Whether you are a facility manager, business owner or consumer, it can be difficult to grasp the whirlwind of guidance from agencies like the Centers for Disease Control and Prevention (CDC) and the Environmental Protection Agency (EPA). These agencies consistently update guidelines and lists of approved cleaning and disinfecting products, but with so much information available, how can you determine which are best for your facility or home?
There has been an increase in marketing claims stating a product is “approved” or “registered” – but what do these claims mean? As the Director of Scientific Services at PathoSans, I am increasingly asked how to navigate the numerous government agencies involved in manufacturing, distributing and selling cleaning products. Read on to learn the key differences between these agencies and why this information matters.
The Three Major Players
With any virus, like SARS-CoV-2, which causes COVID-19, you want to eradicate it to prevent it from spreading. This requires cleaners, sanitizers, disinfectants and application technologies that are regulated by various government agencies. Without this oversight, more unsafe or toxic chemicals could proliferate in the market and end up harming those who conduct cleaning and those who occupy and reside in facilities like schools, office buildings, airports and more.
The ecosystem of government agencies is complex given that they can overlap in their roles at times. Below is a simplified snapshot of how this works with cleaners and disinfectants. I’ll highlight three key agencies in more detail as well.
The CDC’s mission is “to protect America from health, safety and security threats, both foreign and in the U.S.” It serves as an information source and advisor to provide guidance about human health.
The agency can assess fines or issue a mandate, like requiring masks be worn on commercial flights. However, the requirement is enforced by the Transportation Security Administration (TSA) or other federal, state and local agencies. CDC “guidelines” serve exactly the purpose their name suggests – as guidance to other government agencies and the general population based on their findings.
It is important to distinguish between the EPA, an independent agency that regulates products like antimicrobials that are used around people, and the Food and Drug Administration (FDA), which focuses on products that go on or in people. A particular product or chemistry may require EPA and/or FDA approval, depending on its use. For example, a sanitizer or disinfectant used on hard, non-porous surfaces is regulated by the EPA. A sanitizer or disinfectant used on the body, like hand sanitizer, is regulated by the FDA.
The EPA also regulates antimicrobial substances used to destroy or suppress the growth of harmful microorganisms on surfaces, whether they are bacteria, viruses or fungi. Finally, the agency examines “inert ingredients” – chemicals, compounds and other substances found in some disinfectants, often to produce a fragrance or extend shelf life.
Another question I am asked frequently is, “What does it mean if a product is EPA-registered?” The EPA grants a “registration” or license that permits a disinfectant’s distribution, sale and use only after the company meets specific scientific and regulatory requirements. For more information on what it takes to become a registered product see, access the EPA’s guide. A product must be registered with the EPA to make a “kill claim” regarding pathogens of concern.
Becoming registered requires a review by the certifying body and an official acceptance by the agency. Then, the label becomes law. In the case of the EPA, this approval is for bottled chemical products, not the means to make a chemical product. So, a disinfectant like hypochlorous acid can be registered, but the on-site generators that produce it typically are not.
- Kill Claims for SARS-CoV-2
The EPA will not register a product claiming to be effective against the SARS-CoV-2 virus until the agency determines that the product will not pose an unreasonable risk and will be effective when used according to the label directions. The EPA maintains List N, a list of disinfectants that meet its criteria for use against SARS-CoV-2.
However, due to logistical difficulties associated with performing tests on this virus, especially when it was first emerging, the EPA decided to accept products that had been proven effective against harder-to-kill viruses after an expedited review process. Therefore, List N contains both products that the EPA “expects” will kill SARS-CoV-2 when used according to the label directions and those directly tested against the virus.
The CDC recommends practices like handwashing and sanitizing, but it is up to the FDA to make sure products for these purposes are safe and effective. Officially, the FDA is “responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics and products that emit radiation.”
As mentioned, the FDA is concerned with products that go in and on you, such as hand sanitizers, antiseptic washes and antibacterial soaps. In fact, the FDA considers sanitizers as over-the-counter drug products. According to FDA Specialist, a consultancy made up of former FDA officials, manufactured or imported sanitizers must comply with these FDA requirements:
- National Drug Code (NDC) is the FDA’s identifier for drugs. The FDA publishes NDC numbers in the NDC Directory. Any establishment that manufactures, repacks or relabels hand sanitizer must be registered with the FDA as a drug establishment. Companies that only import the hand sanitizers (and do not manufacture, repack or relabel the product) do not need to register with the FDA.
- Good Manufacturing Practices (GMP) is how the FDA ensures the quality of the drug by carefully monitoring drugmakers’ compliance with design, monitoring and control of manufacturing processes and facilities. Registered establishments must list the drug with the FDA.
- Labeling Compliance – The FDA has strict requirements for all products sold or distributed under its jurisdiction. The labels of hand sanitizers must comply with all FDA drug labeling requirements, which include having a properly declared statement of identity, net quantity of contents, name and place of business, expiration date and a Drug Facts panel. The panel must state the active ingredient(s), uses, warnings, inactive ingredients, purpose and directions.
Keep in mind that FDA regulations and guidance can change as conditions change. For example, due to the COVID-19 public health emergency, the FDA has established a temporary policy under which the agency will not take enforcement action against companies that manufacture alcohol-based hand sanitizers if they comply with certain requirements around ingredients, concentration, labeling, establishment registration and drug listing.
Understanding a Complex Web
As much as people may complain about the burden of government regulations, the CDC, EPA, FDA and other federal agencies are diligently looking out for public safety. The FDA and EPA responded to the SARS-CoV-2 pandemic by ensuring the availability and safety of sanitizers and went to great lengths to expedite the availability of COVID-19 vaccines. The CDC’s guidance throughout the pandemic helped businesses and individuals react appropriately to the extraordinary circumstances with science-based best practices.
A large part of my job is to secure laboratory testing, assure it is compliant and submit it for various approvals, so I am familiar with the intricacies of many regulatory agencies. The web of regulations around cleaning, sanitizing and disinfecting products is complex, but the ultimate goal of federal oversight is to protect public health. That is a goal we can all get behind.
Have other important questions or need further clarification on the above? Would you like to learn about this topic further via a webinar, video or some other format? Contact me at Tyler.Williams@spray.com to share your questions and thoughts.
Tyler Williams is Director of Scientific Services at PathoSans, a leading provider of on-site generation (OSG) devices that produce ready-to-use, highly effective cleaners and sanitizers known as electrochemically activated (ECA) solutions. To learn more about effective cleaning and disinfecting solutions compatible with electrostatic technology, visit www.pathosans.com.