. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/257 
17 April 2007 
 (07-1560) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Environmental Protection Agency (EPA) (264) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Pesticides  
(HS:  3808;  ICS:  65.100, 67.230, 67.250) 
5. Title, number of pages and langua ge(s) of the notified document:   Pesticides; Food 
Packaging Treated with a Pesticide (4 pages, in English). 
6. Description of content:   This proposed rule would except from the definitions of "pesticide 
chemical" and "pesticide chemical residue " under FFDCA section 201(q), food packaging 
(e.g. paper and paperboard, co atings, adhesives, and polymers) that is treated with a 
pesticide as defined in the Federal Insectic ide, Fungicide and Rodenticide Act (FIFRA) 
section 2(u).  As a result, such ingredients in  food packaging treated with a pesticide would 
be exempt from regulation under FFDCA se ction 408 as pesticide chemical residues. 
Further, a food that bears or contains such ingredients would not be subject to enforcement 
by the Food and Drug Administration (FDA) under section 402(a)(2) (B) of the FFDCA 
since the ingredients would no longer be p esticide chemical resi dues.  Instead, such 
ingredients would be subject to regulation by the FDA as food additives under FFDCA 
section 409.  FDA generally regulates such food additives in food packaging as food contact 
substances under FFDCA, section 409(h).  This proposed rule would expand the scope of 
the provision in 40 CFR 180.4 which currently applies only to food packaging impregnated 
with an insect repellent - one type of pesticide.   This proposed rule, as with the rule it would 
amend, only applies to the food packaging ma terials themselves; it would not otherwise 
limit EPA's FFDCA jurisdiction over pesticides or limit FDA's jurisdiction over substances 
subject to FDA regulation as food additives.  EPA, in consultation with FDA, and FDA 
believe this rule would eliminate the dupli cative FFDCA jurisdiction and economise federal 
government resources while continuing to protect  human health and the environment.  Even 
after this rule is finalized, under the Federa l Insecticide, Fungicide and Rodenticide Act 
(FIFRA), EPA would continue to regulate the food packaging as an inert ingredient of the 
pesticide product and regulate the pesticide activ e ingredient in the treated food packaging 
under both FIFRA and the FFDCA.  The text of th is proposed rule is identical to a direct 
final rule EPA issued on 6 December 2006.  EPA received several comments opposing that 
direct final rule and therefore withdrew th e rule on 25 January 2007, consistent with EPA 
policy.  EPA is now issuing the rule as a proposal for public comment. G/TBT/N/USA/257 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human life and health 
8. Relevant documents:   72 Federal Register (FR) 17068 6 April 2007; Title 40 Code of 
Federal Regulations (CFR) Part 180.  Will app ear in the Federal Register when adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   23 April 2007 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Internet URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/E7-
6349.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20071800/edocket.access.gpo.gov/2007/pdf/
E7-6349.pdf