. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1555 
23 May 2007  
 (07-2100) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
NOTIFICATION  
 
1. Member to Agreement notifying:  UNITED STATES   
If applicable, name of local government involved:   
2. Agency responsible:  Environmental Protection Agency (EPA) 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Various  
4. Regions or countries likely to be affected, to the extent relevant or practicable :  Any 
US trade partners  
5. Title, language and number of pages of the notified document:  PROPOSED RULE .  
Exemption Under the Federal Insecticide, Fungi cide, and Rodenticide Act for Certain Plant-
Incorporated Protectants Derived From Plant Viral Coat Protein Gene(s) (PVCP-PIPs); 
Supplemental Proposal (avail able in English, Number of Pages:  52 / 21) 
6. Description of content:  
EPA is proposing an exemption from federal regul ation for certain plant virus coat protein 
plant-incorporated protectants or "PVCP-PIPs".  EPA is propos ing to define a PVCP-PIP as 
"a plant-incorporated protectant derived from one or more genes that encode a coat protein of a virus that naturally infects plants.  This includes plant-incorporat ed protectants derived 
from one or more plant viral coat protein genes that produc e only RNA and no virus-related 
protein".  PVCP-PIPs introduced into plants with the intention of preventing or mitigating 
viral disease meet the definition of "pesticide" as per relevant federal statutes because they 
are introduced into plants with the intenti on of "preventing, destroying, repelling, or 
mitigating any pest ..." and plant viruses meet de finition of "pest" according to the relevant 
federal statute. EPA is proposi ng this exemption because the Agency believes that the PVCP-
PIPs covered by this exemption would be of a ch aracter which is unnecessa ry to be subject to 
federal regulation in order to carry out the purposes of the EPA’s mandate. 
 EPA is further proposing to exempt the following from the federal requirement of a tolerance:  Residues of coat proteins from viruses that naturally infect plants that humans 
consume as part of a normal diet, including an y metabolites or degrad ates of those coat 
proteins, when such coat proteins are produced in living plants as part of a PIP and the criteria proposed for this exemption are met.  The proposed criteria are intended to clearly 
identify and exempt only those residues for which a long history of safe exposure and 
consumption can support exemption.  EPA beli eves 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 ther e is reliable information.  This proposed 
exemption would eliminate the need to establ ish a maximum permissible level in food for 
these residues.  G/SPS/N/USA/1555 
Page 2  
 
  7. Objective and rationale:  [ X ] food safety, [ ] animal health, [ X ] plant protection, 
[ X ] protect humans from animal/plant pest or disease,  [ X ] protect territory from other damage from pests 
8. International standard, guideline or recommendation:  
[ ] Codex Alimentarius Commission, [ ] World Organization for Animal Health (OIE), [ 
] International Plant Protec tion Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
  
9. Relevant documents and language(s ) in which these are available:  
Federal Register: 18 April 2007 (Volume 72, Number 74) Proposed Rules Page 19589-
19640; 
http://www.epa.gov/fedrgstr/EPA -PEST/2007/April/Day-18/p7297.htm 
Federal Register: 18 April 2007 (Volume 72, Number 74) Proposed Rules Page 19640-
19660; http://www.epa.gov/fedrgstr/EPA -PEST/2007/April/Day-18/p7296.htm 
10. Proposed date of adoption:   N/A 
11. Proposed date of entry into force:   This is a proposed rule which may or may not result in 
further regulatory action. 
12. Final date for comments:  Comments must be received on or before 17 July 2007, and may 
be identified by docket number EP A-HQ-OPP-2006-0642 or EPA-HQ-OPP-2006-0643. 
Agency or authority designated to handle comments:  [ ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:   Registration Division, (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Penn sylvania Ave., NW., Washington, DC 20460-
0001 
13. Texts available from:  [ X ] National notification authority, [ ] National enquiry point, 
or address, fax number and E-mail a ddress (if available) of other body:   United States 
SPS National Notification Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Divisi on (IRSD), Stop 1027, Washington D.C. 20250;  Tel:  +(1 
202) 720-1301;  Fax:  +(1 202) 690- 0677;  E-mail:  fstsd@fas.usda.gov