Glyphosate Human - Health Risk Assessment D3 8 753 5

Page 2 of 3 expression is for residues of only glyphosate to 180.364(a)(2) where the tolerance expression is for combined residues of glyphosat e and N - acetyl - glyphosate (expressed in glyphosate equivalents). Provided the petitioner submits a revised Section B specifying a 30 - day plantback interval (PBI) and b ased on adequate metabolism and magnitude of the residue data, HED agrees with the pet itioner’s proposal to move the currently - established 20 - ppm canola seed tolerance from 180.364(a)(1) to 180.364(a)(2) (D394964, T. Bloem, 15 - Nov - 2011). Canadian and Codex maximum residue limits (MRLs) are currently established in/on canola seed at 10 pp m (combined residues of glyphosate and AMPA) and 20 ppm (residues of glyphosate only), respectively. HED notes that DuPont has also petitioned the Canadian Pesticide management Regulatory Agency (PMRA) concerning application of glyphosate to Optimum® GLY; PMRA indicated in a conference call that they are willing to increase the canola seed glyphosate MRL to 20 ppm. Therefore, the U.S., Canadian, and Codex tolerance levels will be harmonized but the tolerance expressions will be different. HED completed a human - health risk assessment associated with the application of glyphosate to g lyphosate - tolerant sweet corn (D372052, T. Bloem et al. , 31 - Aug - 2010). This assessment yielded an aggregate exposure to glyphosate w hich did not exceed HED's level of concer n. HED concludes that a revised human - health risk assessment is unnecessary to support the current - proposed use for the reasons listed below. ● No new toxicological data were submitted since the previous risk assessment (see D372052 (T. Bloem et al. , 31 - Aug - 2010) for a summary of the toxicological data) . ●The most recent dietary risk assessment assumed tolerance - level residues , 1 00% crop treated , and a drinking water concentration resulting from the direct application of glyphosate to water (D380165, T . Bloem, 21 - Aug - 2010). Since the current action does not result in an increase to any current tolerance , the establishment of any new tolerances , and will yield lower drinking water concentrations than those resulting from direct application to water, HED concludes that the most recent dietary risk assessment remains appropriate . ●Since no new toxicological data were submitted and a revised dietary exposure analysis is unnecessary , the previous conclusion s concerning the Food Quality Protection Act (FQPA ) Safety Factor remain s appropriate . ● HED has determined that short - , intermediate - , and long - term dermal or inhalation risks assessments are not required since toxicological concerns were not identified via these routes of exposures. Therefore, generation of an occupational exposure assessment assoc iated with proposed canola application scenario is unnecessary. ●HED does not anticipate residential exposures as a result of the proposed agricultural use. Therefore, the conclusion that aggregate exposure to glyphosate does not exceed HED’s level of c oncern made in the most recent HED human - health risk assessment remai ns appropriate ( for reference see above ). Recommendation: Provided the petitioner submits a revised Section B specifying a 30 - day PBI for all non - labeled crops following application to Optimum® GLY canola, HED concludes that the toxicological, residue chemistry, and occupational/residential exposure databases support an unconditional registration for the proposed application scenario. Attachment 1: Proposed Application Scenario. T. B loem:S10945:Potomac Yard 1:703 - 605 - 0217:7509P:RAB1Glyphosate Human - Health Risk Assessment D3 8 753 5

Page 3 of 3 Attachment 1: Proposed Application Scenarios and Requested Changes to the Proposed Labels. The petitioner submitted a proposed supplemental label for DuPontTM Abundit TM S Herbicide (EPA Reg. No. 352 - 832) which includes directions for application to DuPontTM Optimum® GLY Canola. T able 1 is a summary of the proposed end - use product and Table 2 is a summary of the proposed application scenario. Based on the currently avai lable confined/field rotational crop data, a 30 - day PBI for all non - labeled crops is appropriate following application to Optimum® GLY canola . A revised Section B is requested. Table 1 : Summary of Proposed End - Use Products. Trade Name EPA Reg. No. concentration Form . Label Date Target Crops Target Pests DuPont TM AbunditTM S Herbicide 352 - 832 glyphosate as the isopropylamine salt 4 lb ai/gal (3 lb ae/gal) water

soluble liquid not indicated DuPont TM

Optimum® GLY Canola numerous annual and

perennial grasses and broadleaf weeds Table 2 : Summary of Proposed Application Scenario for DuPont TM Optimum® GLY Canola. 1 Formulation (EPA Reg. No.) App. Timing App. Rate (lb ae/acre) Max. App.

Rate (lb ae/acre) Use Directions and Limitations

DuPont TM AbunditTM S Herbicide (EPA Reg. No. 352 - 832) broadcast preplant

or preemergence not specified 1.125 - No more than two post - emergent over - the - top applications may be made from crop emergence to the 6 - leaf stage (minimum retreatment interval of 10 days).

- Applications may be made with ground (3 - 40 gallons per acre (GPA)) or aerial (3 - 15 GPA)equipment.

- The last application must be made at least 60 days before harvest.

- The main label indicates that there are no rotational crop restric tions following application of this product.

- The main label indicates that addition of ammonium sulfate may increase product performance (17 lbs/100 gallon). emergence through 6 - leaf stage 0.234 - 0.398 0.562

1 The proposed product is not currently registered for application to canola. HED recently recommended in favor of a petition concerning the application of Roundup WeatherMAX ® (EPA Reg. No. 524 - 537) and Roundup PowerMAX ® (EPA Reg. No. 524 - 549) to Roundup Ready ® Flex Canola (D394004, T. Bloem, 15 - Sep - 2011 ).