By Lisa R. Burchi and Lisa M. Campbell
On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.
DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.
Scope of Notice 2018-1
DPR is currently reevaluating certain pesticide products containing the following active ingredients:
- Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
- Diazinon; and
- Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).
This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.
Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:
- A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
- Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
- New or modified uses (e.g., new crops, pests, or use sites);
- New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
- Significant formulation changes (unless prompted by the reevaluation);
- Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
- Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.
This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation. As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.
DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”
DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact. It is an initiative that many in industry are monitoring closely.
More information on other California DPR-related issues is available on our blog under key phrase California DPR.
By Lisa M. Campbell and Lisa R. Burchi
On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015. Each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017.
The guidance includes information on the registration requirements, as well as:
More details on the requirements are available in our blog items California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims and California DPR Extends Filing Date to Register Pesticide Impregnated Products.
By Lisa M. Campbell and Lisa R. Burchi
On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017. Specifically, each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017. DPR’s California Notice 2015-13 issued on December 11, 2015, informed pesticide product registrants and stakeholders of DPR’s intention to register products made with pesticide impregnated materials and bearing pesticide claims.
The February 22 notice also states the following in terms of the requirements:
- Each company with products made from pesticide impregnated material and sold under their own company name into or within California is required to register the product(s) as a pesticide;
- The product must bear a federally approved pesticide label; DPR will assign a separate California-only registration number for purposes of tracking sales and use of the products in California;
- Each company will need to obtain at least one registration for each use category of product sold (e.g., the apparel use category includes wearable items such as jackets, shirts, hats, socks, pants, and shorts; the non-apparel use category includes non-wearable items such as bedding, tents, seat covers, chopping blocks, shower curtains, and mouse pads); and
- If items are impregnated with different pesticides or different percentages of the same pesticide, separate registrations will be required.
The requirements set forth in this notice do not apply to products that satisfy the requirements to be a treated article, including the requirement that any claims be related to protection of the article/substance itself. The notice applies instead to those pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material. More information on the December 2015 notice is available in our blog item California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims.
By Lisa R. Burchi and Lisa M. Campbell
On December 11, 2015, the California Department of Pesticide Regulation (DPR) issued California Notice 2015-13 that will require each person/company with products made from pesticide impregnated material that are sold into or within California under their own company name to register their product(s) as a pesticide. Examples of pesticide impregnated materials affected by this Notice include apparel (e.g., jackets, shirts, hats, socks, pants, shorts) and non-apparel (e.g., bedding, tents, seat covers, chopping blocks, shower curtains, mouse pads) that make pesticidal claims.
The requirements will be effective November 1, 2016.
DPR currently registers a number of pesticide impregnated textiles bearing pesticidal claims. DPR notes that while these products have been registered either by the manufacturer of the pesticide impregnated material or by the company impregnating the bolts of fabric or clothing, individual companies selling items made from pesticide impregnated textiles were not required to register the materials. Instead, such companies were required only to obtain a pesticide broker’s license from DPR. Under DPR’s new policy, “obtaining a broker’s license will no longer be sufficient for companies selling products under their own company label” (emphasis in original). DPR states it is making this change to “facilitate tracking the use of these products in California and aid in the understanding of potential impacts on water quality and human health.”
With regard to registration requirements for pesticide impregnated products, DPR states that the number of registrations required will depend on several factors, including whether there are different pesticide active ingredients, different percentages of active ingredients, different types of fabrics, and/or different product uses. DPR states that if the product contains the same type and percentage of active ingredient, one registration can be used to cover various types of pesticide impregnated apparel or non-apparel product use categories, but such determination will be made on a case-by-case basis. As an example of products requiring separate registrations, DPR states: “If, for example, a person/company sells apparel impregnated with 0.52% of the active ingredient permethrin and other apparel impregnated with 0.48% of the active ingredient permethrin, two separate apparel registrations will be required because they contain different percentages of active ingredient. The same holds true for a category of non-apparel products.”
This Notice is a significant change in policy, and will impose potentially complicated and costly registration requirements on companies that sell pesticide impregnated material under their own company name but are not necessary familiar with pesticide registration requirements. The number of new registrations that could be required could be substantial considering the number of factors DPR has specified that could trigger separate registrations.
Importantly, DPR clarifies that this Notice is not intended to change its general policy exempting from registration those products that satisfy the requirements to be a treated article. DPR notes that for treated articles, the pesticide, and any related claims, must be related to protection of the article/substance itself. These products are thus distinguishable from pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material.
By Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) has extended, from February 27, 2015, to Friday, March 13, 2015, the submission of written comments following DPR’s January 14, 2015, Registration Fee Workshop where DPR discussed the potential increase in registration fees for pesticide products pursuant to Food and Agricultural Code (FAC) § 12812(a).
Under the proposal, DPR would increase fees for applications and renewals from $750 to $1,150, decrease fees for certain label amendments supported by scientific data from $100 to $25, and create a new fee of $25 for label amendments not supported by scientific data, including substantive label amendments, non-substantive label amendments, label changes required by the U.S. Environmental Protection Agency or any other federal or state agency, amendments to the formulation of the pesticide product, and notifications.