By Lisa M. Campbell and Lisa R. Burchi
The final rule revising the U.S. Environmental Protection Agency (EPA) regulations governing the minimum risk pesticide exemption from pesticide registration requirements was published in the Federal Register on December 28, 2015. The revisions include codifying the inert ingredients list and adding specific chemical identifiers, where available, for all active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption. Labeling requirements for minimum risk pesticides are also revised to require manufacturers to list ingredients on product labels with a designated label display name and to provide the producer’s contact information on the products’ labels. EPA states that the revisions are intended to “clarify the terms of the original exemption and to provide additional clarity and transparency concerning the ingredients that are currently used in exempted products.” Information regarding the proposed rule that was issued on December 31, 2012, is available in our memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.
The final rule will become effective on February 26, 2016. The compliance date for the new label requirements is February 26, 2019.
Under the revised regulations, the minimum risk exemption requirements are as follows:
- Condition 1: The product's active ingredients must be only those that are listed in 40 C.F.R. Section 152.25(f)(1). Previously, the regulations included only the names of the active ingredients. Under the newly revised reguations, the new Table 1 includes the “Label Display Name,” the “Chemical Name,” any “Specifications,” and the Chemical Abstracts Services Registry Number (CAS No.).
- In response to comments, EPA restored two active ingredients inadvertently omitted from the proposed rule (sodium chloride and ground sesame plant) and clarified how “mint and mint oils” are listed. EPA also has changed the name of one active ingredient from cedar oil to cedarwood oil and clarified its chemical names and CAS Nos.
- EPA removed United States Pharmacopeia (USP) specifications for 19 active ingredients because such specifications would have removed technical grade active ingredients that are currently eligible but do not meet USP specifications, and EPA states that it did not intend with this rule to add or remove substances from the ingredients list. The USP specification for castor oil remains since that was part of the original active ingredient list.
- Condition 2: Prior to these revisions, EPA’s regulations stated that a product's inert ingredients may be only those that have been classified by EPA as: (1) List 4A “Inert Ingredients of Minimal Concern”; (2) commonly consumed food commodities, animal feed items, and edible fats and oils as described in 40 C.F.R. Sections 180.950(a), (b), and (c); and (3) certain chemical substances listed under 40 C.F.R. Section 180.950(e). The final rule codifies, at 40 C.F.R. Section 152.25(f)(2)(iv), a list of inert ingredients permitted in minimum risk pesticide products. The codified list at Table 2 includes the “Label Display Name,” the “Chemical Name,” and the Chemical Abstract Services Registry Number (CAS No.).
- In response to comments, EPA removed from the “Label Display Name” certain bracketed language intended to provide clarifying language, for example, “safety limitations on certain inert ingredients such as vinegar (maximum 8% acetic acid in solutions) to chemical formulas for inert ingredients such as calcite (Ca(CO3)).” This bracketed language remains in the Chemical Name column to assist manufacturers in correctly identifying inert ingredients eligible for the exemption.
- As it did with respect to active ingredients, EPA states that this rule is not intended to add or remove any inert ingredients. EPA states that it is considering developing guidance to describe the petition process and types of information EPA would need to add or delete an inert ingredient from this list.
- Condition 3: Previously, EPA required that all of the ingredients (both active and inert) be listed on the label, with active ingredient(s) listed by name and percentage by weight and each inert ingredient listed by name only. Under the provisions of the newly promulgated rule, the label must include the following: (1) the “Label Display Name” for each active ingredient with its percentage by weight; (2) the “Label Display Name” for each inert ingredient; (3) “prominent” display of the name of the producer or the company for whom the product was produced; and (4) “prominent” display of contact information (i.e., street address including zip code and telephone number) for the producer/company listed.
- Condition 4: The label cannot include any false or misleading statements. The final rule does not propose any explicit changes to this condition, but some new changes may affect the requirements necessary to meet this condition. For example, under the newly promulgated revisions, while all active and inert ingredients may be used in non-food use products, “food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter.” Regarding requirement, EPA states:
- EPA is not attempting to enforce adherence to the labels of minimum risk pesticides, which as noted cannot be done for pesticides subject to 40 CFR 152.25(f). Rather, the Agency is assisting minimum risk pesticide producers in ensuring that the use directions on the product do not cause the label to be false or misleading. An exemption from FIFRA requirements under section 25(b) of the statute, including the minimum risk exemption at 40 CFR 152.25(f), cannot exempt pesticides from the requirements of a tolerance or tolerance exemption under FFDCA. Under FFDCA, any pesticide chemical residue to be used in or on foods in commerce in the United States must have either an established tolerance or tolerance exemption. When a minimum risk product explicitly states on its label that it can be used in or on food or food-use sites in commerce, but one or more of the ingredients does not have an established tolerance or tolerance exemption, the label is indicating that the product may be used in a way that would violate Federal law. Such a label is therefore false or misleading.
- Condition 5: The product must not bear claims either to control or mitigate organisms that pose a threat to human health, or to control insects or rodents carrying specific diseases. The final rule does not change this condition.
EPA states that it intends the newly promulgated revisions to assist manufacturers, the public, and federal, state, and tribal inspectors in determining whether a chemical substance can be used in a minimum risk product (i.e., is eligible for the exemption) as well as to provide improved clarity and transparency for consumers who want more information about the ingredients used in a product. EPA also hopes that requiring company contact information on labels will provide further transparency and accountability should an adverse event occur during the use of a minimum risk pesticide product.
EPA has determined that the total cost for industry to comply with the labeling requirements of this rulemaking is approximately $800,000, under a three-year implementation period. The three-year implementation period was extended from the two-year proposed implementation plan in response to comments that “[s]ince most companies update their labels every three years…a rule implementation period of three years will allow most companies to meet the labeling requirements of the rule as part of their normal labeling practices and will therefore keep industry costs to a minimum.”
EPA’s recently updated minimum risk pesticides webpage includes guidance on pesticide tolerances for minimum risk ingredients and provides alternative formats of the active and inert ingredient lists that may be more suitable for some users. EPA states that it intends to include additional guidance, as needed, such as labeling guidance for minimum risk pesticides and how to request additional ingredients to be added or removed from the minimum risk exemption shortly after the final rule becomes effective.