Antimicrobial Product Labels and Regulations
By Marcia Ellis and Kirsten Buck
Antimicrobial products, whether they be hard surface disinfectants or skin care products, are essential in infection control. It is important for the infection control practitioner to understand the label information and regulations governing that information to choose appropriate products to use in their facility.
The Environmental Protection Agency (EPA) is the government agency that regulates pesticides, which not only includes insecticides, but also germicides. The EPA is responsible for the safety and effectiveness of disinfectants used on environmental surfaces.
The Food and Drug Administration (FDA) is the government agency responsible for safe and effective products used in the healthcare setting. This includes, but is not limited to, skincare products such as surgical site preparations, surgical scrubs, and healthcare personnel hand wash products.
High-level disinfectant/sterilant products such as glutaraldehyde and peracids, although they are disinfectants, are regulated by the FDA because they are considered accessories to medical devices. In order to make the dual jurisdiction work, the EPA and FDA have developed a Memorandum of Understanding (MOU) to define each agency's role and the interaction between the agencies.
A lot of work goes into an EPA-approved disinfectant label. Depending on the product and type of active ingredient, it may take from six months to a year before a label is approved. The EPA registration number on the label consists of at least two sets of numbers divided by a hyphen (e.g., 12345-67-8910). The first set identifies the registrant (e.g., 12345). The second set identifies the specific product formula (e.g., 67). The third set, if present, identifies the supplemental registrant of the formula, meaning that the product is being sold by a company other than the registrant (e.g., 8910).
The end-use product registration package for a disinfectant must contain three types of data: chemical characterization, antimicrobial efficacy, and toxicity. The label information is derived directly from this data1
The chemical characterization data assures product stability, packaging compatibility, and supports the active ingredient statement in area one of the front panel of the label. The toxicity information supports area two: Precautions--Statement of practical treatment (first aid) if contact occurs. This area of the label includes signal words such as "danger/poison" or "caution" to alert the user to special handling precautions. This section also includes a list of environmental hazards, precautionary statements (including personal protective equipment), chemical and physical hazards.
Efficacy studies provide the information in area three of the label: Directions for use--sites of application (hospitals, schools, bathrooms). The dilution directions, contact time, temperature, organic challenge, and hard water challenge are documented as part of the efficacy study. To obtain a claim as a hospital disinfectant, the product must be tested against Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa. Additional bacteria, as well as fungi and viruses, can be added to the label with supporting data under the same conditions as the hospital disinfectant test.
Area four of the label indicates storage and disposal instructions, including the disposal of residual antimicrobial product and the disposal of the empty container.
The APIC Guideline for Handwashing and Hand Antisepsis in Health Care Settings is an excellent tool for selecting an appropriate antiseptic product to achieve the best infection prevention possible.2 Product literature, such as a research bulletin, is also very helpful for indications of product-specific antimicrobial efficacy. Research on the final formulation of a handcare product is especially helpful, as the activity of the antimicrobial is sensitive to change in formulation. Detergents, emollients, and other ingredients can reduce or enhance the antimicrobial efficacy of the active ingredient.
Antiseptic skin care products should include the active ingredient and percentage in the formula. In the US, the product should have a national drug code number (NDC number), which consists of ten digits with three sections. The first section represents the manufacturer, the second identifies the products, and the third indicates the package size. DIN numbers, or drug identification numbers, are assigned by Health Canada for any antimicrobial, including disinfectants. These numbers are assigned sequentially.
In 1978, the FDA published the first Tentative Final Monograph (TFM) for Over-the-Counter Drugs Generally Recognized as Safe, Effective, and not Misbranded.3 The latest revision of this document was published in 1994, titled "Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products." This document serves as the proposed rule by which the FDA will evaluate the safety and effectiveness of all antiseptics.
In this proposed regulation, each antimicrobial active ingredient is assigned a classification ranking based on the availability and review of manufacturers safety and efficacy data. Each antiseptic application type (healthcare personnel handwash, antiseptic handwash, patient preoperative preparation, surgical hand scrub) required defined antimicrobial efficacy data. This data typically includes in vitro tests, such as time kill and Minimum Inhibitory Concentration (MIC) as well as in vivo clinical evaluations.
The TFM, because it is not finalized, is used as a guideline by manufacturers. In 1994, a coalition was formed through a cooperative effort of the Soap and Detergent Association (SDA) and the Cosmetic, Toiletry and Fragrance Association (CTFA). This coalition has proposed a new model for the classification of topical antiseptics, known as the Health Care Continuum Model (HCCM), which was created out of concern from the TFM proposing unreasonable product classifications and efficacy requirements. Discussions between the FDA and the antimicrobial industry continue concerning the types of antiseptic products to be tested for an intended application.
Antimicrobial Label Terminology
Label is defined as any written, printed or graphic material on or attached to the pesticide or device or any of its containers or wrappers. Labeling refers to any written, printed or graphic material which accompanies the pesticide or device at any time or to which reference is made on the label or in literature accompanying the product.
EPA and FDA have also defined printed and electronic media ads including Internet and e-commerce as well as package inserts, displays at point of sale, marketing and sales brochures, MSDSs, technical bulletins, training materials, and testimonials at trade shows as subject to regulations under product labeling. FDA has even been known to consider off-label promotion by drug company representatives as enforceable under the Food and Drugs Act.
One of the most important words in the Federal Insecticide, Fungicide and Rodenticide Act is intended. Products are pesticides if they are intended for preventing, destroying, repelling, or mitigating any pest. Intent is determined by claims on the label and/or composition/mode of action of the product as distributed or sold. If a label in any way implies that the intent of the product is to prevent, mitigate, or destroy any type of pest, the product falls under this regulatory jurisdiction.
The definition of intent is a gray area; therefore, drug/pesticide companies must regulate their labeling carefully. Some action words that constitute a pesticide claim are prevents, inhibits, disinfects, resists, reduces, controls, eliminates, kills, fights, removes, sanitizes, traps, destroys, and repels.4 Examples of key words that could constitute a drug claim regulated by FDA are treatment, therapeutic, relieves, assists, penetrates, and medicated.
Products that do not make pestidical claims but have ingredients that are well-known pesticides with no other non-pesticidal function are considered a pesticide under FIFRA. Even if pesticidal claims are not made for the product and the active ingredient is not currently recognized as a pesticide active ingredient, the mode of action of the product may be pesticidal in nature. In such cases, the product would be considered a pesticide if the product has no other non-pesticide function.
By understanding the components of an antimicrobial product label, the infection control practitioner can make the proper product decisions for use in their facility.
For a complete list of references visit www.infectioncontroltoday.com
Kirsten Buck is a principle technical affairs specialist at Ecolab in Mendota Heights, Minn. Marcia Ellis is a registration specialist at Ecolab in St. Paul, Minn.
When Used as Directed...
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