WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is warning parents and caregivers about the dangers of popular inclined sleep products for infants, citing the findings of a new study. The study is part of a growing body of evidence showing that inclined sleepers with higher angles do not provide a safe sleep environment for infants. Several inclined sleepers have previously been recalled by the CPSC.
The agency continues to emphasize that the best place for a baby to sleep is on a firm, flat surface in a crib, bassinet or play yard. Parents and caregivers should never add blankets, pillows or other items to an infant’s sleeping environment. Babies should always be placed to sleep on their backs.
New Study Confirms: Babies Should Sleep on Firm, Flat Surface
CPSC received reports of 1,108 incidents, including 73 infant deaths, related to infant inclined sleep products that occurred from January 2005 through June 2019. CPSC hired independent expert Erin Mannen, Ph.D., a mechanical engineer specializing in biomechanics at the University of Arkansas for Medical Sciences, to conduct infant testing to evaluate the design of inclined sleep products. Dr. Mannen measured infants’ muscle movements and oxygen saturation while in various products and positions, such as a flat crib, an inclined crib, and several inclined sleep products. Dr. Mannen found that none of the inclined sleep products her team tested is safe for infant sleep. Dr. Mannen’s report was conclusive that products with inclines 10 degrees or less, with flat and rigid surfaces, are likely safe for infant sleep. Dr. Mannen also found that soft and plush-like sleep surfaces pose dangers to infants.
What Should Parents and Caregivers Do Now?
- Stop using infant sleep products with inclined seat backs of more than 10 degrees. Parents and caregivers should not use infant car seats, bouncers, and other infant inclined products for sleep, and should follow manufacturer instructions.
- Follow safe sleep advice. Bare is Best: Do not add blankets, pillows, or other items to the baby’s sleep environment. Back to Sleep: Always place infants to sleep on their backs on a firm, flat surface.
- Check www.cpsc.gov often to see if your nursery products have been recalled, and promptly follow the recall instructions to receive a refund, replacement, or repair. Consumers who register their nursery products with the manufacturer’s registration card (included with nursery items) can be contacted directly by the manufacturer if there is a recall.
The U.S. Consumer Product Safety Commission (CPSC) has launched a new CPSC Recall App to make recall information currently on their website more accessible to consumers on their mobile devices.
Since 2012, the Consumer Product Safety Commission (CPSC) has required companies that have entered into settlement agreements for failure to report under Section 15 of the Consumer Product Safety Act (CPSA) to develop internal compliance programs. Through these settlement agreements, it is obvious that the CPSC considers the implementation and maintenance of a compliance program to be the cornerstone of how a company ensures compliance with product safety rules and regulations enforced by the CPSC.
The difficulty is not in the development and implementation of an effective Product Safety Compliance Program, but in developing a mechanism to review, evaluate and update the compliance program.
So how do you know if your program is up-to-date and if you are using the best process and technology available today? In the early days of CPSIA, many companies built internal systems and controls to track testing and to generate certificates. Many of these systems are 4-6 years old now and were not built to send paperless certificates, as put forth in the rule on “Certificates of Compliance”, 16 CFR Part 1110 (the 1110 rule). At many companies, a review of their compliance program has not been done since 2013 when the CFR 1107 rules when into effect. Failure to regularly review and update all relevant information, which might impact the compliance of your childrens’ product, negates the effectiveness of a Consumer Product Safety Compliance Program.
Perform an Audit
To begin the review of your current product safety program, an audit must be conducted to assess your product safety readiness, including your current systems, operations and technology platforms. During the review, charting the incoming data to technology, processes and the people involved, should be conducted. Knowing where all of the compliance related data for the company is stored, and how it can be accessed, is important when information is needed quickly. In the event of an incident, the decision to report under Section 15(b) to the CPSC needs to be made quickly, so knowing where to find your data is essential.
Map Your Incoming Data to People, Process and Tools
The next step is to chart your processes so that incoming product data will be available to effectively support your Product Safety Compliance Program. This data should be collected from the design stage through final product delivery to consumers. Is there a proactive approach to compliance so that you can quickly react to incidents reported by consumers who are using your products, once you are made aware of them? You may have data residing on in-house developed systems, 3rd party applications, vendor sites or web applications like Dropbox or SharePoint. Your goal should be to maintain and enforce a system of internal controls and procedures to ensure that your company can promptly, completely, and accurately report the required product information to the CPSC if necessary.
Sources to Discover Safety Related Incidents
There are many sources to discover safety related incidents. Do you have process and technology tools in place to capture these? How are these issues escalated and what platforms do you use to review, research and document issues brought to your attention? Many companies today use online help desk platforms to log customer service inquiries and most of the top programs today have an API connection so that you can bring in items from Facebook and Twitter. Application program interface (API) is a set of routines, protocols, and tools for building software applications. An API specifies how software components should interact and APIs are used when programming graphical user interface (GUI) components. So when looking for new technology platforms, look for ones that have the ability to use an API to connect to other applications or to bring or send data to your systems or compliance program.
Your internal company communications policy should be set up to enable management to quickly be informed of any safety related incidents or quality issues.This policy should start with the appointment of a company compliance manager and notification/training to your staff on your escalation policy. Do you have your systems set up to capture safety related incidents and route them to the compliance manager/director? A lot of programs today utilize a smart rules feature so you can escalate a category type such as safety and quality so that these items can be routed directly to your compliance manager the minute they are created. It is important to note that with or without a technology solution, you must train your customer service staff to recognize safety related issues and direct them on proper incident handling protocols and company polices so they are prepared to escalate to management when discovered.
Identify Your Training Platform
During the review of your compliance program you should identify and document the communication platform that you will use to train your staff, contractors, stakeholders and board members on your company’s compliance policies. Will it be all-hands meetings, video conferencing or 3rd party apps, and how will you capture proof of attendance? You should embed this training for new hires if they work in an area related to purchasing, testing or customer service, and a confidential reporting process should be part of this training so you foster a proactive approach to safety.
Many companies which have been in business for some time find that their data is spread out over legacy systems, shared drives, company servers or staff computers. In your audit you should identify where all of this data is stored and how it is backed up. Cloud based applications and storage solutions are much more cost effective today and offer increased security over dedicated IP-based servers. You should have a data migration plan for migrating or storing data when systems are upgraded and know where to find archived data. If you have an IT department, make sure your document retention policy is inline with CPSC requirements, which is 5 years, and integrate your company email retention policy with your compliance program. Educate your employees on proper storage of files and documents.
Think outside the box
When developing your compliance program there is no one-size-fits-all approach. After completing an audit of your current program you can then identify possible technology solutions to adopt or to fill the gaps in your current systems. Keep in mind that your compliance program should encompass your company’s product testing and certification program so that compliance with all applicable federal and state children’s product safety rules and regulations is ensured. The days of using Excel spreadsheets solely for the documentation and implementation of your compliance program are quickly ending, but there are many great solutions available out there today, you just need to find the one that best works for you.
For more information on a conducting compliance program audit or help with creating your CPSC Compliance program please contact us by visiting the Jacoby Solutions website.
If you are a registered small batch manufacturer with the U.S. Consumer Product Safety Commission (CPSC) for calendar year 2015 and you wish to continue in this status, you must register again for calendar year 2016. Registration must be submitted annually.
If you have not previously registered your small business with CPSC, but now wish to do so, please follow the instructions below but note that you will first have to create a user ID and password before you will be able to follow all of the steps below.
Registration is now open for calendar year 2016.
If you wish to register as a small batch manufacturer for calendar year 2016, your registration must be based upon the total number of the same product units sold (7,500 units) and the total gross revenues ($1,086,627 or less) from the sales of all consumer products in the previous calendar year – January 1, 2015 through December 31, 2015. If you meet those two requirements (the total gross revenues figure has been updated for inflation this year), you may now register for calendar year 2016 by logging into your user account in the Business Portal at: www.SaferProducts.gov.
Step 1: Login: When you log in to your account at: www.SaferProducts.gov and you click the “Small Batch Manufacturer” tab with your cursor, you will be asked to attest that your company satisfies the criteria you first used to register; the criteria are nearly the same as last year and only the gross total revenue figure has been updated to account for inflation.
If you do not see the “Small Batch Manufacturer” tab on your screen when you login, you may be using the wrong email login. Remember that you may have used multiple emails when you created your account. You should use the Business Account User ID login, which is often a general address, such as firstname.lastname@example.org, and not your personal or other email address, such as email@example.com. If you login correctly, you will be able to see all the tabs, including ‘Small Batch Manufacturer.’ If you need further assistance logging in, contact Clearinghouse@cpsc.gov.
Step 2: Registration: Once you are certain that you can attest to the truth and accuracy of the statements for your sales and your revenues in calendar year 2016, you may check the boxes and submit your registration. Within the next day or so, you will receive a confirmation e-mail message with your new, unique Small Batch Manufacturer Registration Number for 2016. *Please save that e-mail message for your reference.*
Please note that when you log in to your account after your registration for calendar year 2016 is accepted, your Business Portal account will display your unique Small Batch Manufacturer Registration Number for both calendar year 2015 and calendar year 2016. Please use the appropriate number (from 2015 or 2016, based on the date of your product’s manufacture or final assembly) in drafting your Children’s Product Certificate.
Total Gross Revenues: Note that the total gross revenues for your company from the prior calendar year (e.g., calendar year 2015 sales to qualify for calendar year 2016) from the sale of all consumer products must be $1,086,627 or less.
(If your company’s revenues are currently $900,000 or more, we recommend that you defer registering with the CPSC until the final 2015 figures are released – the figure above will not be finalized until early 2016. The size of the final inflation adjustment is still unknown. If you register before the release and your revenues exceed the maximum allowed amount as adjusted in 2015, you must notify the CPSC to cancel your registration.)
Registration is ongoing, and you may register at any time during the next calendar year – through December 2016.
Assistance: If you have any questions or require assistance with the registration process, please e-mail: firstname.lastname@example.org.
If you have any questions about how registration as a small batch manufacturer with the CPSC affects your obligations to test and certify your products as compliant with applicable consumer product safety rules or compliance with other CPSC rules, regulations, standards, or bans, please review the program information at: www.cpsc.gov/smallbatch. If you need further assistance, please e-mail Neal Cohen at: email@example.com.
Two California toy importers have agreed to use Independent Product Safety Coordinators to create compliance programs to settle allegations of violating CPSC requirements, the Justice Department noted in a October 6 press release. They are decreed from selling and importing toys or other children’s products until these programs have been set up.
The companies are Unik Toyz Trading and Brightstar Group, both of Los Angeles. The complaints and settlements also name company officers: Julie Tran and Kiet Tran (Unik) and Sherry Chen (Brightstar)
Both decrees mandate the creation of compliance programs requiring the following:
- Use of Independent “Product Safety Coordinators” (no financial or personal ties) who would help set up a comprehensive product safety compliance program and audit products to determine which require testing and certification to CPSC rule.
- Engage an CPSC accredited third party lab for product testing
- Periodic product testing plan according to 16 CFR 1107.
- Conformity certificates retained and available to provide at CPSC’s request. The companies must have processes to verify that all underlying requirements are satisfied.
- Warning labels on all products requiring them.
- Tracking labels on all products that require them.
- Correction procedures to fix problems, conduct recalls, and respond to CPSC letters of advice.
- Incident reporting procedures to investigate incident reports, meet CPSC reporting requirements, and correct “systemic issues” found by the investigations.
Under both decrees, the companies must certify to the Compliance Office that they have met all provisions, accept CPSC facility inspections to ensure such compliance, and submit to at least two years of CPSC monitoring.
The CPSC sent 21 letters of advice to Unik from November 2011 to January 2015. The allegations involved lead content, phthalates, small parts, accessible batteries, art material labeling, third-party certification, and tracking labels
The Brightstar allegations involved lead content, warning labels on marbles, strollers’ folding mechanisms, third-party certification, and tracking labels. The CPSC sent nine letters of advice to Brightstar from September 2013 to April 2015.
Over the last several years, the creation of a compliance program has become a mandatory element of every settlement with the CPSC.
The CPSC expects companies to have a robust compliance plan in place. Do you have all of the required elements in place? Let Jacoby Solutions be your Independent Product Safety Coordinator and call us to schedule a CORE audit to see how your People, Process and Technology stack up..
The International Consumer Product Health & Safety Organization (ICPHSO) announced that Marc Schoem, currently with the US Consumer Product Safety Commission (CPSC), will be taking the reins as Executive Director of ICPHSO on October 15, 2015. The position has been unfilled since the founding Executive Director Ross Koeser retired in February of this year. Schoem will retire from CPSC in early October.
Founded in 1993, ICPHSO (pronounced IC – FAH – SO) is the only organization which attracts a global membership of consumer product health and safety professionals, all of whom come together to exchange ideas, share information, and address health and safety concerns affecting all consumers. ICPHSO members represent U.S. and global government agencies, manufacturers, importers, retailers, trade associations, certification/testing laboratories, law firms, academia, standards development organizations, media, and consumer advocacy groups.
Al Kaufman, current ICPHSO president, stated, “I know I speak for the entire ICPHSO board of directors when I say that we are very excited to have Marc on board. Having someone of Marc’s caliber, with the vast experience he brings to this role, serving as Executive Director will enable ICPHSO to grow and prosper, furthering our mission of providing a neutral forum where product safety practitioners from many organizations can come together to advance the art and science of protecting consumers.”
Schoem brings 40+ years of experience at CPSC to IPCHSO, working directly with many of the members and stakeholders in the product safety arena. His current position is Deputy Director, Office of Compliance and Field Operations, U.S. Consumer Product Safety Commission. Since joining the Commission in 1974, Mr. Schoem has served in a number of positions in its Bureau of Information and Education, Office of Education, Global Outreach and Small Business Ombudsman and the Office of Compliance and Field Operations.
“I am looking forward to this unique opportunity to lead ICPHSO,” stated Schoem. “ICPHSO is an organization that exists to bring together consumers, members of industry, global government regulators and other key players in the consumer product safety field to discuss and exchange ideas to improve consumer product safety throughout the world. This is a natural extension of the role I have played at CPSC for the last 40 years. My hope is to build ICPHSO into an even stronger and more vibrant organization that can help stakeholders address emerging safety issues and further the dialogue between all parties involved with consumer product safety in a non-partisan and inclusive approach.”
Schoem will make his first appearance as executive director of ICPHSO at the organization’s International Symposium in Billund, Denmark on October 20-21, 2015.