. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/472
26 July 2001
(01-3750)
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: Plant-
incorporated protectants
4. Title and number of pages of the notified document:  Regulations Under the Federal
Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants (Formerly
Plant-Pesticides) (47 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, repelling or mitigating any pest ".  In this rule, the Environmental Protection
Agency (EPA) finalizes certain of the proposed rules published in 1994, 1996, and 1997.
Specifically, EPA changes the name of this type of pesticide from "plant-pesticide" to
"plant-incorporated protectant", clarifies the relationship between plants and plant-incorporated
protectants under FIFRA; exempts from FIFRA requirements plant-incorporated protectants
derived through conventional breeding from sexually compatible plants;  and establishes a new
part in the Code of Federal Regulations (CFR) specifically for plant-incorporated protectants.
Procedures are also set forth for Confidential  Business Information (CBI);  any claim of
confidentiality must be substantiated when the claim is made.  This rule will benefit the public
by ensuring that public health and the environment are adequately protected while reducing
burden on the regulated community, thereby potentially reducing costs for consumers.
This final rule establishes certain basic parameters of EPA's regulatory programme under
FIFRA for plant-incorporated protectants.  In this rule, EPA defines the scope of productssubject to FIFRA jurisdiction, and identifies the category of products over which it will exert
regulatory oversight.  EPA also establishes certain fundamental definitions to clarify what will
be subject to regulation as a plant-incorporated protectant. The rule also finalizes certain
regulatory procedures specific to plant-incorporated protectants.
This document also provides some guidance on the way in which the Agency intends to
interpret the existing regulations for these products until it is able to establish additional
regulations specific to plant-incorporated protectants.  Specifically, the rule clarifies that plants
used as biological control agents remain exempt from FIFRA requirements, but that
plant-incorporated protectants are not.  Second, the rule exempts plant-incorporated protectants
derived through conventional breeding from sexually compatible plants.  Third, this final ruleestablishes a new 40 CFR part 174, specifically for plant-incorporated protectants; any
additional regulations specific to plant-incorporated protectants will be codified in 40 CFRG/SPS/N/USA/472
Page 2
part 174.  The final rule also imposes a requirement at Sec. 174.71, that any person producing
an otherwise exempt plant-incorporated protectant for sale and distribution, who obtains any
information regarding adverse effects of this otherwise exempt plant-incorporated protectant on
human health or the environment report that in formation to EPA.  Finally, the rule includes a
provision that any claim of confidentiality must be made at the time of submission andsubstantiated at the time the claim is made.
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 37771,
19 July 2001 (Available in English)
9. Proposed date of adoption:  This rule is effective 17 September 2001.
10. Proposed date of entry into force:  This rule is effective 17 September 2001.
11. Final date for comments:
Agency or authority designated to handle comments: Environmental Protection Agency
[    ] National notification authority, [     ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:  The full text of this final rule 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 BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C.20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov