Food Protection Trends - May/June 2021 - 363

involve a more stringent process than routine sanitization: " It is therefore important that foodservice
establishments have procedures for the cleaning and
disinfection of vomitus and/or diarrheal contamination
events that address, among other items, the use of
proper disinfectants at the proper concentration. "
As stated above, disinfection is not a current regulatory requirement in retail food and foodservice
establishments. However, when a disinfectant is used
on a food-contact surface, special attention must be
paid to the EPA-registered label use instructions (i.e.,
concentration, contact time, and application method),
which typically includes a rinse step after use.
* Concentration verification. In Section 4-302.14, the
concentration of the sanitizer is required to be measured
to be sure it is used at a minimum concentration that
ensures proper sanitization and that it does not exceed
the level above which the sanitizer may not be safe.
Therefore, " a test kit or other device that accurately
measures the concentration in mg/L [ppm] of sanitizing
solutions shall be provided. "
REGULATION OF SANITIZERS AND DISINFECTANTS
The U.S. EPA is the primary regulatory authority for
antimicrobial products like sanitizers and disinfectants used
in retail food and foodservice establishments. Antimicrobial
products are identified as antimicrobial pesticides by the
EPA, as they fit the statutory definition of products intended
to reduce or eliminate microorganisms (7). Various physical
and chemical attributes of sanitizers and disinfectants may
differentiate them in the marketplace. Regardless of these
differences, they all must meet certain regulatory standards
to be legally sold in the United States. The EPA sets minimum
levels of biocidal efficacy (i.e., the ability to reduce or
eliminate targeted organisms under laboratory conditions)
that must be met for a product to be called a disinfectant
or sanitizer (11). Additional organisms can be added to the
EPA-registered product label based on proven efficacy and
shared in the marketing material of individual manufacturers.
In addition, the EPA determines the human and ecological
risks from exposure to antimicrobial products, which results
in statutory precautionary and first aid labelling, including
any personal protective equipment that may be required
when the product is used. The EPA Antimicrobial Division
manages the registration of antimicrobial products used
on inanimate objects, such as sanitizers and disinfectants.
Although not the focus of this paper, there are other
regulated antimicrobial products used in retail food and
foodservice establishments. For example, the FDA, not the
EPA, has responsibility for regulating skin antiseptics (i.e.,
antimicrobial hand soaps and hand sanitizers).
A data package submitted to the EPA for the registration
of an antimicrobial product must include microbiological
data (i.e., efficacy data), chemistry data, stability (or

shelf life) data, and toxicology data (to help determine
precautions and recommendations for personal protective
equipment). The submission must also include a detailed
master label containing first aid statements, precautionary
language directions for use, efficacy claims (often a list
of microorganisms and the contact times and product
concentrations), and suitable marketing claims. The scientific
experts at the EPA not only analyze the data submitted but
make decisions on whether proposed marketing language is
truthful and not " false and misleading. " Product ingredients
are also reviewed carefully. In the case of food-contact
sanitizers, all ingredients (i.e., active and inert) must be
approved for food use, allowing the product to bear a " no
rinse required " use instruction. Disinfectants do not have
this requirement; therefore, disinfectants must be rinsed off
if used on a food-contact surface, and then that same surface
must be sanitized before reuse. If using a detergent-sanitizer
or detergent-disinfectant, rinsing is not required if stated on
the product label (8, 15). The EPA review process can take
up to 4 months for the addition of a new claim or application
and between 5 and 10 months for a new product. It might
take several years if the product has been designed with a
novel active ingredient.
Once the basic requirements have been met (Table 2),
a manufacturer may test and add a variety of additional
microorganism kill claims to the label through the
registration process. Companies manufacturing sanitizers
and disinfectants typically market claims that resonate with
the retail food and foodservice industry (e.g., norovirus,
Listeria monocytogenes, and E. coli O157:H7). Importantly,
only additional bactericidal claims can be added to a sanitizer
label, whereas additional bactericidal, virucidal, fungicidal,
tuberculocidal, and sporicidal claims can be added to a
disinfectant label. It should be noted that many products have
proven efficacy as both food-contact and nonfood-contact
surface sanitizers, in addition to disinfectant efficacy, often
at different concentrations and contact times, so a product
might have a long menu of efficacy claims listed on its master
label. Therefore, it is important to read the label carefully to
understand which claims apply when using the product as a
food-contact surface sanitizer and which apply when using
the product as a disinfectant. The labels of all EPA-registered
sanitizers and disinfectants are listed in a searchable
database available in the EPA Pesticide Product Labeling
System (PPLS) (14) and at the National Pesticide Retrieval
Information System (NPRIS) (1). In addition, to help users
select an appropriate sanitizer or disinfectant to control
microorganisms of interest, the EPA maintains specialized
lists (13). Examples include List G, the EPA's Registered
Antimicrobial Products Effective Against Norovirus, and List
N, Disinfectants for Use against SARS-CoV-2 (COVID-19).
The latter (List N) will be described in greater detail later in
this paper.

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Food Protection Trends - May/June 2021

Table of Contents for the Digital Edition of Food Protection Trends - May/June 2021