In a previous FR Notice (Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Proposed Rules. Page 4602), EPA proposed to declare a prion (i.e., proteinaceous infectious particle) a ``pest'' and a new life form under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to administratively modify the Act to expressly include prion within the definition of pest.
Clearly, EPA does not appear to be consulting with Agency attorneys and appears to be ignoring rulemaking procedures. EPA needs to drop any further Federal Register notices or proposals until the issue of whether or not a “Prion” is a new life form and appropriate under the definition of a “Pest” under FIFRA.
EPA is incorrectly using its regulatory authority to modify FIFRA to include regulating a chemical rather than an organism as clearly intended by the plain language in FIFRA. Under Section 2(t) [7 U.S.C. 136] of the Act, the term Pest is clearly defined to mean (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under section 25(c)(1).
This definition is explicit in its intended coverage: these are organisms or otherwise contain nucleic acids and have the capability of reproduction. Congress clearly did not intend for EPA to designate chemicals as a new life form.
Prions neither contain nucleic acids nor reproduce inside an organism. These are merely proteins that cause other existing proteins to change conformation resulting in waste products building up on a cell. Proteins are chemicals. FIFRA does not hint at bring a chemical under the purview of the Act regarding registration of disinfection products. This significant change and resultant impact to the regulated community is more appropriately addressed by C
Comment submitted by C. McCormick
This is comment on Proposed Rule
Clarification of Product Performance Data for Products with Prion-Related Claims; Availability
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