Regulatory compliance is a basic requirement for any antimicrobial
In Europe no one may sell, distribute, or use an antimicrobial unless it has been authorized by the BPR under Directive 98/8/EC.
Under FIFRA no one may sell, distribute, or use an antimicrobial pesticide unless it is registered by the EPA. Registration includes approval by the EPA of the antimicrobial’s label, which must give detailed instructions for its safe use.
In the United States the Environmental Protection Agency (EPA) regulates pesticides under the statutory authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The registration requirements for antimicrobial pesticides differ somewhat from those of other pesticides. For example, EPA requires special tests to ensure efficacy of public health pesticides when the pests are invisible disease-causing microbes, rather than insects or rodents that may be harboring disease organisms. Similarly, determining human and ecological risks from exposure to antimicrobial pesticides requires different types of measurements and models than those needed for pesticides largely applied to crops and other plants. In view of these and other differences, EPA decided that its regulations governing pesticide registration requirements should also incorporate special antimicrobial sections.
In Europe the Biocidal Product Regulation BPR) regulates pesticides under the statutory authority of Directive 98/8/EC. The BPR aims to harmonize the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment. No product may be placed on the market unless it has been authorized in accordance with the provisions of Directive 98/8/EC. Article 16 of the Directive provides however a derogation allowing the placing on the market of products containing existing substances, whilst they are being evaluated under the review program for existing active substances. Products containing existing active substances can be placed on the market in accordance with the rules and practices of Member States until the inclusion of their active substance(s) in Annex I or IA of the Directive.
USEPA Treated Articles Exemption
This exemption is provided under 40 CFR 152.25(a), which is also known as the “Treated Articles Exemption”. Under the Treated Articles Exemption, articles which are treated with an antimicrobial to protect the article itself are exempt from registration under FIFRA (USEPA Registration), provided 1) that any antimicrobial claims made for the treated article do not go beyond claims for protection of the article and 2) that the antimicrobial used is registered for the specific end use.
Exception to the Exemption
In the late 1990’s the USEPA challenged a number of products which were treated with antimicrobials and which were making claims which the EPA believed were improper. Almost all of the challenged claims either expressly or implicitly asserted “health” benefits for the treated goods. EPA issued draft P.R. Notice 98-X on March 10, 1998. A final version (P.R. Notice 2000-1) was issued February 8, 2000. A modification was issued in March of the same year and in December the implementation date was extended. An organization known as the Antimicrobial Treated Articles Coalition (ATAC) was formed to work with the Antimicrobials Division. Dow Chemical was one of the original members of ATAC and is a member of the International Antimicrobial Council (IAC). Consolidated Pathways is also very active with the IAC and has fifteen years of experience working with product claims related to the treated articles exemption.