United States Biocidal Services
In the US, any products making biocidal, antimicrobial or antiviral claims are subject to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and must be registered with the Office of Pesticide Programs (OPP), an office of the Environmental Protection Agency (EPA), prior to entering US commerce. Pesticides are registered depending on their usage, including general use, restricted use, experimental use, and/or emergency exemptions/ special local needs.
When registering a pesticide, the manufacturer (or importer) is required to provide information to the EPA relating to the pesticide ingredients, toxicity, intended usage, labelling, and potential damage to the environment and humans.
In addition to the product registration requirements, companies involved in the manufacture of Active Ingredients and/or End-Use Products are required to complete a one-time company registration with the EPA. Furthermore, each entity that manufactures or processes pesticides must submit an Establishment Registration per site, whether foreign or domestic.
Note: that anti-pest products intended to be applied to humans (e.g., hand sanitizers) fall out of the scope of FIFRA, and are instead regulated by the US Food and Drug Administration (US FDA).
If you require further assistance please contact us here.
Which services do we offer:
Biocides scoping assessments & registration ‘roadmaps’
End-use product registration assistance
Claim Substantiation
Efficacy & Endpoint testing
Hot Topics:
In September 2021, the EPA finalised a new rule on chlorpyrifos, a widely used pesticide that has been linked to developmental disabilities in children. On February 28, 2022, the EPA's de facto ban on chlorpyrifos use in food or feed crops formally went into effect.
As of 9 February 2023, there are over 100 bills affected by PFAS at the state level, up to now 12 are removed from the current list of inert ingredients previously approved for use in pesticidal products. In Maine, as of January 1, 2023, a notification must be submitted by the manufacturer for any product (including pesticides) containing intentionally added PFAS.
At a trade association meeting in early 2023, EPA announced new additional guidance to be published later in 2023 regarding air sanitizers. EPA clarified that pesticide devices are not permitted to make claims of being an “air sanitizer” even when they are performing similar functions. There are new requirements regarding pesticide devices at the state level. California Air Resources Board (CARB) has specific requirements for ozone-producing devices and requires a certification for all portable air-cleaning devices. Colorado has started requiring safety information for ozone-producing devices.
Guidelines are likely to include further information on protocol development and submission requirements for spray air sanitizers, air sanitizers delivered through devices and pesticide-coated air filters.
On March 15, 2023, EPA announced Accelerated Action on Four Organophosphate Pesticides Based on Updated Exposure Assessments– diazinon, ethoprop, tribufos and phosmet. The assessments are published several years before schedule and due to the urgent nature of action, there will be no comment on published assessments. The Agency is asking the registrants to submit label amendments that reflect the necessary risk mitigation measures for each of these four organophosphates and is prepared to expedite label reviews to implement the protections as quickly as possible.
More details can be found on the EPA’s website: Click here