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EPA/OCSPP RIN: 2070-AD49 Publication ID: Fall 2010 
Title: Plant Incorporated Protectants (PIPs); Exemption for those Based on Viral Coat Protein Genes 
Abstract: EPA is considering the addition of plant-incorporated protectants based on viral coat protein genes to its plant-incorporated protectants exemptions at 40 CFR 174. Substances which plants produce for protection against pests, and the genetic material necessary to produce them, are pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), if humans intend these substances to "prevent, repel or mitigate any pest." These substances are also "pesticide chemical residues" under the Federal Food, Drug, and Cosmetic Act (FFDCA). The proposed criteria were intended to clearly identify and exempt only those residues for which a long history of safe exposure and consumption can support exemption. EPA believes there is a reasonable certainty that no harm will result from aggregate exposure to such residues, including all anticipated dietary exposures and all other exposures for which there is reliable information. Therefore, EPA is concurrently considering the exemption of plant-incorporated protectants based on viral coat protein genes from the requirement of a tolerance under section 408 of the FFDCA. Due to public interest and new scientific information, additional public comment on this proposal (originally published in 1994) was requested in 2001. After considering public comment and additional review by the Science Advisory Panel, EPA issued a reproposal in 2007. 
Agency: Environmental Protection Agency(EPA)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 174   
Legal Authority: 21 USC 346(a) et seq    7 USC 136 et seq   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM Original  11/23/1994  59 FR 60496   
Supplemental NPRM 1  07/22/1996  61 FR 37891   
Supplemental NPRM 2  05/16/1997  62 FR 27132   
Supplemental NPRM 3  04/23/1999  64 FR 19958   
Supplemental NPRM 4  07/19/2001  66 FR 37855   
Reproposal  04/18/2007  72 FR 19589   
Final Action  To Be Determined    
Additional Information: EPA publication information: Reproposal - http://www.epa.gov/fedrgstr/EPA-PEST/2007/April/Day-18/p7297.htm; EPA Docket information: EPA-HQ-OPP-2006-0642
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/pesticides/biopesticides/pips/index.htm  
Sectors Affected: 111 Crop Production; 32532 Pesticide and Other Agricultural Chemical Manufacturing; 54171 Research and Development in the Physical Sciences and Engineering Sciences 
RIN Data Printed in the FR: No 
Agency Contact:
Kenneth Haymes
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7202M,
Washington, DC 20460
Phone:202 564-0306
Fax:202 564-8502
Email: Haymes.Kenneth@epa.gov

Tom McClintock
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
7202M,
Washington, DC 20460
Phone:202 564-8488
Email: mcclintock.tom@epa.gov