Regulatory Q&A

TripleTake Q&A with Lorraine Gallagher

3 Questions, 3 Answers with subject matter experts on relevant, trending topics.

Lorraine Gallagher, Corporate Legal, Regulatory Compliance Counsel PDI R&D

Lorraine Gallagher

Corporate Legal, Regulatory Compliance Counsel PDI R&D

Lorraine Gallagher is the Regulatory Compliance Counsel of Professional Disposables International, Inc. (“PDI”) and its sister company, Nice-Pak Products (“Nice-Pak”). For over 6 years, she has been advising PDI, Nice-Pak and Sani Professional on regulatory issues involving the FDA, EPA, FTC, CPSC and many other government agencies.

In the age of COVID-19, it's essential that foodservice operators make educated decisions about the sanitizing and disinfecting products they purchase and use. But understanding the EPA's List N criteria and what to look for on a Master Label can be confusing. In this TripleTake Q&A – three questions, three answers with subject matter experts on relevant, trending topics – Corporate Legal, Regulatory Compliance Counsel LORRAINE GALLAGHER demystifies how the EPA approves products for use against emerging threats, what to look for when selecting a disinfecting product, and how EPA registrations differ from state to state.

1. What is the EPA’s List N and how would a product get onto this list?

EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19) is part of the EPA’s Emerging Viral Pathogen Program. The intention of the program is to provide suitable disinfectants to use against new or not widely spread pathogens while testing is completed to confirm efficacy of products against that pathogen. The EPA creates a list for new pathogens. For example, List L applies to products that may be effective against the Ebola virus, while List N is for SARS-CoV-2. The EPA determines which disinfectants may be effective based on an established hierarchy of pathogens. Companies submit data to the EPA to demonstrate they meet the criteria for the program. Then, when an emerging pathogen is identified, the EPA releases a new list based on the data submitted by companies.

2. What areas of an EPA Master Label should operators focus on when selecting a sanitizer or disinfectant?

There are a few key data points to consider when selecting an appropriate sanitizer or disinfectant. This information is found on the master label which is stored on the EPA’s website at Pesticide Product and Label System. First, look at the directions for use to determine if the product is a sanitizer or disinfectant (or both) and whether a potable water rinse is required when using on food contact surfaces. Second, look at the organisms the product can kill. For food establishments, some important ones may include Listeria monocytogenes, Escherichia coli, Norovirus, Salmonella and Clostrioides difficile. Third, look at the contact time required for the product to kill the pathogen. This can range from 15 seconds to 10 minutes. Fourth, determine if any personal protective equipment is required to use the product. This can include gloves and eye protection for some products. Finally, look for the use sites to determine if the product can be used on the surface you are sanitizing or disinfecting.

3. Briefly, how do federal EPA registrations differ from state registrations and what are the benefits of using products registered in all 50 states?

Each disinfectant and sanitizer must be registered by the federal EPA. Each company must submit test data to the EPA for review before the product can be approved for use. Once that is complete, the product must also be registered in each state where it will be distributed. The states will examine the product label to determine if it complies with the master label approved by the EPA. The states do not require separate test data, although there have been instances where some states may question claims that are made on the label. A product that is not registered in a state cannot be transported through that state. So, for instance, if a product is EPA registered is manufactured in Massachusetts and registered in Massachusetts and Pennsylvania, but not registered in New York, it cannot be driven through New York to reach Massachusetts. Also, with today’s internet-based business, it is difficult to determine who is ordering the products, so registering in 50 states avoids having to turn down sales.

Lorraine is a member of the Sani Professional® Food Safety Advisory Council (SPFSAC). SPFSAC was established to bring together a peer group of food safety subject matter experts committed to sharing their expertise with the industry.

This snapshot underscores the need for foodservice operators to understand how sanitizing and disinfecting products are registered by the EPA and the states and what to look for when making disinfecting product choices.

For more information and COVID-19 resources, visit the Sani Professional COVID-19 resource center.