children’s product or component part of a children’s product would have to select either a representative sample or random sample technique(s) for periodic testing purposes.

Conducting Undue Influence Training

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Can I use a software program or website to conduct the training needed to satisfy the “undue influence” requirement within the Testing and Labeling Pertaining to Product Certification rule or does it have to be in person?

Manufacturers are required under 16 CFR § 1107.24(b)(1) to make sure “that every appropriate staff member receive training on avoiding undue influence and sign a statement attesting to participation in such testing.”  The CPSC has stated that a digital signature or other electronic attestation (such as a check box) that an employee took the training included as part of software or online training would meet the requirement to “sign a statement attesting.”

Need help with Undue Influence training. please contact us today as Jacoby Solutions can help you meet this requirement!

16CFR Part 1107 will be in effect soon

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Here is the essence of what the final rule (16 CFR Part 1107, Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for Periodic Testing of Children’s Products) says.

In order to ensure continued compliance of children’s products produced, the Commission has taken the approach of requiring the manufacturer/importer of record to have knowledge of how tested product samples are similar to untested product samples.

The manufacturer/importer of record can demonstrate this knowledge by; results from prior testing (product has been tested several times with no issues of non-compliance), detailed knowledge of the product itself (in design and material sourcing), the production processes used in the manufacture of the product, the quality control processes used in the production of the product and the production testing plan for the product (testing done at the manufacture site to ensure continued compliance of the product).

So long as the manufacturer/importer of record has a rational basis for demonstrating the similarity of the untested product samples to the tested product samples and documents this rational, then the manufacturer/importer of record is said to have met the requirements in the final rule.

Numerous times the Commission has stated that manufacturers/importers of record are required to know about their products and the manufacturing processes used and implement a testing program accordingly which includes the ability to provide a basis for inferring the compliance of the tested product samples to the untested product samples.  Without this basis the testing done by the manufacturers/importers of record on their products would serve no purpose other than to demonstrate the compliance of the tested product samples and not the entire population of product samples.

Manufacturers/importers of record can use “process” to show that the product samples selected for testing are like the untested product samples.  For example, a process that manages the lots or batches of raw materials used in the manufacture of children’s products (like surface coatings or resins) can be used as a basis to demonstrate the homogeneity of the population of products with regard to chemical testing for lead and phthalates.

Another example would be a process that creates uniformly spaced holes in the crib rails for the uniformly constructed crib slats which can be used as a basis to demonstrate the homogeneity of the population of products with regard to the component spacing test of ASTM f1169-10.

Without this documented basis, mere testing alone is not sufficient to infer compliance of the untested product samples and as such would not meet the minimum due care requirements of 16 CFR Part 1107.

 

Standing Guard for Consumers: CPSC & CBP Working at U.S. Ports to Protect Families This Holiday Toy Shopping Season

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CPSC Media Contact: (301) 504-7908

NEWS from CPSC

U.S. Consumer Product Safety Commission

Standing Guard for Consumers: CPSC & CBP Working at U.S. Ports to Protect Families This Holiday Toy Shopping Season

PORT ELIZABETH, N.J. – Today, U.S. Consumer Product Safety Commission (CPSC) Chairman Inez Tenenbaum and U.S. Customs and Border Protection (CBP) Deputy Commissioner David Aguilar announced at Port Elizabeth, N.J. that more than 2 million units of dangerous or violative toys and children’s products were seized in 2012 and were prevented from reaching the hands of children. CPSC investigators and CBP inspectors are working arm-in-arm at ports across the United States to keep families safe during this holiday toy shopping season.

Over the past four years, CPSC and CBP have stopped more than 8.5 million units of about 2,400 different toys and children’s products due to safety hazards or the failure to meet federal safety standards. By seizing dangerous toys and children’s products at the ports, those products remain off store shelves and out of consumer’s homes.

Chairman Tenenbaum and Commissioner Aguilar urged parents to remain vigilant when making toy purchases and always keep safety at the top of their toy shopping list.

“Proactive port surveillance, strong toy standards, and educational efforts create a safer holiday toy shopping experience for consumers by keeping dangerous products off store shelves,” said Chairman Tenenbaum. “Ultimately our goal is to protect our most vulnerable population – kids – and keep them safe this holiday season.”

“Together with CPSC, we have intercepted record amounts of unsafe products,” said Deputy Commissioner Aguilar. “We are here to raise consumers’ awareness about the very real danger of unsafe products and urge consumers to be vigilant when buying toys and children’s products this holiday season.”

In fiscal year 2012, CPSC recalled 38 toys, three of which involved a lead violation. Toy recalls continued to decline since 2008. There were 172 recalls in fiscal year 2008, 50 recalls in fiscal year 2009, 46 toy recalls in fiscal year 2010, and 34 recalls in 2011. Most toy recalls in 2012 were due to small parts, choking hazards or sharp points.

Toy-related death reports to CPSC involving children younger than 15-years-old decreased to 13 in 2011 from 19 fatalities in 2010 and 17 reported in 2009. The majority of these toy-related fatalities were attributed to asphyxiation, choking or drowning. These included children choking on balloons, drowning after trying to retrieve a toy from a swimming pool, or being found with tricycles in swimming pools.

A new report (PDF) released by CPSC today estimated 193,200 toy-related, emergency department-treated injuries to children younger than 15 years of age occurred in 2011. Many of the incidents were associated with, but not necessarily caused by, a toy. For children younger than 15-years-old, non-motorized scooters continued to be the category of toys associated with the most injuries. Frequently, these injuries involved lacerations, contusions, and abrasions to the child’s face and head.

Here are some safety tips that consumers should keep in mind this holiday season:

  • Balloons – Children can choke or suffocate on deflated or broken balloons. Keep deflated balloons away from children younger than 8-years-old. Discard broken balloons immediately.
  • Small balls and other toys with small parts – For children younger than age 3, avoid toys with small parts, which can cause choking.
  • Scooters and other riding toys – Riding toys, skateboards, and in-line skates go fast, and falls could be deadly. Helmets and safety gear should be worn properly at all times, and they should be sized to fit.
  • Magnets – High powered magnet sets are dangerous and should be kept away from children under 14. Building & play sets with small magnets should also be kept away from small children.

 

Once gifts are open:

  • Immediately discard plastic wrapping or other toy packaging before they become dangerous play things.
  • Keep toys appropriate for older children away from younger siblings.
  • Battery charging should be supervised by adults. Chargers and adapters can pose thermal burn hazards to young children. Pay attention to instructions and warnings on battery chargers. Some chargers lack any mechanism to prevent overcharging.

 

Along with educating the public, CPSC is committed to working with foreign and domestic toy manufacturers, importers and retailers to help them understand and comply with U.S. toy requirements.

In addition this year, CPSC joined international safety agencies in Canada and Mexico to promote toy safety education and awareness. CPSC along with Health Canada and Mexico’s Procuraduria Federal del Consumidor (PROFECO) have released toy safety tips for choosing, purchasing and supervising the use of children’s toys. This cooperative effort with CPSC’s North American partners helps to ensure a safer marketplace.

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The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of consumer products under the agency’s jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $900 billion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. CPSC’s work to ensure the safety of consumer products – such as toys, cribs, power tools, cigarette lighters and household chemicals – contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 30 years.

To report a dangerous product or a product-related injury, go online to: SaferProducts.gov, call CPSC’s Hotline at (800) 638-2772 or teletypewriter at (301) 595-7054 for the hearing and speech impaired. Consumers can obtain this news release and product safety information at www.cpsc.gov. To join a free e-mail subscription list, please go towww.cpsc.gov/cpsclist.aspx.

Voices from Outside the Echo Chamber

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  Voices from Outside the Echo Chamber

by Nancy Nord

A regulator’s job description should include a requirement to get out of Washington echo chamber, from time to time, to visit and talk with folks who have to live with our mandates. That is one of the best ways we have to gauge if regulations make sense out in the real world and if there are any issues surfacing as companies work to comply with the law. Last week I was on the road, having just those kinds of conversations.

 

The ABC Kids Expo was a wonderful opportunity to talk one-on-one with smaller companies who make a wide variety of infant and children’s furniture and other products. Without exception, these companies expressed a strong commitment to safety. This makes sense because many of the companies represented were started by entrepreneurial parents who saw either a need going unmet or a way to improve a product. While these companies were very pleased and eager to get whatever information we can offer on how to comply with our rules, I also heard concerns about both the process of writing the rules and the substance of the rules themselves. For example, the agency, working with the voluntary standards bodies, has been issuing the Congressionally-directed durable infant and toddler products regulations at a rapid pace.  Yet there is growing concern, which I heard expressed again last week, that this is resulting in a process that is less rigorous, at times more arbitrary and more error-prone than it used to be. Certainly, this is something that warrants greater attention at the CPSC.

 

I also spent time at the Specialty Graphic Imaging Association Expo, talking with the association’s Board of Directors, conducting a safety seminar and walking the show floor talking with individual members of this very complex and dynamic industry. Here are some of the key points I took home:

  • Overall, component testing is not working as the cost saver we hoped for this industry;
  • CPSIA-required testing is posing challenges in terms of expense and frustration as companies test for substances that are not present but do not fit into the exemptions; and
  • Testing variability among labs, in particular with respect to phthalates testing, is adding time and expense to the process, and is consuming resources in an unproductive manner.

While there are some very large players, the bulk of the industry is made up of small, domestic companies. Because of the nature of the business, the small batch testing exemption does not apply. One small business owner, with fewer than 10 employees, told me of needing to add an employee to do nothing but administer and document his testing and regulatory compliance program. Another told me that since children’s garments were not a major part of his business, he has decided just to get out of that aspect of the business altogether rather than have to hassle with all the rules.

 

I am concerned when I hear reports like that. Congress directed us to look at ways to cut costs. I suspect that, if and when we get serious with a commitment to action, taking that directive seriously, rather than just playing charades with that directive, we will find that there is ample opportunity to provide some real relief. In the meantime, with no boost to safety, the clock is ticking on the existence of numerous U.S. based low-volume businesses and their employees’ livelihoods.

CSPC Draft Staff Briefing Outlines 11 Ideas to Reduce Testing Costs

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The CPSC has released a Staff Briefing that will be discussed and voted on by the Commission on October 3, 2012 that outlines 11 areas the will help reduce the cost of testing and compliance for children’s product manufacturers and importers of record.  The aim at finding burden reducers during fiscal 2013, which begins October 1 and are;

  • Education of companies on testing rules
  • Expand the determination of what should be tested by;
    • Creating a list of tests in international standards that companies could use to show conformity with corresponding CPSC product safety rules
    • Using the same process used now to determine if certain materials need not be tested for lead to be applied to the eight heavy metals now tested for under ASTM F963
    • Expand the current list of materials exempt from testing for phthalates
    • Allow Fourier transform infrared spectroscopy (FTIR) to show phthalate compliance
    • Allow for production volume exemption (under 10,000 units produced) for periodic testing which would require testing compliance every 3 years instead of very year
    • Expand the bodies responsible for accrediting third-party laboratories beyond ILAC-MRA signatories to increase number of testing labs
    • Allow “de minimis” testing exemptions for lead in paint and phthalates
    • Increasing the materials exempt from lead determination to include those deemed safe for addition to food by the FDA
    • Allow companies that do short production runs and recertify their product with each run, not have to create a periodic testing plan for doing so
    • Create classes of products that are deemed “low risk” of noncompliance and allow companies that produce those products to expand the intervals of compliance testing.
    • Reducing administrative costs of compliance through information technology
    • Seek authority from Congress to certify certain manufacturing processes as satisfying testing requirements due to ongoing reassessments involved.

 

The full staff briefing (all 117 pages) can be found here

 

http://www.cpsc.gov/library/foia/foia12/brief/reduce3pt.pdf

Consumer Product Safety Improvement Act celebrates 4th anniversary

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Aug 14, 2012 2:30 PM

Today is the anniversary of the national consumer product safety law that changed safety standards in the U.S. after an outbreak of recalls, injuries, and deaths linked to dangerous children’s products in 2007 and 2008. Under the law, which was supported by Consumer Reports, toys must be tested for safety before they’re sold.

The product safety law, CPSIA, greatly reduced the lead levels found in children’s products, as well as set tougher safety standards for cribs. The law also created the nation’s first online database, SaferProducts.gov, where consumers can file safety complaints about products.

“The database is a tremendous resource for consumers,” said Ellen Bloom, director of federal policy for Consumers Union, the advocacy arm of Consumer Reports. “You can search for safety reports about the products you buy, and if you wind up with an unsafe product, the database is there for you to report the problem.”

Whistleblower Protection and CPSIA

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Whistlebower Protection under the Consumer Product Safety Improvement Act (CPSIA)

Under the CPSIA, 15 U.S.C. §2087, whistleblower protection is offered for employees who are discharged or discriminated against by manufacturers, private labelers, distributors, and/or retailers, because they gave or are giving information to the employer, Federal Government, or attorney general regarding violations of any provision of this Act.

The CPSIA holds that it is unlawful for any person to manufacture for sale, offer for sale, distribute for sale any consumer product not in conformity with an applicable consumer product safety standard as outlined under this statute, or which has been declared as a banned hazardous product.  Any person who believes that he or she was discharged or otherwise discriminated against in violation of this section may file a claim within 180 days after the date on which the violation occurs with any Occupational Safety & Health Administration (OSHA) office.

If the Secretary of Labor finds that the employer committed a violation of this statute, the Secretary shall order the employer to: take affirmative action to abate the violation, reinstate the complainant to his or her former position together with compensation (including back pay) and restore the terms, conditions, and privileges associated with his or her employment, and to provide compensatory damages.

If you are a manufacturer or distributor, you can minimize your risk by having a process in place for employees to report incidents or concerns without penalty.

1.     Find this out

  • Do you believe that your company really wants to find out about problems with your products or potential safety issues related to their use?
  • Would you feel comfortable raising serious concerns to your manager or others in the company believing that they would welcome your concerns and then be committed to investigating and resolving them

Until you find out that most individuals answer this positively , your company has an important gap in  its compliance program and won’ be maximizing its ability to prevent, detect and correct problems no matter how many hotlines, training sessions, policies and directives it implements. Getting positive, enduring responses to these questions is a matter of leadership, company culture, and daily behavior.

2.     The goal is cultural, not administrative

The key focus should be on instituting a culture of compliance in your company. Processes and other administrative measures may help this develop but alone are not insufficient. Overall, the key is to have leaders demonstrate their commitment, individuals learn specific behaviors that help them find out about problems and for companies to establish their long term credibility by acting effectively when issues are brought to their attention.


The information provided above is relevant if you have a company with fifty employees or a company of three. If you are a small company and each employee wears several operational hats, it may not be practical to formally institute a compliance plan right away but it is important to outline policy, procedures and escalation process so that everyone knows who is responsible for what when issues arise. Having a playbook to follow will make it easier as you grow and as more people are added, things will become easier to manage.  Brand protection is paramount to your company’s success and if you want to grow into a big company, it is best to start while you are small to keep compliance an integral part of your everyday business activities.

For help with your companies compliance plan, please contact Jacoby Solutions as we can help you put a plan in place so you never need have to worry about whistleblowers.

Newest version of the CPSC’s toy safety standard, ASTM F963-11,in effect June 12, 2012

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Children’s toys manufactured or imported after June 12, 2012, must comply with all mandatory sections of the recently revised ASTM F963-11. Manufacturers and importers should continue using a CPSC-accepted third party laboratory for the sections of ASTM F963-08 that did not change in ASTM F963-11.

However, for new or revised sections of ASTM F963-11 that are not “functionally equivalent” to the -08, version, manufacturers and importers are not yet required to use a CPSC-accepted third party testing laboratory until the Commission approves a revised Notice of Requirements. As of May 1, 2012, that proposed Notice of Requirements (pdf) is pending, but not yet approved as a final rule, by the Commission.

In the event that a manufacturer or importer wishes to have its products tested now – in the hope that testing to the -11 version eventually will be accepted by the CPSC – that manufacturer or importer should check with its current CPSC-accepted laboratory to see if they will be applying to the CPSC for acceptance of the -11 version. If so, and if the lab satisfies other conditions spelled out in the draft document , then the Commission likely will accept that testing upon its approval of the new Notice of Requirements. (This is not a guarantee of the Commission’s action, but the Commission traditionally has permitted acceptance of such testing, provided that all the other conditions are satisfied.)

The additional requirements in the draft document (pdf) are as follows:

  • The test results show compliance with the nonequivalent section(s) of ASTM F 963-11.
  • The children’s product was tested on or after February 22, 2012, and before the effective date of 16 CFR part 1112.
  • The third party conformity assessment body’s accreditation remains in effect through the effective date of 16 CFR part 1112.
  • The third party conformity assessment body’s application for acceptance of its accreditation is accepted by the CPSC on or after May 24, 2012 and before the effective date for 16 CFR part 1112.
  • The children’s product was tested by a third party conformity assessment body accredited to ISO/IEC 17025:2005 by a signatory to the ILAC-MRA at the time of the test. The scope of the third party conformity assessment body accreditation must include the tests contained in the applicable nonequivalent sections of ASTM F 963-11.
    • For firewalled third party conformity assessment bodies, the firewalled third party conformity assessment body must be one that the Commission, by order, has accredited, on or before the time that the children’s product was tested, even if the order did not include the nonequivalent tests contained in ASTM F 963-11.
    • For governmental third party conformity assessment bodies, the governmental third party conformity assessment body must be one whose accreditation was accepted by the Commission, even if the scope of accreditation did not include the tests for the nonequivalent tests contained in ASTM F 963-11.