WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2357 
2 May 2012  
 (12-2317) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES 
If applicable, name of local government involved:    
2. Agency responsible:  US Environmental Protection Agency 
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):  multiple 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Fluopyram; Pesticide Tolerances  Language(s):  English  
Number of pages:  9 
http://www.gpo.gov/fdsys/pkg/FR-2012-02-24/html/2012-4321.htm   
6. Description of content:  This regulation establishes tolerances for residues of fluopyram in 
or on multiple commodities. 
(a) General 
(1) Tolerances are established for residues of  the fungicide fluopyram, N-[2-[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide,including its metabolites and degradates in or on the commodities in the table below.  Compliance with the tolerance 
levels specified in the table is to be determ ined by measuring only fluopyram in or on the 
commodity. 
Commodity     Parts  per million 
Almond, hull     8.00 
Apple      0.30 
Apple, wet pomace    0.60 
Banana\1\     1.00 
Bean, dry     0.09 
Beet, sugar, root    0.04 
Cherry      0.60 
Grape, wine     2.00 
Nut, tree, group 14    0.05 
Peanut      0.02 
Pistachio     0.05 
Potato      0.02 
Potato, processed potato waste   0.08 G/SPS/N/USA/2357 
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  Strawberry     1.50 
Watermelon     1.00 
 
\1\ There are no U.S. registrations. 
(2) Tolerances are established for residues of  the fungicide fluopyram, N-[2-[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide,including its metabolites 
and degradates.  Compliance with the tolerance le vels specified in the table below is to be 
determined by measuring only the sum of fluopyram and its metabolite, 2-(trifluoromethyl) benzamide, calculated as the stoichiometric  equivalent of fluopyram, in or on the 
commodity. 
Commodity     Parts  per million 
Cattle, fat     0.11 
Cattle, meat     0.15 
Cattle, meat by-products   1.10 
Egg     0.25 
Goat, fat     0.11 
Goat, meat     0.15 
Goat, meat by-products    1.10 
Hog, fat     0.05 
Hog, meat     0.05 
Hog, meat by-products    0.70 
Horse, fat     0.11 
Horse, meat     0.15 
Horse, meat by-products   1.10 
Milk      0.07 
Poultry, fat     0.20 
Poultry, meat     0.15 
Poultry, meat by-products   0.60 
Sheep, fat     0.11 
Sheep, meat     0.15 
Sheep, meat by-products   1.10 
(b) Section 18 emergency exemptions. [Reserved] 
(c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. It is recommended that tolerances be established for 
indirect or inadvertent residues of fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-
2-pyridinyl]ethyl]-2-(trifluoromethyl)benzami de, including its metabolites and degradates, 
in or on the commodities in the table below.  Compliance with the tolerance levels specified 
in the table is to be determined by measu ring only fluopyram in or on the commodity. 
Commodity     Parts  per million 
Alfalfa, forage     0.45 
Alfalfa, hay     1.10 
Canola, seed     1.80 
Cotton, gin by-products    0.05 
Cotton, undelinted seed    0.01 
Grain, cereal, forage, fodder and    
straw, group 16, except rice; forage  4.00 
Grain, cereal, forage, fodder and   7.00 
straw, group 16, except rice; hay, straw and stover Grain, cereal, group 15, except rice  1.50  G/SPS/N/USA/2357 
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  Soybean, forage     4.00 
Soybean, hay     15 
Soybean, seed     0.10 
7. 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.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [X] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:  Codex Maximum Residue Limits (CXLs) have been established 
for grape at 2 ppm and dried grapes (raisins) at 5 ppm;  milk at 0.07 ppm;  mammalian meat at 0.1 ppm, and edible offal mammalian (meat by-products) at 0.7 ppm.  For the purpose of international harmonization, EPA is establishing U.S. tolerances for wine grape at 2.0 ppm 
(raised from 1.4 ppm);  milk at 0.07 ppm (raised from 0.06 ppm);  and hog meat by-
products at 0.70 ppm (raised from 0.45 ppm).  The Codex MRL for grapes is based on field 
trials conducted in Europe, and is calculated by rounding up of the statistically determined 
1.3 ppm to 2 ppm.  A U.S. tolerance for dried gr apes (raisins) is not needed as the tolerance 
request is for wine-type grapes only, which are not converted to raisins.  Harmonization of recommended U.S. tolerances for meat and meat  by-products (other than hog) with Codex 
MRLs cannot be achieved.  The Codex MRL for livestock is calculated on the basis of the 
diets listed in Annex 6 of the 2009 JMPR Re port (OECD Feedstuffs Derived from Field 
Crops) and the use of a reasonable worst case diet/feed approach (RWCF).  The dietary burden was calculated using only grape pomac e residue and 20% contribution to the 
Australian dairy and beef cattle diets.  The U.S. tolerance was based on guidance 
"Revisions of Feedstuffs in (Table 1) OPPTS Test Guideline 860.1000" and "Guidance on 
Constructing Maximum Reasonably Balanced  Diets (MRBD)".  Based on the U.S. 
livestock diets (which does not include grape pomace) and the cattle feeding study, the 
meat by-product (cattle, goat horse, sheep) tole rances need to be set at 1.1 ppm, a higher 
level than the 0.7 Codex MRL for edible offal. Similarly, the U.S. m eat tolerances for these 
animals need to be set higher than the Codex MRL (0.15 versus 0.1 ppm). 
9. Other relevant documents and language (s) in which these are available:      
10. Proposed date of adoption (dd/mm/yy) :  24 February 2012 
Proposed date of publication (dd/mm/yy) :  24 March 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  24 February 2012  
[X] Trade facilitating measure   G/SPS/N/USA/2357 
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  12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  Not applicable 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Lisa Jones, Registration Division, Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001;  Tel:  (703) 308-9424;  Email:  jones.lisa@epa.gov .  
13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:   United States 
SPS National Notification Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD),  Stop 1014, Washington D.C. 20250.  Tel: 
202-720-1301;  Fax:  202-720-0433;  Email:  us.spsenquirypoint@fas.usda.gov