One exception is products containing no toxicants that are intended to exclude pests only by providing a physical barrier against pest access are not considered pesticides because EPA has determined they are not intended for a pesticidal purpose. 40 CFR 152.10(c). 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: Chapter 1.
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.
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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. 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.
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.
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 Guidance for Testing and Labeling Claims against Pandemic 2009 H1N1 Influenza A Virus. Search EPA Archive
For the purposes of the Worker Protection Standard (WPS), 40 CFR 170.3 defines "greenhouse" as "any operation engaged in the production of agricultural plants inside any structure or space that is enclosed with nonporous covering and that is of sufficient size to permit worker entry. This term included, but is not limited to, polyhouses, mushroom houses, rhubarb houses, and similar structures." EPA has not defined "greenhouse" in the context of use sites but the WPS definition is instructive. If a cold frame is enclosed with nonporous covering and is large enough to permit worker entry, it would likely be considered a greenhouse.
Banded applications are done at-plant over a closed seed furrow, postplant over the row, or post-emergent often as a side-dress application. They are usually superficially soil incorporated with drag chains or tines.
A registrant could add the suggested language you propose as a second label indicating a distributor company name, if the change were reflected on the master label for the product. See 156.10(c). Generally, all information on labeling needs to be approved by EPA in what is collectively referred to as the "master" label. Products can be sold or distributed with a subset of the master labeling provided no changes would be necessary to precautionary statements, use classifications or packaging. To add an alternate distributor name, a registrant could list the standard company name on the master label and include alternates that would be used as appropriate on products depending on how they are distributed. If added as alternative language on the master label, EPA would not treat this scenario as a supplemental distribution as described in 40 CFR 152.132. FIFRA 2(p)(1) defines "label" as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." Thus any writing appearing on the pesticide is considered part of the label that must be approved by EPA and may not be false or misleading. Adding distributor information to the master label, however, may have no effect on state registration fees, which are governed by state laws.
The label of a distributor product must be identical to the master label of the parent product, except as provided in 40 CFR 152.132(d). A supplemental distributor may not add statements such as that proposed in the question unless the master label of the parent product is amended to include the statement
"(ee) TO USE ANY REGISTERED PESTICIDE IN A MANNER INCONSISTENT WITH ITS LABELING.-The term ''to use any registered pesticide in a manner inconsistent with its labeling'' means to use any registered pesticide in a manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency, (2) applying 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 ad-verse effect on the environment, (3) employing any method of application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by the methods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited by the labeling, (5) any use of a pesticide in conformance with section 5, 18, or 24 of this Act, or (6) any use of a pesticide in a manner that the Administrator determines to be consistent with the purposes of this Act. After March 31, 1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution. "
In most cases, the misuse statement should not be included on the labeling of unregistered products being sold, imported or otherwise distributed in the U.S. because the statement would be false. The violation referred to in the misuse statement is a violation of section 12(a)(2)(G), which only prohibits misuse of registered products. Generally, it is not a violation of FIFRA section 12 to use an unregistered pesticide in a manner inconsistent with its labeling. Exceptions may exist based on an EPA order that imposes restrictions on the use of a particular unregistered product (e.g., a cancellation order that allows further use of the now unregistered pesticide), or as the result of an EPA regulation pursuant to FIFRA section 3(a).
Regulations established under FIFRA state, in part: "A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
* * * "b) The substance contains one or more active ingredients and has no significant commercial value as distributed or sold other than
(1) use for a pesticidal purpose (by itself or in combination with any other substance),
(2) use for manufacture of a pesticide;" 40 CFR part 152.15 (emphasis added)
Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims. If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs.
The language "For Industrial/Institutional/Commercial Use Only" does not prohibit a product's sale to consumers for household use. All products are classified as General Use or Restricted Use as described in 40 CFR 152.160. General Use products may be sold to any person without restriction. Products classified for Restricted Use may only be sold to and used by certified applicators or persons under their direct supervision and are therefore prohibited from sale to the general public. The Agency has in certain cases limited the use of products to certain groups of users without classifying the product for Restricted Use. Three examples where this occurs are use by veterinarians, mosquito control officials and persons licensed or certified by a state to apply termiticide products. In these cases, the users are individuals identifiable either by a state credential or by being employed by certain public agencies. Individuals who are not members of these groups may still purchase these products but they are prohibited from using such products. The Agency believes the language "For Industrial/Institutional/Commercial Use Only" is too vague to clearly identify a discrete set of users and therefore would not be an enforceable means of limiting sale or use. 589ccfa754
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