. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/473
26 July 2001
(01-3748)
Committee on Sanitary and 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 number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, where applicable).
Regions or countries likely to be affected, to the extent relevant or practicable:  Nucleic
acid
4. Title and number of pages of the notified document:  Exemption From the Requirement of a
Tolerance Under the Federal Food, Drug, and Cosmetic Act for Residues of Nucleic Acids that
are Part of Plant-Incorporated Protecta nts (Formerly Plant-Pesticides) (14 pages)
5. Description of content:   The substances plants produce for protection against pests, and the
genetic material necessary to produce these substances, are pesticides under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if humans intend to use these substances
for "preventing, destroying, repelling or mitigat ing any pest".  These substances, produced and
used in living plants, along with the genetic material necessary to produce them, are also
"chemical pesticide residues" under the Federal Food, Drug, and Cosmetic Act (FFDCA).  The
Environmental Protection Agency (EPA) calls these substances along with the genetic material
necessary to produce them, "plant-incorporated protectants".  In this final rule, EPA exempts
from the FFDCA section 408 requirement of a tolerance, residues of nucleic acids that are part
of a plant-incorporated protectant.  Nucleic acids are ubiquitous in all forms of life, have
always been present in human and domestic animal food and are not known to cause anyadverse health effects when consumed as part of food.  EPA believes there is a reasonable
certainty that no harm will result from aggregate exposure to residues of nucleic acids that are
part of a plant-incorporated protectant.
6. Objective and rationale: [  X ] food safety,  [     ] animal health,  [     ] plant protection,
[    ] protect humans from animal/plant pest or disease, [     ] protect territory from other
damage from pests           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  66 FR 37817,
19 July 2001 (Available in English)
9. Proposed date of adoption:  This regulation is effective 17 September 2001.G/SPS/N/USA/473
Page 2
10. Proposed date of entry into force:  This regulation is effective 17 September 2001.
11. Final date for comments:  Objections and requests for hearings must be received by EPA on
or before 17 September 2001.
Agency or authority designated to handle comments:  [     ] National notification authority,
[    ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:  Detailed instruction on where and how to send comments is in the body of the
full text - which will be sent upon request to the address in paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point or
address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
Attn:  Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C.20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov