Comment submitted by C. McCormick

The following comments are respectfully submitted on the following FR request for comments: Prions; Proposed Amendment To Clarify Product Performance Data for Products With Prion- Related Claims and Availability of Draft Test Guidelines. Pages 71294-71299 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 Congress and would require a modification of the Act rather than a slight-of- hand approach by modifying the intent of the Act through a regulatory “declaration”. Clearly, EPA has opted to ignore prior court decisions regarding definitions and clarity of text. In FIFRA, there is no ambiguous use of the terms used to define the scope of coverage of the term Pest. In Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1984), the Court clearly established that where there is statutory clarity in the terms used, there is little opportunity to use regulatory or other non-statutory methods to modify the intent or requirements of a statute. Clearly, EPA is not considering whether it should, but rather can it use a “declaration” to modify a statute. The answer is no. This is not a place to try to establish a precedent. The commenter appreciates EPA’s desire to a avoid modification of the Statute through Congressional action in the current political climate. However, designating a new life form (without the endorsement of the National Science Foundation, Science Advisory Board or other scientific experts), using its regulatory authority to modify the intent of Congress, and bypassing established law making processes raises basic due process and Constitutional concerns. Curt McCormick (720) 320-1945 Curt@POTW.com www.POTW.com