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March 1, 2001

Antimicrobial Product Labels and Regulations

Antimicrobial Product Labels and Regulations

By Marcia Ellis and Kirsten Buck

Antimicrobial products, whether they be hard surface disinfectants or skincare products, are essential in infection control. It is important for theinfection control practitioner to understand the label information andregulations governing that information to choose appropriate products to use intheir facility.

The Environmental Protection Agency (EPA) is the government agency thatregulates pesticides, which not only includes insecticides, but also germicides.The EPA is responsible for the safety and effectiveness of disinfectants used onenvironmental surfaces.

The Food and Drug Administration (FDA) is the government agency responsiblefor 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 andperacids, although they are disinfectants, are regulated by the FDA because theyare considered accessories to medical devices. In order to make the dualjurisdiction work, the EPA and FDA have developed a Memorandum of Understanding(MOU) to define each agency's role and the interaction between the agencies.

Disinfectant Label

A lot of work goes into an EPA-approved disinfectant label. Depending on theproduct and type of active ingredient, it may take from six months to a yearbefore a label is approved. The EPA registration number on the label consists ofat 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 setidentifies the specific product formula (e.g., 67). The third set, ifpresent, identifies the supplemental registrant of the formula, meaning that theproduct is being sold by a company other than the registrant (e.g.,8910).

The end-use product registration package for a disinfectant must containthree types of data: chemical characterization, antimicrobial efficacy, andtoxicity. The label information is derived directly from this data1

The chemical characterization data assures product stability, packagingcompatibility, and supports the active ingredient statement in area one of thefront 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. Thissection 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). Thedilution directions, contact time, temperature, organic challenge, and hardwater challenge are documented as part of the efficacy study. To obtain a claimas a hospital disinfectant, the product must be tested against Staphylococcusaureus, Salmonella choleraesuis, and Pseudomonas aeruginosa.Additional bacteria, as well as fungi and viruses, can be added to the labelwith supporting data under the same conditions as the hospital disinfectanttest.

Area four of the label indicates storage and disposal instructions, includingthe disposal of residual antimicrobial product and the disposal of the emptycontainer.

Antiseptic Label

The APIC Guideline for Handwashing and Hand Antisepsis in Health CareSettings is an excellent tool for selecting an appropriate antiseptic product toachieve the best infection prevention possible.2 Product literature,such as a research bulletin, is also very helpful for indications ofproduct-specific antimicrobial efficacy. Research on the final formulation of ahandcare product is especially helpful, as the activity of the antimicrobial issensitive to change in formulation. Detergents, emollients, and otheringredients can reduce or enhance the antimicrobial efficacy of the activeingredient.

Antiseptic skin care products should include the active ingredient andpercentage in the formula. In the US, the product should have a national drugcode number (NDC number), which consists of ten digits with three sections. Thefirst section represents the manufacturer, the second identifies the products,and the third indicates the package size. DIN numbers, or drug identificationnumbers, are assigned by Health Canada for any antimicrobial, includingdisinfectants. These numbers are assigned sequentially.

In 1978, the FDA published the first Tentative Final Monograph (TFM) forOver-the-Counter Drugs Generally Recognized as Safe, Effective, and notMisbranded.3 The latest revision of this document was published in1994, titled "Topical Antimicrobial Drug Products for Over-the-CounterHuman Use; Tentative Final Monograph for Health-Care Antiseptic DrugProducts." This document serves as the proposed rule by which the FDA willevaluate the safety and effectiveness of all antiseptics.

In this proposed regulation, each antimicrobial active ingredient is assigneda classification ranking based on the availability and review of manufacturerssafety and efficacy data. Each antiseptic application type (healthcare personnelhandwash, antiseptic handwash, patient preoperative preparation, surgical handscrub) required defined antimicrobial efficacy data. This data typicallyincludes 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 bymanufacturers. In 1994, a coalition was formed through a cooperative effort ofthe Soap and Detergent Association (SDA) and the Cosmetic, Toiletry andFragrance Association (CTFA). This coalition has proposed a new model for theclassification of topical antiseptics, known as the Health Care Continuum Model(HCCM), which was created out of concern from the TFM proposing unreasonableproduct classifications and efficacy requirements. Discussions between the FDAand the antimicrobial industry continue concerning the types of antisepticproducts to be tested for an intended application.

Antimicrobial Label Terminology

Label is defined as any written, printed or graphic material on orattached to the pesticide or device or any of its containers or wrappers. Labelingrefers to any written, printed or graphic material which accompanies thepesticide or device at any time or to which reference is made on the label or inliterature accompanying the product.

EPA and FDA have also defined printed and electronic media ads includingInternet 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 productlabeling. FDA has even been known to consider off-label promotion by drugcompany representatives as enforceable under the Food and Drugs Act.

One of the most important words in the Federal Insecticide, Fungicide andRodenticide Act is intended. Products are pesticides if they are intendedfor preventing, destroying, repelling, or mitigating any pest. Intent isdetermined by claims on the label and/or composition/mode of action of theproduct as distributed or sold. If a label in any way implies that the intent ofthe product is to prevent, mitigate, or destroy any type of pest, the productfalls under this regulatory jurisdiction.

The definition of intent is a gray area; therefore, drug/pesticide companiesmust regulate their labeling carefully. Some action words that constitute apesticide claim are prevents, inhibits, disinfects, resists, reduces, controls,eliminates, kills, fights, removes, sanitizes, traps, destroys, and repels.4Examples of key words that could constitute a drug claim regulated by FDA aretreatment, therapeutic, relieves, assists, penetrates, and medicated.

Products that do not make pestidical claims but have ingredients that arewell-known pesticides with no other non-pesticidal function are considered apesticide under FIFRA. Even if pesticidal claims are not made for the productand the active ingredient is not currently recognized as a pesticide activeingredient, the mode of action of the product may be pesticidal in nature. Insuch cases, the product would be considered a pesticide if the product has noother non-pesticide function.

By understanding the components of an antimicrobial product label, theinfection control practitioner can make the proper product decisions for use intheir facility.

For a complete list of references visit www.infectioncontroltoday.com

Kirsten Buck is a principle technical affairs specialist at Ecolab inMendota Heights, Minn. Marcia Ellis is a registration specialist at Ecolab inSt. Paul, Minn.

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Product labels prescribe safe, effective product use

By Janet B. Kreizman

Commercial cleaning products play an important role in protecting public health. Their superior antimicrobial cleaning capabilities fight against the wide variety of pathogens found in institutional settings. This performance requires the use of powerful sanitizing agents. Careful reading of lables helps ensure that the products work effectively and are used according to manufacturer instructions. Product labeling, which is regulated and monitored by various federal and state agencies, provides the user with pertinent information about the product, such as content, instructions for proper use, safety information and what to do if an accident occurs while using the product. Product labels are the user's guide to prudent, responsible product use.

All labels must include:

The language used on product labels prescribes proper and responsible product use and encourages respect for consumer products. Additional wording, such as flammable and corrosive again are provided to help consumers safely manage use and storage of chemical products. Improper use, intentional misuse, or unintentional exposure to chemical products potentially can pose health risks; however, products used and handled according to label directions are not hazardous to human health or the environment.

Occupational Safety and Health Administration (OSHA) guidelines require employers to provide initial and ongoing employee training on these types of chemical products used in institutional settings. Employers also are required to have a material safety data sheet (MSDS) for all chemicals and chemical mixtures received from the product manufacturer. The MSDS is developed by the product manufacturer and provides detailed information about potentially hazardous chemicals, including physical and health hazards associated with the chemical, control measures, and emergency and first aid procedures.

Labels place the most pertinent of this information on the product for easy reference. They are an important component of proper product management in the workplace.

Janet B. Kreizman is executive director of the Alliance for Consumer Education (ACE), a non-profit public charity founded to promote the safety, health and well being of children, families and communities--wherever household and institutional products are used. Ms. Kreizman has also worked on behalf of a number of private and public sector clients on issues such as transportation, energy, health, and education.



For a complete list of references click here