The U.S. Environmental Protection Agency (EPA) proposed on December 31, 2012, a new rule intended to address a long-standing enforcement issue that has vexed federal and state inspectors for years. 77 Fed. Reg. 76979. The proposed rule would require that active and inert ingredients permitted in products eligible for the exemption from registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) for minimum risk pesticides be described more clearly on product labels. EPA proposed to reorganize the lists of eligible active and inert ingredients by adding specific chemical identifiers to make it clearer to manufacturers, the public, and, most importantly, federal and state inspectors which ingredients are permitted in minimum risk pesticide products. EPA also proposed to modify the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label.
Under FIFRA Section 25(b)(2), EPA may exempt from the requirements of FIFRA any pesticide that is 'of a character unnecessary to be subject to [FIFRA].' Pursuant to this authority, in March 1996, EPA issued 40 C.F.R. Section 152.25(g), which exempted from FIFRA any pesticide product consisting solely of specified ingredients that EPA determined to pose 'minimum risk' to humans and the environment. This provision was later re-designated as 40 C.F.R. Section 152.25(f).
Unlike registered pesticides, the sale and distribution of products exempted under Section 152.25(f) do not require registering the products with EPA, paying registration fees, or reporting of production to EPA. To meet the criteria for the minimum risk exemption, a pesticide must contain only specified active and inert ingredients; list active ingredients on the label by name and percent weight in the formula; list inert ingredients on the label by name; not bear claims either to control or mitigate microorganisms that pose a threat to human health, including disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases; and not include false or misleading labeling statements, as specified in Section 156.10(a)(5)(i) through (viii) (including false or misleading statements about product composition, effectiveness, comparison to other products).
According to EPA, restrictions on which ingredients may be used in minimum risk pesticide products are key aspects of the exemption, since the properties of these specific ingredients are the reason EPA exempted minimum risk pesticide products from FIFRA regulatory requirements. Active ingredients for minimum risk pesticide products are listed in 40 C.F.R. Section 152.25(f)(1). No new active ingredients have been added since 1996. Inert ingredients for minimum risk pesticide products were originally listed in List 4A, referenced at 40 C.F.R. Section 152.25(f)(2). List 4A ingredients were described as minimal risk, or 'substances for which there is no information to indicate that there is a basis for concern.' In 1994, EPA added new chemicals to List 4A by publishing an updated list in the Federal Register.
Since 1994, EPA has updated the list of inert ingredients permitted in minimum risk pesticide products on several occasions. Despite EPA's efforts to respond to stakeholder input urging EPA to clarify which inert ingredients are eligible for use in minimum risk pesticide products, stakeholders, including enforcement officials, have struggled with readily knowing which ingredients are eligible for the exemption. According to EPA, the lack of clarity regarding ingredients has produced significant enforcement difficulties. For example, the way active ingredients are currently listed in the exemption is vague, and inspectors are confronted with the need to determine whether certain product ingredients as they are listed on product labels, such as cedar leaf oil or cedar wood oil, are exempt under the more general terminology used in 40 C.F.R. Section 152.25(f), which lists only 'cedar oil.' EPA has attempted to provide clarity by updating its website to explain minimum risk pesticide products, but feedback from stakeholders indicated this was insufficient to address these challenges.
After considering a variety of options, EPA is proposing to replace the text in Section 152.25(f) specifying the active ingredients and their variations with a table that would show, for each permitted active ingredient, the following elements:
- Label Display Name: This is the common chemical name that would be required to be used on labels of products that contain these ingredients;
- Chemical Name, as determined by the Chemical Abstract Services (CAS);
- Specifications: Though this column would generally be empty, some substances listed in the exemption had specifications associated with them in the text of the exemption as published in 1996; and
- CAS Registry Number (CAS No.): EPA listed the CAS No. for each of the chemical substances listed in Section 152.25(f) where a CAS No. was available. A CAS No. is a unique numerical identifier that provides one of the most readily available and universally accepted means of identifying chemical substances. Identifying chemicals permitted in minimum risk pesticides by CAS No. would, according to EPA, assure manufacturers that they are purchasing and using the chemicals that can be used in minimum risk pesticide products. Only substances identified by the CAS No. listed would be permitted for use as active ingredients in minimum risk pesticide products.
EPA emphasizes that it is only providing additional clarity concerning the ingredients that are currently used in exempted products. EPA is not proposing to add or remove ingredients from the list.
For approximately 20 of the active ingredients in the proposed table, EPA is proposing to include the specification of the United States Pharmacopeia (USP) standard in the Specifications column. USP standards are set for quality, purity, and identity, and usually provide information on chemical formula, chemical weight, CAS Nos., function, definition, packaging, storage, and labeling requirements.
EPA is also proposing to codify the existing list of inert ingredients. The minimum risk exemption in Section 152.25(f)(2) references a list of chemicals permitted to be used as inert ingredients that has been updated and currently is maintained on EPA's website. To clarify which inert ingredients may be used in these products, EPA is proposing to codify in the C.F.R. a reference to sections detailing which chemicals may be used in addition to a reformatted version of the table that currently appears online.
The proposed changes to the section of the exemption addressing inert ingredients would include references to 40 C.F.R. Section 180.950(a), (b), and (c), which describe chemical substances exempt from the requirements of a tolerance and that may also be used as inert ingredients in minimum risk pesticides. The regulatory reference will, according to EPA, provide the clarity needed for understanding which commonly consumed food commodities, animal feed items, and edible fats and oils can be used in exempted products. Additionally, EPA is proposing to add a table that would contain the chemicals currently listed in 40 C.F.R. Section 180.950(e) and those that appeared originally on List 4A.
Request for Comment
EPA is specifically seeking comment on several issues, including:
- The format of the ingredient lists;
- The information in the new format of the ingredient lists;
- The proposed reference to a website that contains a table formatted to include more information on exemptions from the requirement of a tolerance;
- EPA's methodology for estimating the costs associated with the proposed label changes;
- The proposed timeframe of two years from the effective date of the final rule for compliance;
- How the changes will impact state and local agencies;
- Effective methods and venues for communicating these proposed changes to affected entities; and
- EPA especially seeks comment on learning of any product that would need to be reformulated as a result of the proposed changes.
Comments are due April 1, 2013.