Global Regulatory Updates


USEPA Position on Products Treated with Antimicrobials

Posted by on 2:05 am in Electronic Journal, Global Regulatory Updates | 0 comments

Consumer Products Treated with Antimicrobials

US Environmental Protection Agency Position

Background

The presence of microorganisms (bacteria, fungi, and viruses) in or on various items has become of increased concern to consumers. In response to these concerns, many products (e.g., cutting boards, kitchen sponges, towels, cat litter, toothbrushes, and juvenile toys) are being treated with antimicrobial pesticides. Antimicrobial pesticides are substances or mixtures of substances used to destroy or limit the growth of microorganisms, whether bacteria, viruses, or fungi -- many of which are harmful-on inanimate objects and surfaces.

The term “treated articles” typically refers to articles or products (towels) that are treated with an antimicrobial to protect the articles or products themselves. The antimicrobials are usually added to the products (e.g., socks) during manufacture; however, they may be added after manufacture but before use of the article (e.g., incorporation of an antimicrobial in paint).

These treated products often make implied or explicit public health antimicrobial or antibacterial claims to protect the public against harmful microorganisms.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the registration of any substance intended to prevent, destroy, repel, or mitigate pests. However, the Code of Federal Regulations prescribes the conditions under which an exemption from registration is allowed for treated articles or substances. It allows an exemption for:

An article or a substance treated with or containing an antimicrobial to protect the article or substance itself (for example, a towel treated with an antimicrobial to protect the towel from growing microorganisms that cause odor, or wood products treated to protect the wood against mold), provided that the antimicrobial is registered for use on the treated article.

EPA grants the treated articles exemption for a non-public-health use of an antimicrobial that is intended to protect only the treated article or substance itself. Products that qualify for this exemption must display appropriate clarifying statements. For example, claims for treated articles or substances are limited to statements like:

This towel features antibacterial protection against odor-causing bacteria.

Treated kitchen accessories or other food contact articles such as a cutting board, high chair or kitchen towels that may come in contact with food should carry an appropriately qualifying statement, such as:

This product does not protect users or others against food-born bacteria. Always clean and wash this product thoroughly before and after each use.

In addition, it should be noted that:

The treated articles exemption is available only for the protection of the product and not for public health uses.

The antimicrobial claim and qualifying statement on the product packaging (type, size color) must be given no greater prominence than other described product features

Public Health Claims

Because consumers have long associated the following widely used claims and references to

microorganisms harmful to humans with products providing public health protection, EPA considers an article or substance to make a public health claim if any of the following claims are made either explicitly or implicitly:

1. A claim for control of specific microorganisms or classes of microorganisms that are directly

or indirectly infectious or pathogenic to man (or both man and animals). Examples of specific

microorganisms include Mycobacterium tuberculosis, Pseudomonas aeruginosa, E. coli, HIV, Streptococcus and Staphylococcus aureus.

2. A claim for the product as a sterilant, disinfectant, virucide or sanitizer, regardless of the site of use of the product, and regardless of whether specific microorganisms are identified.

3. A claim of “antibacterial,” “bactericidal,” or “germicidal” activity or references in any context to activity against germs or human pathogenic organisms implying public health related protection is made.

4. A claim for the product as a fungicide against fungi infections or fungi pathogenic to man, or the product does not clearly indicate it is intended for use against non-public health fungi.

5. A claim to control the spread of allergens through the inhibition or removal of microorganisms such as mold or mildew.

6. A non-specific claim that the product will beneficially impact or affect public health by

pesticidal means at the site of use or in the environment in which applied.

7. An unqualified claim of “antimicrobial” activity. Refer to Unit IV.C.

B. Non-Public Health Claims

EPA considers a product to make a non-public health claim if any of the following applies:

1. A claim to inhibit the growth of mildew on the surface of a dried paint film or paint coating.

2. A claim to inhibit microorganisms which may cause spoilage or fouling of the treated article or substance.

3. A claim to inhibit offensive odors in the treated article or substance.

4. EPA considers terms such as “antimicrobial,” “fungistatic,” “mildew-resistant,” and “preservative,” as being acceptable for exempted treated articles or substances provided that they are properly, and very clearly, qualified as to their intended non-public health use. Refer to Unit IV.C. Use of these terms in product names or elsewhere in the labeling in bolder text than accompanying information may render such qualifications inadequate.

III. PAST EPA LABELING CLAIMS INTERPRETATIONS

A. Odor and Mildew-Resistant Properties May Be Claimed

Over the past twenty-five years the Agency has issued several interpretations concerning the exemption from FIFRA regulations of certain types of antimicrobial treated article claims associated with mildew-resistant paint, films and coatings. In the same period, EPA has also issued other interpretations concerning certain types of odor-resistant antimicrobial treated article claims. During this period there has been widespread dissemination and adoption by the antimicrobial product community of these EPA interpretations regarding mildew-resistant and odor-resistant claims under the “treated articles exemption.” Furthermore, the Agency continues to treat these general types of claims as covered by the term “to protect the treated article or substance itself” because mitigation of these non-public health related organisms can contribute to the protection of the appearance and maintenance of the intended useful life of the treated article or substance. Because during this period, there has also been widespread misinterpretation of EPA’s guidance, the Agency has developed a representative set of statements designed to clarify its position in this area. Consequently, if they otherwise qualify for the exemption, properly labeled treated articles and substances bearing claims such as those described under Unit IV.B. continue to be eligible for the treated articles exemption.

B. Product Names May Not Contain Public Health Claims

The Agency regards trademarked product names of treated articles or substances [or references to trademarked names of registered pesticides] as potential sources of public health claims that could render a product ineligible for the “treated articles exemption” just as could other direct or indirect public health claims on or in a product’s packaging or in its labeling or advertising literature.

The Agency has maintained this position in enforcement actions against antimicrobial-treated articles, such as antimicrobial-treated cutting boards and other items, which bore names suggesting health or other benefits beyond mere preservation of the treated article itself. In determining the eligibility of a treated article or substance for the exemption, the Agency will examine the product name, its context, labeling claims and other related elements on a case-by-case basis

IV. TREATED ARTICLE LABELING CLAIMS

Products treated with antimicrobials with claims such as those described in Section A below are likely to not be acceptable under the “treated articles exemption” because they imply or express protection that extends beyond the treated article or substance itself. Products treated with antimicrobial pesticides registered for such use and which only bear claims for protection of the article or substance itself such as those described in Section B below are likely to be acceptable and eligible for the “treated articles exemption”, assuming all other conditions have been met. Section C below contains examples of appropriate qualifying and prominence statements which have been extracted from multiple enforcement proceedings dealing with claims that can be made for treated articles without obtaining registration.

A. Examples of Labeling Claims That the Agency is Likely to Consider Unacceptable

Under the Exemption

The following examples are not intended to be an all-inclusive listing of unacceptable treated article labeling claims. If persons are not sure whether their antimicrobial pesticides are covered by the provisions of this section, the Agency encourages them to request a written opinion from the Antimicrobials Division.

These examples represent claims or types of claims for a treated article that would lead to a requirement to register the article as a pesticide product.

o Antibacterial

o Bactericidal

o Germicidal

o Kills pathogenic bacteria.

o Effective against E. coli and Staphylococcus.

o Reduces the risk of food-borne illness from bacteria.

o Provides a germ-resistant surface.

o Provides a bacteria-resistant surface.

o Surface kills common gram positive and negative bacteria.

o Surface controls both gram positive and negative bacteria.

o Surface minimizes the growth of both gram positive and negative bacteria.

o Reduces risk of cross-contamination from bacteria.

o Controls allergy causing microorganisms.

o Improves indoor air quality through the reduction of microorganisms.

B. Examples of Labeling Claims the Agency is Likely to Consider Acceptable Under the

Exemption

The following examples are not intended to be an all-inclusive listing of acceptable treated article labeling claims. If persons are not sure whether their antimicrobial pesticides are covered by the provisions of this section, the Agency encourages them to request a written opinion from the Antimicrobials Division.

1. Mold and Mildew Resistant Claims

o This article has been treated with a fungistatic agent to protect the product from fungal growth.

o Mildew Resistant - treated with a fungistatic agent to protect the paint itself from the growth of

mildew.

o Mildew Resistant - This paint contains a preservative which inhibits the growth of mildew on the

surface of this paint film.

o Mildew Resistant - Extends useful life of article by controlling deterioration caused by

mildew.

o Algae Resistant - This article contains

2. Odor Resistant Claims

o This product contains an antimicrobial agent to control odors.

o This product contains an antimicrobial agent to prevent microorganisms from degrading the product.

o Resists Odors - This product has been treated to resist bacterial odors.

o Inhibits the growth of bacterial odors.

o Resists microbial odor development.

o Retards the growth and action of bacterial odors.

o Guards against the growth of odors from microbial causes.

o Guards against degradation from microorganisms.

o Reduces odors from microorganisms.

o Odor-resistant.

o Acts to mitigate the development of odors.

C. Antimicrobial Qualifying and Prominence Considerations

EPA does not believe that claims such as “antimicrobial,” “fungistatic,” “mildew-resistant,” and “preservative” or related terms are consistent with the intent of 40 CFR 152.25(a) if they are: (1) part of the name of the product; or (2) not properly qualified as to their intended non-public health use. Examples of permissible statements would include, but not be limited to: “Antimicrobial properties built in to protect the product” and “Provides mildew-resistant dried paint coating.” All references to the antimicrobial properties and the required qualifying statements should be located together, should be printed in type of the same size, style, and color, and should be given equal prominence. Moreover, such references should not be given any greater prominence than any other described product feature. In addition, treated articles or substances intended for microbial odor control or article preservation in areas where food-borne or disease-causing organisms may be present have the potential to create the impression that the article provides protection against food-borne and disease-causing bacteria. This potential should be addressed through very careful narrowing and qualification of the non-public health claims. A complete assurance that there is no misleading impression could be achieved through use of language like: “This product does not protect users or others against food-borne (or disease-causing) bacteria. Always clean this product thoroughly after each use.” or “This product does not protect users or others against bacteria, viruses, germs or other disease organisms. Always clean this product thoroughly after each use.”

 

Articles or products (towels) that claim to be effective in controlling microorganisms such as E.coli, S.aureus, Salmonella sp. Streptococcus sp. Or Viruses must be registered as a pesticide. These articles or products make a public health claim that goes beyond the aesthetic preservation of the treated article itself. EPA requires the submission of chemical data in support of the public health labeling claims and patterns of use of the product. Any antimicrobial-treated product that is not registered by EPA must not make public health claims, such as "fights germs, provides antibacterial protection, or controls fungus."

Enforcement

FIFRA does not allow companies to make public health claims for any antimicrobial treated product distributed or sold unless the product has been approved and registered by EPA. EPA is concerned about these claims because, in addition to being unlawful, they are also potentially harmful to the public (e.g., if people believe that a product has a self-sanitizing quality, they may become lax in their hygiene practices). Practicing standard hygiene practices has been proven to prevent the transmission of harmful microorganisms and, therefore, reduce the possibility of public health risk.

In response to the marketing of unregistered pesticide-treated products with illegal, unsubstantiated public health claims, EPA has acted quickly and decisively to prohibit sales of such products. EPA has stated that it will continue to be the Agency's policy to take action against companies that make such illegal claims.

Why USEPA’s Approach Makes Sense

Posted by on 5:28 pm in Global Regulatory Updates | 0 comments

Why the USEPA’s Approach to Antimicrobial Claims Makes Sense

us-epa-logo The USEPA is often seen as being at odds with American business interests. We hear the construction industry voice its concerns about how the EPA focuses on the protection of some isolated endangered species while curtailing developments that create jobs. We also hear from the industrial giants about how restrictive the USEPA regulations on automobiles, factories and electric generators can be. Some of these restrictions are obviously overdue and bring about proper protections, others appear to be hard to justify in any light. The USEPA policies regarding antimicrobial claims that can be made for products sold under the treated articles exemption have been around for well over a decade and have had a rather logical progression that has been relatively easy to figure out and to follow. Anyone that doesn’t know what I am talking about should take the IAC 103; “Treated Articles Claims Course” and learn more about this important subject.

Aside from explaining the law that established and governs the treated article exemption, IAC 103 provides examples of appropriate and inappropriate claims that are made for treated articles. While learning what you can and can’t say on product packaging is an important part of the curriculum, you’ll also learn what requirements need to be met before you consider making any claims. With so many treated articles being produced overseas, IAC 103 will walk you through what antimicrobial technologies can be used and how you can assure that the specified antimicrobial is actually being used on your treated article.

Sign up for IAC103 by going to the IAC Education page. Look for IAC 103 under the Webinar tab. IAC103 is provided free of charge for IAC members. Those not IAC members.