What You Need to Know About Product Safety Regulations
If you have begun developing your invention and have been confused about how to ensure that you are complying with requirements, don't despair- you are not alone. The last few months, many inventors have asked about safety regulations and testing requirements with a commitment to produce safe and useful products. However, the process for identifying the right steps to take to ensure compliance with requirements is less than obvious for new inventions. The information here is an attempt at clarifying the process. It is by no means intended to, nor does it purport to, provide all the answers. It is the responsibility of each product developer and company to research and determine the level of compliance necessary for each product. We accept no legal responsibility for omissions or errors in this guidance.
*Warning: only a true inventor will be excited to find the following information.*
The Market Environment
The environment for companies who launch new products, particularly those designed for children, is confusing. Certain items such as pacifiers, electric heaters, and cribs have specific ASTM standards to which one can design to and test for compliance. However, clear direction is elusive at best and to a large degree, non-existent for other areas; particularly where there is no prior existence of a product or category. Inventor/manufacturers are left to their own efforts at making common sense decisions on both design and testing. The "system" for overseeing product safety is more often based on punishment in the form of recalls or lawsuits for bad products than it is on the creation and enforcement of specific and clearly articulated requirements. While inconvenient, this makes sense. Regulators cannot possibly be expected to guess what products will be invented next. The good news is that there are some people and organizations who can help you find your way.
Industry Trade Association
The trade association serving your industry is a good place to start. Some such as the Juvenile Products Manufacturers Association (JPMA) provide a certification program for certain regulated items within the industry. In fact, a little-known member benefit of JPMA is the availability of John Preston, a retired 25 year staff member from the Consumer Product Safety Commission (CPSC) in the area of standard development for children's safety. He is available by phone at no charge to JPMA members. In addition, Rick Locker is an attorney retained by JPMA to assist members and answer questions in this realm. Rick sums up the process as a "Three Prong Analysis". First, review the Federal standards (CFR's). Second, review the voluntary standards at ASTM International. And third, use common sense as common law is the regulating force here, e.g. lawsuits. For new inventors, it appears that this is the most important of the three prongs.
Federal Safety Standards
The first place to visit is the website of the CPSC where you can link to the Consumer Federal Regulations: Title 16 -- Commercial Practices CHAPTER II -- CONSUMER PRODUCT SAFETY COMMISSION. This is where you can read the Federal regulations that may be applicable to your product. For example, if you have a product that is intended for use by children under the age of 3, you will want to be sure it complies with section 1501 addressing choking hazard test requirements. While some specific regulations are listed here, most products don't have their own Federal regulation. When I asked the person who currently heads children's products at CPSC what an inventor of a truly new item -- one without a regulation or standard-- could do to try to develop safe products, I was told that looking at the past product recalls to see what products and product attributes had caused problems in the past would be one good step. I was also told that a call to the CPSC injury information clearing house would be helpful because I could get data on past product related injuries and consumer product complaints. The information is on their Website under "Library" and then under Consumer Product Related Statistics. Two numbers are listed 800-638-2772 and 301-504-7923. Finally, I was advised to visit the Websites and contact ASTM.
Voluntary Standards organizations and ASTM International
There are approximately 400 voluntary standards organizations in this country. The one mentioned most frequently in this research is ASTM. Based in Pennsylvania, ASTM International is a Not-for-Profit organization that provides a global forum for the development and publication of voluntary consensus standards for materials, products, systems and services. ASTM standards are accepted and used in research and development, product testing, quality systems, and commercial transactions around the Globe. (The Handbook of Standardization, ASTM International). ASTM is not a government body but a membership organization (membership is $75.00). Because of a lack of clear standards for manufacturers to follow, groups of suppliers come together working with ASTM and their methodology, to develop a set of ASTM safety standards for that group. In the absence of anything better, these tend to become the de facto standards used by regulators. Most of the standards produced with ASTM are in categories where there are established suppliers and products; for example, there are 17 ASTM standards in the juvenile industry covering products such as bath seats, cribs, and infant bedding.
To use ASTM, first visit their excellent Website (www.astm.org). Click "standards" and search your category using key words. If a standard exists covering your product, you can purchase it for about $30. When I asked an ASTM representative, "what if I have a new invention such as our TP Saver, that isn't a part of an established category?" His advice was to identify the technical committee(s), listed on the website closest to my item. There are 130 such committees. For me, committee #15 on Child Safety would be a good one to contact. Then contact the staff person listed with that committee who would likely have insight into any standards or regulations for those items or similar items or be able to recommend a member of the committee who might have insights.
Test Labs
Another place to look are independent test labs. There are a number of them in the market and industry trade associations can generally recommend those familiar with a particular industry. When your product falls into one of the categories with clearly defined standards, it is relatively simple to know how to move forward. However, if your item is novel, it is difficult to know what the lab must test. If money isn't an issue, it may be easiest just to go directly to a lab and pay for their guidance. However, in our experience, in the absence of a clear ASTM standard, test labs propose a wide array of tests, some of which may not really be necessary. For this reason, I recommend that you be a good shopper and see what different labs advise.
State Regulations
The Federal regulations cannot be pre-empted by special state laws, however, some states have supplemental enforcements of certain Federal laws. These regulations are difficult to identify and the offices to contact will vary from state to state.
International Standards
International Standards Organization (ISO) is the body which works on global standards. In the juvenile industry, there are no global standards except for toys.
Labeling Requirements
To determine the labeling requirements for your product, you will likely need to follow the same process as you have for the other safety requirements. The trade association, CPSC, voluntary standards and common sense seem to prevail. Additionally, some states will have regulations and another organization, American National Standards Institute comes up. Their voluntary standard, Z535.4 addresses the format of labels such as font size.
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Hi, Tamara.
I appreciate your articles and "The Mommy Inventor's Handbook". Your book was a staple in my business start-up.
My 2 cents on the above issue is one should first visit the Consumer Product Safety Commission website to gain their own understanding regarding regulations and required testing. Thereafter, compile a list of several "CPSC approved" laboratories, soliciting the lab’s professional interpretation of the CPSC regulations, suggestions about one’s own specific product, and lab fees/services. Completion of this process will clarify many questions and shed light on future actions to take, timeframe, cost, etc.
An aside, would be to determine whether the manufacturer already has quality/safety "certifications" for materials used and/or finished product. If a copy of the testing and/or certification can be obtained, this may eliminate one's need for some testing (especially if the manufacturer uses a CPCS approved laboratory). I was able to make arrangements with my manufacturer to receive several product samples in the beginning of the run to iron out any issues before the run in its entirety.
Hope this helps someone.
Best regards
Hi Fred,
Thanks for your post. I agree! It's usually a good idea to speak to an expert if possible.
The above information is great and one of the other resources available is the guidance of a seasoned professional toy and children's products safety consultant. Reviewing all of the regulations is a good place to start but the truth is that a lot of the regulations are not so easy to understand and are open to interpretation. I am a subscriber to the old adage that an ounce of prevention is worth a pound of cure - it is usually very cost effective to spend a little for the expert advice of a consultant up front to avoid the hassle of having to correct a problem after materials are purchased, tooling is built, production is running or your product is already in the hands of consumers.
This is an opportunity to get the benefit of 40 years worth of experience to support your idea and help eliminate any second guessing in product safety and regulatory compliance issues. You will not be disappointed in the user-friendly service I am able to provide.