- WEB EXCLUSIVE
- PE COFFEEHAUS
The EPA proposed on Dec. 31, 2012, a new rule intended to address a long-standing enforcement issue. 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. The 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 federal and state inspectors what ingredients are permitted in minimum risk pesticide products. The agency 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.
The EPA is proposing to replace the text in 40 C.F.R. 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.): The 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.
The EPA emphasizes that it is only providing additional clarity concerning the ingredients that are currently used in exempted products. The agency is not proposing to add or remove ingredients from the list.
For approximately 20 of the active ingredients in the proposed table, the agency 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.
The 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 what inert ingredients may be used in these products, the EPA is proposing to codify in the C.F.R. a reference to sections detailing what 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 the EPA, provide the clarity needed for understanding what commonly consumed food commodities, animal feed items, and edible fats and oils can be used in exempted products. Additionally, the 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
The EPA is specifically seeking comment on several issues, including:
- he 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.