 Hello and welcome to this presentation about the Federal Hazardous Substances Act, or FHSA presented by the Office of the Small Business Ombudsman at the Consumer Product Safety Commission. This presentation was prepared by CPSC staff and may not necessarily reflect the views of the commission. In this presentation, we will go over the specific hazards that are listed in the FHSA, as well as the labeling requirements that your product may require. We'll also briefly discuss what happens to products as they enter the US ports. We'll discuss product recalls and the best practices for your business. Throughout this presentation, there will be a series of poll questions. If you are watching this presentation in YouTube, this is not interactive, but we will take a brief pause so that you can think about what you think the correct answer is. We'll go through those answers with you as well. So our first poll question to start off this presentation. True or false, products requiring labeling under the FHSA automatically require a general certificate of conformity or GCC. The answer to this is false. FHSA labeling does not require documentation in a GCC. However, if your product also requires special packaging under the PPPA or Poisoning Prevention Packaging Act, that product will require a GCC. So what is the FHSA? This act requires cautionary labeling of hazardous household substances intended or packaged for household use. It informs the consumers of safe use and storage and provides consumers with immediate first aid steps. So that if you have a product that contains one of these potential hazards, the consumer has the information that they need to protect themselves and any children that may come in contact with it. As a manufacturer or importer of one of these products, you must ensure that your products are either labeled as hazardous or that they are not hazardous. The FHSA also bans products intended for children that are or contain hazardous substance that the child could access. And then it allows the commission to ban certain hazardous products where labeling is not adequate. So with all of that CPSC must apply the least burdensome option that adequately addresses the hazard and consider the costs and benefits of any of these remedies. The FHSA applies to consumer products for household use. There are several categories which are specifically exempted from this requirement, including anything that is under the jurisdiction of the FDA, which would include drugs and cosmetics, as well as pesticide products that are under the jurisdiction of the EPA. The entire text of the FHSA can be found through our website and we'll include a link to that at the end of this presentation, as well as ecfr.gov. And some specific sections to pay attention to 16 CFR 1500.40 to .46. This is where we provide test methods to determine whether the substance or mixture is a hazardous substance. There is also a statement on animal testing policy in 1500.232. And then the actual labeling guidelines, if your product does require labeling, are in 1500.121. This outlines the general requirements for a label, including the prominence, placement, and conspicuousness of that label to ensure that the consumer can see it. So what is a hazardous substance? This is defined in the act as something that is toxic, corrosive, and irritant, a strong sensitizer, flammable or combustible, or generates pressure through decomposition, heat, or other means. And it has the potential to cause substantial personal injury or illness during or as a result of any customary or reasonably foreseeable handling or use. And this includes reasonably foreseeable ingestion by children. So it has to meet both of those requirements. It has to have one of these hazards present, and it has to have the potential to cause an injury or illness or death. Okay, for our next poll question. True or false, the FHSA applies to both acute and chronic hazards. This is true. So if you view the Code of Federal Regulations under 16 CFR 1500.3C2, this discusses the requirement for assessing your product for chronic hazards. So chronic hazards, they include but not are not limited to cancer developmental toxicity, which is birth defects, reproductive toxicity and neurotoxicity. So these are the types of hazards that can result from a long term exposure as opposed to acute hazards which result from short term exposure. The FHSA is risk based. So consider that your labels must consider both toxicity or another hazard and the exposure, potential exposure. We do have a chronic hazard guideline to assist manufacturers in complying with the FHSA, which you can access through this link here on our website. So now we'll discuss each of these specific hazards in more detail, the first of which is the term toxic. The definition of this is that a toxic is a substance other than a radioactive substance which has the capacity to produce personal injury or illness to any person through ingestion, inhalation or absorption through any body surface. Some common chemicals which could be considered toxics are sodium hydroxide or potassium hydroxide, oxalic acid and products which may require labeling include cleaning products, drain cleaners and wood conditioners. For our next poll question. My product has a lethal dose or LD 50 of greater than five grams per kilogram. Does it require labeling as toxic? So the answer is no products with an LD 50 of greater than five grams per kilogram are not considered toxic and this is specifically discussed within the FHSA. Our next term is corrosive. The definition is that a corrosive means any substance which in contact with living tissue will cause destruction of tissue by chemical action, but shall not refer to action on in and in its surfaces. You can see here some common corrosive chemicals which include hydrochloric acid, sodium hydroxide, calcium oxide, sodium hyper chloride, chlorine and ammonia. And common products which may require labeling are bleach cleaning products and pool chemicals. Next term is an irritant. An irritant is a substance which is not considered a corrosive, but which on immediate prolonged or repeated contact with normal living tissue would induce a local inflammatory reaction in any human subject. And common chemical irritants include glycol ethers, nominal fennel and sodium laurel sulfate and products which may require labeling include cleaning products and dies. Our next term is strong sensitizer. A strong sensitizer is a substance which will cause a normal living tissue through an allergic or photodynamic process, a hypersensitivity which becomes evident on reapplication of the same substance, and which is designated as such by the commission. So strong sensitizers don't necessarily affect every single person who has an exposure to the substance. It's only certain individuals who may have an allergic reaction. You can read about the common chemicals that are specifically labeled as strong sensitizers in section 1500.13. And some products which may require labeling include essential oils, multi-purpose cleaners, potpourri and fabric dies. So our next poll question, human exposure data shows my chemical formula produces an allergic reaction in 5% of human subjects. What signal word should I include on the label? Based on this limited information provided, this product is likely a strong sensitizer. You may have thought this product was an irritant because it had a reaction on human subjects. However, an irritant is an agent that is capable of producing cell damage and or an inflammatory response on any individual if applied for sufficient time and concentration. Whereas in this example, only 5% of the human subjects had this reaction. So we would consider this a strong sensitizer and not an irritant. Our next terms are flammable or combustible. There are three specific definitions for this in the act. The first is extremely flammable, which has a flash point at or below 20 degrees Fahrenheit. Flammable, which is a flash point above 20 degrees Fahrenheit and below 100 degrees Fahrenheit and combustible, which has a flash point at or above 100 degrees Fahrenheit to up to and including 150 degrees Fahrenheit. Common chemicals include isopropyl alcohol, ethanol, xylene and acetone. And some products which may require labeling include spray paints, adhesives, sealant chemicals and solvents. Our next poll question, does nail polish remover require labeling under the FHSA? And that we're assuming this nail polish has a flash point of negative four degrees Fahrenheit. The answer is no, nail polish remover is regulated as a cosmetic by the Food and Drug Administration. So this substance is specifically exempted from the FHSA requirements and would not require labeling. If this product were a general cleaner and not a cosmetic, it would require FHSA labeling as extremely flammable because of that flash point, which is at or below 20 degrees Fahrenheit. The last term is generate pressure and a substance or mixture of substances that generates pressure through decomposition heat or other means as a hazardous substance if one of the four conditions are true. First, if it explodes when subjected to an electrical spark, percussion or the flame of a burning paraffin candle for five seconds or less. If it spells the closure of its container or bursts its container when held at or below 130 degrees Fahrenheit for two days or less. If it erupts from its open container at a temperature of 130 degrees Fahrenheit or less after having been held in the closed container and 130 degrees Fahrenheit for two days, or if it comprises the contents of a self pressurized container. Some products which may require labeling include aerosols, fireworks that contain explosive powder and certain pool chemicals. The FHSA goes into more definition of each of these categories, including defining oral, dermal and inhalation toxicity, corrosivity, skin and eye irritation, flash points and what a flammable cell it is. When considering your potential need to label under the FHSA, an evaluation should be specific to an individual product formulation because very small changes in your product chemistry can have very large impacts in the hazard or potential impact to human health. So some things to consider are the method and severity of injury. How likely an accidental exposure during use and handling is what the duration of that exposure might be and the quantity of that exposure and the recommended handling use and storage of that product. So if you've determined that your product does require labeling under the FHSA, your next question might be what information must I put on the packaging of a hazardous product. Several labeling requirements are included in 16 CFR 1500.121 and their requirements for the principal display panel or PDP and for somewhere else in the packaging, either on the PDP or on the side or back panel. The PDP must include the signal word, which says danger, warning or caution, or it may also include poison for highly toxic substances and caustic poisons. It must include an affirmative statement of the principal hazards, for example, flammable, harmful if swallowed causes burns. And it must include a statement to read the other cautions on another panel if all information is not on the principal display panel and on the principal display panel or on the side or back panel. It must include the name and place of manufacturer, hacker, distributor or seller. The common or usual name or chemical name of the responsible substance that is bringing this potential danger. Any precautionary measures to follow. Instructions for first aid treatment. Instructions for safe handling and storage. And then finally keep out of the reach of children or its practical equivalent. In the following slides, we have some examples of labels for products which require FHSA labeling. But please note that these are just examples and your product, even though it may contain similar chemicals. These are very specific to each chemical formula and we should not generalize the hazards. Here's an example for the principal display panel for oxalic acid at a concentration of 10th or more. The principal state's poison may be fatal if swallowed contains oxalic acid at 10% or greater concentration. See back panel for first aid information and keep out of the reach of children. And here is an example of what would be not on the necessarily the principal display panel but somewhere else in the packaging. This is the first aid instructions. Which include information for eye exposure, skin exposure, inhalation or ingestion for if swallowed. And we do recommend, you can see here if swallowed immediately call a poison control center or doctor. We do recommend putting the number for poison control directly on the packaging so that the consumer does not need to do additional research to to get that phone number. And we do recommend that you also include your toll-free number for consultation if there is any sort of exposure so that the consumer can call directly and get the best information for first aid instructions. So here's another example of first aid instructions. And these would be generally for acids, alkalis, petroleum distillates or cationic detergents or surficants. There's a lot of the same information here as in the first example, but there's a little bit more detail about what sort of treatment to give the individual who was exposed. And again, we do recommend putting the number for poison control directly on the packaging because that's often a great resource for people dealing with an accidental exposure. So CPSC staff does not perform pre-market approval of labels or design labeling for products. However, staff can provide an informal label comment if a firm submits their complete quantitative formula, their proposed label, and adequate pharmacological, toxicological, physical and chemical data that indicates the possible hazards that the product may present. You can email these directly to regulatedCMT at CPSC.gov and they will review that information and provide an informal label comment to you. Keep in mind that the Consumer Product Safety Act or CPSA and FHSA make it unlawful to introduce or deliver for introduction a misbranded banned hazardous substance, manufacture, distribute, import, sell or offer for sale any part that does not comply with the mandatory standard of which the FHSA is considered a mandatory standard. Fail to report as required by section 15B or fail to report under section 37. So section 15B that has to do with injuries that you are made aware of and you can report those through saferproducts.gov. And section 37 of the CPSA has to do with legal action that is taking against your company. And the full text of the CPSA is also available on our website if you want to learn more about these requirements. So you may be wondering if the FHSA is in harmony with the globally harmonized system or GHS for labeling your consumer products. And at this time it is not. However, we do allow for dual labeling. Just keep in mind that the FHSA text must be kept separate and the GHS label must not contradict FHSA cautionary statements. So what would happen if your product fails to comply with these FHSA labeling requirements? Unfortunately, we have had violations in the past and these are some examples of products that were seized at US ports for failing to meet the Federal Hazardous Substances Act requirements. These include detergents, cleaners, paint removers and strippers, blues, automotive chemicals, air fresheners, sealants, mineral spirits, degreaser and antifreeze. So these products had some sort of FHSA violation that they required labeling and they did not have it or they did not have the adequate labeling or they did not have the labeling in English as required. Many staff are positioned at different ports throughout the country to inspect consumer products when they come in from overseas. And this diagram explains the potential scenarios that your product could go through. Hopefully your product is meeting all mandatory requirements and either would not require an exam or pass its exam and can go directly into commerce. But if there's any sort of issue with that product, either the labels are not there or they're inadequate. They potentially could have your product detained and destroyed if you are unable to fix that violation. So as a best practice, we always recommend to be aware of the requirements and ensure that you're meeting all of those mandatory standards before filing or entry of your products into the United States. True or false. I can fix my FHSA label at my domestic facility after I have imported the finished product. All CPSC requirements must be satisfied for your finished product prior to entry into the United States. Failure to comply can result in seizure and destruction of your products. We do recommend that if you are importing products to work with a licensed custom broker, they can help you to determine which paperwork you need to file and that your entries are coded correctly so that you are less likely to run into any issues when importing that product. Next we will be discussing recalls. A recall is a generic term used to describe a corrective action under section 15 of the CPSA and may include some or all of the following. You may be asked to stop production distribution of the product, stop retail sales, prepare the product, provide a replacement or refund to your consumers or provide a notification to your consumers. I'm curious what has gone into previous recalls in the past or what products have been recalled. You can search at www.CPSC.gov forward slash recalls. Next poll question I received a report from a consumer of my product causing an eye injury. What should I do. We have several options here. If my product is properly labeled under the FHSA I do not need to document product injuries. Our second option is keep an internal record of this complaint but do not report it outside of the company. My third option is to submit a report to CPSC through safer products.gov. The correct answer is number three submit a report to CPSC through safer products.gov. So saferproducts.gov is where you can sign up for an account through our business portal and this is where you should report any potential consumer injuries that you've been made aware of within 24 hours of receiving that complaint. Some best practices. We really recommend to make safety a priority at the design stage of your product. You're going to want to identify potential hazards and assess those risks. Remember how your consumer might use or potentially misuse that product and then eliminate, guard against or warn users of those identified risks. So the FHSA is really intended to warn those users before they purchase the product. They can be made aware of the potential hazard and make a decision about purchasing a product at that point. You're going to want to ensure that your product meets or exceeds the requirements in any voluntary industry consensus standards. You want to build safety into your supply chain and have good relationships with your suppliers. You also want to be knowledgeable of the regulatory environment. You can keep up with updates to CPSC rulemaking by subscribing to the SBO newsletter, which is available through our website. You should also have a recall plan in place in the event that you need to act quickly if there's an issue with your product. And finally, we do recommend using lot or batch controls or serial numbers to identify products under each manufacturing batch. This will allow you to target specific products, which may have an issue instead of your entire product line. Here we have some helpful resources for you, some of which I discussed during the presentation. And we also have the contact information for this office. The Office of the Small Business Ombudsman or SBO can be reached at SBO at CPSC.gov. Or you can leave us a voicemail at the phone number 301-504-7945. If you would like an informal label comment, you can contact the chemical compliance team. And their email is regulated cmt at CPSC.gov. And the helpful links that we have listed here, the homepage for our website is at www.cpsc.gov. There's also a link to our business guidance page for the FHSA. We also host the full text of the FHSA on our website, as well as those chronic hazard guidelines that I discussed earlier in the presentation. And finally, if you're unsure where to start, we do recommend looking at our regulatory robot, which is available at business.cpsc.gov. And this is a smart system which asks you a few questions about your product and then gives you the potential mandatory federal regulations for testing, labeling and certification that may be required. Thank you very much for watching this presentation today. We hope that you found it informative. If you do have additional questions, we strongly encourage you to reach out to us directly again at that email address SBO at CPSC.gov or the phone number 301-504-7945. Thank you.