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    If any of the above-cited requirements are not met or if any of the statements or claims state or imply in any way that the pesticide is protecting more than the treated product itself, the treated product would need to be registered.

    One of the conditions in 40 CFR Another condition in 40 CFR More information on FTC's guidelines. Does the Agency distinguish between repellency claims and resistance claims for purposes of determining whether a product is a pesticide? Unless the mulch fits this exception or is otherwise exempt, it would need to be registered to be sold or distributed in the United States. For more detail on what pesticide products are exempt from registration requirements see Pesticide Registration Manual: The Department of Pesticide Regulation's Legal Office is currently reviewing the label of a pool filter product that contains diatomaceous earth.

    The company is claiming that the product is not a pesticide. However, their packaging states the product "removes dirt, harmful pathogens and microbes down to 2 microns. On the other hand, the reference to "harmful pathogens" seems to be getting into the arena of a public health claim.

    EPA consider this product to be a pesticide requiring registration? In order for the product to qualify as a barrier product under 40 CFR The product is not intended to prevent, destroy, repel, or mitigate a pest, or to defoliate, desiccate or regulate the growth of plants. The product or article does not make a pesticidal claim on the labeling or in connection with sale and distribution.

    The product is intended to exclude pests only by providing a physical barrier against pest access, and contains no toxicants. Based on the criteria listed above, this product does not appear to qualify as a barrier because it makes a pesticidal claim and is intended to mitigate a pest the pathogens.

    Top of Page Can you put on the label of a registered pesticide a statement that is a "new and improved" or "next generation" version of a previously unregistered pesticide?

    Terms or marketing claims such as "improved," "next generation," etc. A review of the complete label is needed to determine the acceptability of such terms.

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    May a label contain advertising for a registrant's other products? For example, may it show pictures of fertilizer and other pesticide products the registrant distributes and say "For More Lawn and Garden Products visit. If either condition is not met, the product is misbranded and cannot be sold or distributed. It should be very clear that those products are separate and distinct from the subject product, ie. It is especially important that reference to other products does not distract users from reading the labeled product's Directions for Use.

    Any requirement that products be used in combination to achieve efficacy for a pesticide product must be part of the Directions for Use and must be evaluated by EPA as part of the granting of a registration.

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    The registrant should understand that any reference to a website makes that website labeling and therefore subject to more searching EPA review than if it were not referenced.

    Future versions of a website referenced on a label will also subject to the same review, though at this time the Agency does not require notification or approval of such changes. Please note that distributor products are not allowed to add claims to the label that have not been approved on the parent product's label.

    Therefore, a distributor may not add advertising for its other products unless such advertising is also on the parent product's label. Top of Page A lawn care operator LCO has advertising in a local newspaper advertising its service, claiming mosquito and other pest elimination from customer yards. At the bottom of the ad, it states "Safe.

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    False and misleading claims make a product misbranded and sale and distribution of such product unlawful. It is important to point out, however, that Section 12 a is limited to unlawful sale or distribution, which is defined in FIFRA 2 gg to exclude "the holding or application of registered pesticides This limits EPA's authority to regulate advertising claims made by certain home lawn care service companies that do not sell or distribute pesticides but merely apply them.

    To the extent EPA lacks regulatory authority over advertising of services, however, the Federal Trade Commission's FTC's broad authority to regulate advertising provides a means to regulate and enforce against excessive or misleading claims made by lawn care operators.

    Therefore, lawn care operators that do not sell or distribute pesticides but make false or misleading claims about their services, may be subject to enforcement by the FTC. Antimicrobial Claims Can an antimicrobial product to be used as a hard surface disinfectant have a contact time of greater than 10 minutes?

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    There currently don't appear to be any guidance documents prohibiting contact times of greater than 10 minutes for hard disinfectants. 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.

    These methods specify a contact time of 10 minutes or less. In addition, on January 27, the Agency made available to the public for comment its draft proposed The proposed disinfectant guidelines for use of antimicrobials on hard surfaces Is it allowable to have a statement on an unregistered cleaning product that makes a claim saying "Compare to the Cleaning Performance of 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? 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 For some quaternary ammonium compounds the maximum level is ppm while for other quaternary ammonium compounds the solution can contain up to 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? 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? 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.

    Many companies choose to use that format to organize the precautionary information provided to the user. 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?

    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. 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 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.

    Search EPA Archive 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. 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.

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    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? 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.

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    The efficacy testing guidelines for such products are contained in 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 officethe 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 Disinfectants for Use on Hard Surfaces. 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 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 second final rinse time the only contact time with the sanitizer is during the second rinse? 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.

    In your example, the 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?

    An antimicrobial product uses materials from renewable resources. Will EPA permit labeling to make claims regarding renewable, naturally derived, or biodegradable materials?

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    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.

    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.

    The criteria are posted on the Agency's website at: Can a pathogen name or any portion of a pathogen name be included in the product name of a registered pesticide? 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 claimthe 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?
    As a result, dump sites, or middens, are some of the best contexts from which to reconstruct the lives of past people.

    Unsurprisingly, a large number of alcohol bottles were found. Throughout this academic year, I have written two previous blogs over some of these bottles liquor on campus and one over a gin bottle as has Jeff Painter. Each of these bottles present a unique history or has an interesting story that may otherwise not be told.

    The brothers came from a long line of distillers in Kentucky, dating back to some of the early settlers in the area Odell AMS was not their first distilling company, but it might be one of their most interesting. The company was started aroundduring Prohibition. As I mentioned in one of my previous posts, Prohibition known as the18th Amendment or the Volstead Act did not ban the consumption of alcohol, but the production, transport, and sale of it.

    If it was technically illegal to distill whiskey during the Prohibition years ofhow were the Wathen brothers even able to start a distillery during the first few years after the 18th Amendment was passed?

    They found a loophole. Department of the Treasury during Prohibition. Maladies that alcohol was supposed to have help with included tuberculosis, high blood pressure, asthma, heart disease, pneumonia, cancer, anemia, and many others Nespor ; Appel While Prohibition had mostly religious underpinnings, many doctors saw the enactment of the Volstead Act and subsequent additions further restricting medicinal alcohol as government overreach and its interference in their medical practices Appel As a result, prescription pads for medicinal alcohol were issued by the U.

    Department of the Treasury and liquor could only be prescribed under certain circumstances and in federally regulated amounts Nespor Individuals who did legally obtain liquor could receive one pint every ten days and were required to glue their prescription slip on to the back of the bottle. However, most bottles from this period with still intact labels do not have the prescription on the back either from people not caring or that many pints were sold illegally Appel Some records indicate that Otho became Vice President of National Distillers but then mostly left the business around the repeal while Richard appears to have continued in the liquor industry.

    Numerous brands of liquor operated under the name of American Medicinal Spirits Co. National Distillers was sold to Beam Suntory inmeaning that AMS has mostly dissolved, although products of its legacy are still consumed today.

    The discovery of this bottle in the Brody Dump tells an interesting story of a company that legally skirted prohibition regulations of alcohol sales. Since the East Lansing dump under the Brody complex closed in the late s, this bottle could only have been produced and consumed within a tight window of time.

    Was this particular brand purchased because it was familiar from the prohibition years? Was the owner previously prescribed whiskey? Unfortunately these are questions we will never know the answer to.

    However, it is through discoveries like these that we can add more pieces to the puzzle of what life was like in this area during the first half of the 20th century and how students may have coped with maladies or thirst… during Prohibition. Appel, Jacob M, Take two shots of whiskey and call me in the morning.

    Medicinal Alcohol and Prohibition. American Medicinal Spirits Company.

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