Pesticide Labeling Questions & Answers - Antimicrobial Claims
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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).
These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
- Advertising Claims
- Antimicrobial Claims
- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- Can an antimicrobial product to be used as a hard surface disinfectant have a contact time of greater than 10 minutes? There currently doesn’t appear to be any guidance documents prohibiting contact times of greater than 10 minutes for hard disinfectants. LC11-0481; 12/08/11
While the Agency reviews proposed contact times for disinfectant products on a product-by-product basis, in general, the Agency does not accept a hard surface disinfectant contact time of greater than 10 minutes unless the material to be disinfected is to be immersed in the disinfectant product solution as part of the disinfection process. Disinfectants that are applied to surfaces that are not immersed in the disinfectant product solution will dry out and therefore contact with the disinfectant product solution will generally not last longer than 10 minutes. The Agency recommends the use of the AOAC International Use-Dilution Methods or the AOAC International Hard Surface Carrier Test Methods (distilled water only) to develop efficacy data to support a disinfectant claim. These methods specify a contact time of 10 minutes or less. In addition, on January 27, 2010 the Agency made available to the public for comment its draft proposed 810.2000 Series Product Performance Guidelines which included draft proposed guidelines for disinfectant treatment of hard surfaces. That document can be viewed at http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0681-0004. The proposed disinfectant guidelines for use of antimicrobials on hard surfaces (810.2200) would, once they are final, specify that disinfection of hard surfaces be achieved within a disinfectant product contact time of 10 minutes or less.
- Is it allowable to have a statement on an unregistered cleaning product that makes a claim saying "Compare to the Cleaning Performance of ..." a specific EPA registered antimicrobial pesticide product? LC11-0441; 11.30.11
EPA does not have jurisdiction over cleaning products that make no pesticidal claims. However, a label that compares properties of a cleaning product to those of a registered pesticide product appears to make a pesticidal claim, which would likely result in the need to register the cleaning product bearing such claim.
What are the standard levels of Quaternary Ammonium for sanitation? 200 ppm is accepted as the minimum, is there a maximum level that is acceptable or a range, say 200 - 400 ppm? LC11-444; 10/6/11
There are no “standard levels” of a quaternary ammonium that can be used for sanitization. The dosage rate for a sanitization claim is determined by efficacy data that are required to be submitted since sanitization is a public health claim. There are limits established in 40 CFR 180.940 (tolerance exemptions for food contact sanitizers) regarding the ppm level of a solution containing a quaternary ammonium that can be used on a food contact surface. For some quaternary ammonium compounds the maximum level is 200 ppm while for other quaternary ammonium compounds the solution can contain up to 400 ppm. The rate specified on the product label determines the ppm level that can be used in a sanitizing solution whether it is used on non-food or food-contact surfaces.
- Sodium Hypochlorite is commonly used in drinking water as a disinfectant. Can you tell me what the current sodium hypochlorite levels that are allowed for drinking water use and who has a label approved for such use? LC11-405; 5/19/11
Residues of sodium hypochlorite in water are measured as available chlorine. In 1998, the Office of Water (OW) working with the Office of Pesticide Programs (OPP) established a maximum residual disinfectant level (MRDL) of 4.0 mg/L (ppm) for chlorine (40 CFR 141.54) that is allowable in community water systems (CWSs) and nontransient noncommunity water systems (NTNCWs) from either a primary or secondary disinfectant treatment. The FR Notice for the final rule can be found at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1998_register&docid=98-32887-filed.pdf (88 pp, 1,011K, About PDF). In general, the Agency does not identify and/or recommend specific pesticide products. Therefore, we suggest that you contact your local water utility to determine what disinfectant products they may be using.
- When is the "General Precautions" statement required on an antimicrobial label? Is the statement required when it is marketed for a hospital or medical facility? If it does not have a hospital or medical claim or the label is for residential do they need the "General Precautions" paragraph? LC11-403; 5/19/11
In general, there are no differences in the precautionary statements required for a hospital product versus a residential product. Precautionary statements may vary among specific products due to the hazards that may be posed by the particular product in question. The major differences between product labels for hospital products versus residential products are differences in the use directions including the use sites and pests. A “General Precautions” statement is not a required label statement and thus does not have to be used on either a hospital or a residential product. Many companies choose to use that format to organize the precautionary information provided to the user. The precautionary statements required on a label are specified in Subparts D and E of 40 CFR Part 156. Further, EPA may require product specific precautionary label statements on a case-by-case basis through the registration process.
Several customers have requested confirmation of what is allowed concerning claims for antimicrobial products. The question has arisen due to the fact that the Agency has allowed claims of effectiveness against H1N1 when the product has a claim against any Influenza A strain. For example, if a product is registered as effective against a single Salmonella species can it be claimed that the product is effective against Salmonella in general? LC10-0371; 08/13/10
In general, the Agency requires registrants to submit efficacy data to support all public-health-related label claims. If a registrant wants to list a specific public-health microorganism on their product label, they would need to generate and submit efficacy data showing the product is effective against that specific microorganism. In the case of H1N1, the Agency believed a different approach was needed due to the emerging threat posed by the spread of Pandemic 2009 H1N1 Influenza A Virus. Thus, the Agency used an approach based on the determination that data submitted to support a claim for control of any Influenza A virus was sufficient to support a label claim against Pandemic 2009 H1N1 Influenza A virus. This determination was in part based on the fact that efficacy data that support use against Influenza A also support use against different strains within the same type of virus. See http://www.epa.gov/oppad001/h1n1-guide.html. However, in the case of Salmonella, 1) the pandemic scenario is not present and 2) the genus of Salmonella is a much broader category of organisms than is encompassed by the Influenza A virus type. Species of Salmonella include those that are resistant to antibiotics as well as those associated with food-borne illness or typhoid fever. Efficacy data on a singles species are not adequate to support a general Salmonella claim and therefore data must be submitted to support each Salmonella species listed on the label.
I work for a state regulatory agency that regulates Day and Home care operations. We have a rule that requires our operations to use specific disinfecting solutions, one of them being a "commercial grade product that meets the EPA's standards for "hospital grade" germicide". In reviewing your website, it seems you do not use this term often. The term you use in "disinfectant". Are these two terms inter-changeable? Secondly, do you have a list of EPA- approved hospital grade germicides available? Is there another term our inspectors should be looking for? (LC09-0268; 8.13.09)
EPA does not categorize disinfectants as “commercial grade” or “hospital grade.” In fact, those types of descriptors are generally considered as misleading with respect to the chemical’s composition and effectiveness (156.10(a)(5)(i) and (ii)) because such statements could lead purchasers to believe they are getting a more effective product which is not necessarily the case. On the other hand, an antimicrobial product label may bear instructions for use in the hospital or medical environment if, among other things, the product passes efficacy testing for such use(s). The efficacy testing guidelines for such products are contained in 91-2(d)(3) of Subdivision G of the Pesticide Assessment Guidelines. Specifically, to be registered for use in a hospital or medical setting (such as a nursing home, day care center, doctors office), the product must be approved as a broad spectrum disinfectant and also must be proven through efficacy testing to be effective against the nosocomial bacterial pathogen Pseudomonas aeruginosa. Additional claims may be made if testing against other specified microorganisms demonstrates that the product is efficacious. Information on efficacy testing for such products can be found in the Subdivision G testing guidelines and at http://www.epa.gov/oppad001/dis_tss_docs/dis-01.htm .
We do not keep a list of EPA registered antimicrobial products that have been registered for use in hospitals.
To assess whether products can be used in hospitals, your inspectors should look for disinfectant products with directions for use in hospitals.
An antimicrobial sanitizer label contains directions for use on food-contact surfaces that require a one-minute contact time although the data requirement for such products specifies only a 30-second performance test. The FDA Food Code, which is used by state and local jurisdictions to develop their own food safety rules, allows as little as a 7-second exposure time under certain circumstances. Is it a violation of the EPA label to use the described sanitizer product in a commercial dishwasher with a 10-second final rinse time (the only contact time with the sanitizer is during the 10-second rinse)? LC09-0254; 6.26.09
It is a violation to use a registered pesticide in a manner inconsistent with its labeling, FIFRA § 12(a))(2)(G). Therefore, it would be a violation of the label to use a registered sanitizer product at less than the contact time specified on the product label. The Food Code may provide a minimum exposure time where it applies but it does not supersede a pesticide’s labeling. In your example, the 10-second final rinse time is the only time during which the sanitizer contacts the surfaces it is sanitizing, therefore the sanitizer is being used inconsistently with its labeling which requires a one-minute contact time.
Can a sanitizer spray be considered to be effective against microorganisms other than those specifically listed on the label if the manufacturer has data to back up the claims? (LC08-0234; 2.26.09)
FIFRA section 12(a)(1)(B) makes it unlawful for any person to distribute or sell any registered pesticide “if any claims made for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registration.” Accordingly, to make lawful claims, including providing or referencing data in connection with the product's sale or distribution, that a sanitizer spray is effective against specific pests, a registrant must submit those proposed claims and supporting data to EPA for approval as a part of its registration package and obtain EPA approval of the proposed claims.
FIFRA section 2(ee) does allow a user to apply “a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment.” It must be noted that with respect to antimicrobial pesticides targeted against human pathogens, 40 CFR Part 168.22(b)(5) states that EPA will regard as unlawful the placement or sponsoring of advertisements which recommend or suggest the purchase or use of a registered pesticide for an unregistered use even if the use would be permitted by FIFRA section 2(ee).
An antimicrobial product uses materials from renewable resources. Will EPA permit labeling to make claims regarding renewable, naturally derived, or biodegradable materials? (LC08-0187)
- ____ material made from X% biodegradable _____
- ____ made from X% biodegradable _____
- ____ made from X% biodegradable materials
- Made with biodegradable ______
- Biodegradable ____ material
- This product is biodegradable (with supporting data for the liquid _________)
- ____ made from X% naturally derived ______
- ____ material made from X% naturally derived ______
- ____ material made from X% renewable ______
- ____ made from X% renewable ______
- ____ made from X% renewable materials
Label claims are evaluated on a case-by-case basis when individual product labels are reviewed and registered. Claims regarding renewable, naturally-derived or biodegradable materials have historically been found to be not acceptable. While these terms may be factually correct in describing some of the attributes of a product, these terms can be misinterpreted as claims that relate to the safety of the product and therefore may be misleading. The terms “naturally” and “renewable” suggest that a particular product contains certain ingredients that are safer than other products that contain other ingredients. EPA does not approve claims that suggest a pesticide is safe, and does not approve claims that could be considered misleading comparative claims about the safety of a product versus other products that do not contain these same ingredients. LC08-0187; 7.8.08
In September 2011, EPA initiated a two-year pilot program to allow claims of biodegradability for products meeting certain criteria. The criteria are posted on the Agency's website at: http://www.epa.gov/pesticides/regulating/labels/biodegradability-claims.html.
- Can a pathogen name (or any portion of a pathogen name) be included in the product name of a registered pesticide? (LC08-0128; 11/8/07)
A pathogen name may be included in a product name if its inclusion does not make the product misbranded because the labeling is false or misleading. See FIFRA § 2(q)(1)(A). Although the Agency discourages the use of pathogens in a product name, product names are reviewed on a case-by-case basis. If there is a concern that a name may be misleading (such as presenting a heightened efficacy claim), the Agency may require evidence that it is not misleading before we accept it.
Many antimicrobial products labeling indicate use on "highchairs" and "toys" but are ambiguous as to use directions. Are "highchairs" and "toys" a food-contact surface or are they a non food-contact surface? If "highchairs" and "toys" are a food-contact surface should there be indication in the label? Since "highchairs" and "toys" come in direct contact with infants/small children hands and mouths, there should be specific directions in antimicrobial product labels to reduce the possibility of contact and ingestion of pesticides. Infants/small children exposure to antimicrobial pesticides is not equivalent to adult. Defining "highchairs" and "toys" as a food-contact surface is a minor definition issue which could reduce "potential" pesticide exposure in a potentially vulnerable population (infants/small children). (LC07-0114; 9/24/07)
The use of an antimicrobial on highchairs is considered to be a food use. However, the use of an antimicrobial on toys is treated as a non-food contact use. The Agency has not typically required a separate set of use directions for use of antimicrobials on highchairs or toys because the rate, method of treatment, target pests and other parameters are the same as for treatment of other hard non-porous surfaces that are typically found on antimicrobial labels. The Agency does assess indirect dietary exposure for uses such as counter tops, appliances, tables, utensils, food packaging and other areas where there may be incidental contact such as high chairs. The Agency uses a FDA model www.cfsan.fda.gov/~dms/opa2pmnc.html , Chemistry recommendations, appendix I, II, III, IV, V) that takes into account application rates, residual solution, area of the treated surface which comes into contact with food, pesticide migration fraction and body weight. In this assessment, the Agency determines whether an additional margin of safety for infants and children is needed. The Agency also evaluates the use of antimicrobial pesticides on toys taking into account the mouthing contact (i.e., incidental oral contact) and the completeness of the data base on toxicity and exposure. If the available data indicate that an additional margin of safety for infants and children is needed (susceptibility and sensitivity issues) then the Agency will apply it.
In regards to claims made by antimicrobial type pesticides, certain statements on labels require EPA registration (such as “kills,” “disinfects” and “sanitizes”). Does EPA consider the term “sanitary” (as in “leaves surfaces sanitary”) to be a pesticidal claim? (LC06-0012)
The Agency considers the appropriateness of the use of the term “sanitary” on product labels on a case-by-case basis. The Agency has generally interpreted the use of this term as implying a state of cleanliness, however, if, among other things, the use of the term implies a claim of antimicrobial properties, the term may be considered a pesticidal claim and if so the product must be registered in order for the product to retain the claim and be able to be lawfully sold or distributed in the U.S. Other factors that may imply that a product’s intended use is for antimicrobial effect include whether the product is similar in composition to FIFRA-registered products that make antimicrobial claims and whether the product contains an ingredient at levels for which there is no functional reason other than pesticidal activity.