What are antimicrobial pesticides and how are they regulated?
The U.S. Environmental Protection Agency (EPA) regulates antimicrobial pesticides separately from conventional pesticides and biopesticides. The Antimicrobials Division of EPA is responsible for reviewing and approving antimicrobial pesticide products that are offered for sale in the United States. Antimicrobial pesticides are substances or mixtures of substances that prevent, destroy, repel or mitigate microorganisms on inanimate objects and surfaces. The regulatory landscape associated with antimicrobial products can be confusing. Depending on the formulation of the product, uses and label claims, the product may be exempt from federal regulation, it may be regulated by either EPA or the Food and Drug Administration (FDA), or it may be regulated by both agencies.
How are antimicrobials and related products categorized?
Antimicrobial-type products can be categorized and regulated in many different ways depending on various factors. Companies need to clearly understand their product type in order to ensure compliance with the associated regulations. This includes determining the difference between cleaning products and pesticides, whether the product is regulated by EPA, FDA or both, or if there is an exemption from registration (e.g., pesticide devices) and the types of efficacy data that would be required to support an antimicrobial product approval.
Cleaners vs. Antimicrobial Pesticides
EPA regulates products that prevent, destroy repel or mitigate microorganisms. These types of antimicrobial pesticides include public and non-public health products that claim to control spoilage, reduce odor, destroy fungus or sterilize, disinfect or sanitize any surface, material or some water systems. EPA does not regulate cleaning products that claim to clean, shine or whiten surfaces or materials.
EPA-Regulated Non-Public Health Antimicrobials
EPA regulates antimicrobials that are considered non-public health antimicrobials. These types of antimicrobials control the growth of microorganisms, such as algae and odor-causing bacteria, bacteria that cause spoilage, deterioration or fouling of materials, and microorganisms that are only infectious to animals. Examples of non-public health uses include antimicrobials used in cooling towers, paints, jet fuel and treatment for textiles and paper products.
EPA-Regulated Public Health Antimicrobials
Antimicrobial products that are intended to control microorganisms infectious to humans in any inanimate environment are regulated by EPA as public health antimicrobials. These products include sterilizers, disinfectants and sanitizers. Examples of public health uses include antimicrobials used in hospitals, institutions, schools, industrial settings and homes.
EPA- vs. FDA-Regulated Antimicrobials
EPA regulates products that control microorganisms on inanimate objects and surfaces. FDA claims jurisdiction over products that are intended for use on critical and semi-critical medical devices, products with claims to control pathogens in or on humans or animals (e.g., antiseptics and germicides), and products used in or on raw agricultural commodities, processed food and food contact articles.
Pesticide devices are instruments or contrivances that destroy, repel or mitigate microorganisms. EPA regulates – but does not register – devices. Devices must comply with labeling, reporting and recordkeeping requirements. While EPA does not register devices, a select number of states do require the registration of devices.
EPA requires the registration of material preservatives used to treat articles in order to protect against microorganisms (bacteria, fungi and viruses). These treated articles are regulated by EPA but do not require registration; however, it is important to ensure that product and marketing claims do not trigger a pesticide classification.
Companies continue to develop novel technologies to address public health concerns. Many of these technologies do not have a clearly defined path to regulatory approval, which means that there are many options – and challenges – in bringing a novel technology to market. TSG has been the lead consultancy in some of the most novel technologies on the market today, and has expertise in developing regulatory and data development strategies, negotiating with EPA and serving as an advocate on behalf of our clients with the Agency.
What are common antimicrobial products?
Sterilizers are intended to destroy or eliminate all forms of microbial life, including fungi, viruses, bacteria and their spores. Sterilization is critical to infection control and is widely used in hospitals and medical settings.
Disinfectants are intended for use on hard inanimate surfaces and objects to destroy infectious fungi and bacteria but not necessarily their spores.
Sanitizers reduce, but do not necessarily eliminate, microorganisms from the inanimate environment to levels considered effective. They include food contact and non-food contact products.
Antiseptics and germicides prevent infection and decay by inhibiting the growth of microorganisms. They are regulated by the FDA because they are used in or on living humans or animals.
How can TSG help me?
TSG helps guide companies through the design and implementation of registration strategies to obtain approval and maintain compliance of traditional and novel antimicrobial products. TSG is actively involved in industry associations for these product types and sits on the Board of Directors for the Consumer Specialty Products Association’s (CSPA) Antimicrobial Division and American Chemistry Council’s (ACC) Biocides Panel. TSG also manages the Silver Task Force North America, Zinc Task Force North America and provides technical advice for the Copper Development Association. Additionally, two of TSG’s consultants were recipients of CSPA’s 2013 Volunteer Recognition Award, which honors outstanding service to members who dedicate their time, effort and talent towards the advancement of CSPA’s goals.
The regulatory landscape for antimicrobial products is ever changing. EPA continues to release new efficacy standards and test methods as well as revise or, in some cases, reverse its opinion on label claims and evolving technologies. Novel antimicrobial technologies may require building consensus with EPA to develop appropriate testing methodologies and corresponding label claims. In this changing climate, TSG’s significant experience and expertise can make the difference for companies trying to successfully navigate and succeed in bringing their products to market in the most cost-effective and timely manner possible.
TSG’s antimicrobial services include:
▲ Development of EPA/state Registration Strategies
▲ Negotiation of data requirements
▲ Designing and monitoring regulatory studies
▲ Preparing risk assessments
▲ Developing product labels
▲ Preparation and submission
of federal and state registration applications
▲ Advocacy with the regulatory agency for successful registration,
We have significant experience in:
▲ Data development
▲ Good Laboratory Practice (GLP) compliance
▲ Efficacy study design
▲ Interpretation of data results
We also assist in the preparation of:
▲ Data waiver rationales
▲ Human health risk assessments
▲ Environmental risk assessments
▲ Label amendments
▲ New inert ingredient petitions
Contact TSG to learn how we can help.