EPA Announces Proposed Revisions to FIFRA Minimum Risk Exemption
FIFRA:
In a December 31, 2012 Federal Register notice, (77 Fed. Reg. 76,979) EPA announced a new proposed rule that would revise the labeling requirements for minimum risk pesticide products. The proposed rule affects section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) by changing how minimum risk pesticides are identified on product labels as well as the way ingredient lists are organized in the implementing regulations. In addition, producer contact information will be required on product labels.
Under FIFRA’s § 25(b) minimum risk exemption, pesticides with active and inert ingredients which are demonstrably safe do not need to be registered with EPA. These permitted ingredients are listed in 40 CFR 152.25(f), but because of ambiguities across the various ingredient lists, confusion remains as to which ingredients are covered and how they should be labeled, leading to increased regulatory burden and inefficiencies for state regulators. Many chemicals may be known by producers, regulators, and consumers by different names; for example, soybean oil may be described on a product label as “Glycine Soja Oil.”
EPA’s new proposed rule is intended to make clear which active ingredients are permitted in exempted pesticide products, and does not add or remove any ingredients from the list. Instead, EPA will identify permitted active ingredients by re-organizing them in tables including the chemical’s “Label Display Name” (e.g., “Citric Acid”), “Chemical Name” as determined by the Chemical Abstract Services (“CAS”) (e.g., “2-Hydroxypropane-1,2,3-tricarboxylic acid”) and “CAS Registry Number,” a unique identifier which is easy to use for consumers and widely accepted by industry and regulators alike. In addition, the table will include a “Specifications” column which will be empty for most ingredients, but will indicate the United States Pharmacopeia (“USP”) standard for “approximately 20 of the active ingredients.”
Inactive ingredients will also be re-organized into a table similar to the one proposed for active ingredients. This table will codify “List 4A,” the list of chemicals currently maintained on EPA’s website. In addition, EPA proposes to incorporate references to other CFR sections which describe which chemicals may be used as inert ingredients for the purpose of the minimum risk exemption. In the case of pesticides that may come in contact with foods, for which there are no federal tolerance levels or tolerance exemptions, EPA proposes to amend the text of the exemption to direct users to an EPA website for more information on which of the listed chemicals may be used in food-use pesticide products.
Finally, EPA proposes that exempted product labels must use the “label display name” in the product’s ingredient listing. The proposed rule also requires that producers of minimum risk pesticide products must include their company’s contact information (address and telephone number) on the product label. In the case of a product label which includes the name of a company that is not the producer, EPA proposes that the label text should clarify that the product was “packed for,” “distributed by,” or “sold by” the non-producer company.
EPA is requesting comments on various topics related to this proposal, including: the format and information to be included in the new tables; whether reference to an online resource with more information on food-use pesticide tolerance requirements would provide clarity for stakeholders; impacts on state and local agencies; and whether products would need to be reformulated as a result of the changes. The comment period for this proposed rule ends on April 1, 2013.
