['‘The', 'existing', 'spinosad', 'tolerances', 'resulted', 'in', 'a', 'Theoretical', 'Maximum', 'Residue', 'Contribution', '(TMRC)', 'that', 'is', 'equivalent', 'to', 'the', 'following', 'percentages', 'of', 'the', 'RED:', 'U.S.', 'population', '(24%', 'of', 'RfD),', 'nursing', 'infants', '(<', '1', 'year', 'old)(8%', 'of', 'R£D);', 'non-', 'nursing', 'infants', '(<', '1', 'year', 'old)', '(24%', 'of', 'R£D);', 'children', '(1-6', 'years', 'old)', '(34%', 'of', 'RID);', 'children', '(7-12', 'years', 'old)', '(29%', 'of', 'RD);', 'Northeast', 'Region', '(25%', 'of', 'R£D);', 'Western', 'Region', '(27%', 'of', 'RfD);', 'Non-Hispanic', 'Blacks', '(27%', 'of', 'Rf£D);', 'Non-', 'Hispanic', 'others', '(37%', 'of', 'RED);', 'females', '13+', 'years,', 'nursing', '(27%', 'of', 'RED).', 'The', 'Agency', 'believes', 'that', 'the', 'addition', 'of', 'a', '0.02', 'ppm', 'tolerance', 'for', 'spinosad', 'on', 'coffee', 'will', 'only', 'change', 'the', 'percent', 'of', 'the', 'R&D', 'used', 'for', 'any', 'of', 'the', 'categories', 'listed', 'above', 'by', 'less', 'than', '1%.', 'This', 'is', 'based', 'on', 'the', 'fact', 'that', 'the', 'use', 'will', 'be', 'limited', 'to', '80', 'acres', 'in', 'Hawaii', 'for', 'experimental', 'purposes', 'for', 'period', 'of', 'time', 'not', 'to', 'exceed', '2', 'years.', '2.', 'From', 'drinking', 'water.', 'The', 'Agency', 'has', 'determined', 'that', 'spinosyns', 'Factor', 'A', 'and', 'Factor', 'D-:¢e', 'immobile', 'in', 'soil', 'and', 'will', 'not', 'leach', 'into', 'ground', 'water.', 'Based', 'on', 'structure/activity', 'relationships,', 'the', 'Agency', 'concluded', 'that', 'the', 'spinosad', 'metabolites/fermentation', 'impurities', '(spinosyns', 'Factor', 'B,', 'Factor', 'B', 'of', 'D,', 'Factor', 'K,', 'and', 'other', 'related', 'Factors)', 'were', 'of', 'no', 'more', 'toxicological', 'concern', 'than', 'the', 'two', 'parent', 'compounds', '(spinosyns', 'Factor', 'A', 'and', 'Factor', 'D)', 'and', 'therefore,', 'only', 'these', 'were', 'considered', 'in', 'the', 'drinking', 'water', 'assessment.', 'EPA', 'used', 'the', '“Interim', 'Approach', 'for', 'Addressing', 'Drinking', 'Water', 'Exposure', 'in', 'Tolerance', 'Decision', 'Making"', 'issued', 'on', '11/17/97.', 'Thus,', 'the', 'PRZM/EXAMS', 'Models', 'were', 'run', 'to', 'produce', 'estimates', 'of', 'spinosad', 'in', 'surface', 'water.', 'The', 'primary', 'use', 'of', 'these', 'models', 'is', 'to', 'provide', 'a', 'screen', 'for', 'sorting', 'out', 'pesticides', 'for', 'which', 'OPP', 'has', 'a', 'high', 'degree', 'of', 'confidence', 'that', 'the', 'true', 'levels', 'of', 'the', 'pesticide', 'in', 'drinking', 'water', 'will', 'be', 'less', 'than', 'the', 'human', 'health', 'drinking', 'water', 'levels', 'of', 'concem', '(DWLOCs).', 'A', 'human', 'health', 'DWLOC', 'is', 'the', 'concentration', 'of', 'a', 'pesticide', 'in', 'drinking', 'water', 'which', 'would', 'result', 'in', 'acceptable', 'aggregate', 'risk,', 'after', 'having', 'already', 'factored', 'in', 'all', 'food', 'exposures', 'and', 'other', 'non-occupational', 'exposures', 'for', 'which', 'OPP', 'has', 'reliable', 'data,', 'PRZM/EXAMS', 'was', 'used', 'to', 'conduct', 'a', 'Tier', '2', 'surface', 'water', 'analysis,', 'The', 'Tier', '2', 'estimated', 'drinking', 'water', 'concentration', '(EEC)', 'of', 'spinosad', 'from', 'surface', 'water', 'sources', 'is', 'not', 'likely', 'to', 'exceed', '0.059', '[mu]g/l', 'from', 'use', 'on', 'apples,', '0.092', '[mu]g/|', 'from', 'use', 'on', 'Brassica', 'vegetables,', '0.065', '[mu]g/l', 'from', 'use', 'on', 'cotton,', 'and', '0.075', '[mu]g/l', 'from', 'use', 'on', 'citrus.', 'i,', 'Acute', 'exposure', 'and', 'risk.', 'Because', 'no', 'acute', 'dietary', 'endpoint', 'was', 'determined,', 'the', 'Agency', 'concludes', 'that', 'there', 'is', 'a', 'reasonable', 'certainty', 'of', 'no', 'harm', 'from', 'acute', 'exposure', 'from', 'drinking', 'water.', 'ii,', 'Chronic', 'exposure', 'and', 'risk,', 'Based', 'on', 'the', 'chronic', 'dietary', '(food)', 'exposure', 'and', 'using', 'default', 'body', 'weights', 'and', 'water', 'consumption', 'figures,', 'chronic', 'drinking', 'water', 'levels', 'of', 'concern', '(@WLOC)', 'were', 'calculated,', 'The', 'chronic', 'drinking', 'water', 'exposure', 'and', 'risk', 'estimates', 'are', '0.019890', 'mg/kg/day', '(690', '[mu]g/', 'DWLOC)', 'for', 'the', 'overall', 'U.S.', 'population;', '0.01896', 'mg/kg/day', '(570', '[mu]g/', 'DWLOC)', 'for', 'females', '13+', 'years,', 'nursin,', ';', 'and', '0.016865', 'mg/kg/day', '(170', '[mu]e/l', 'DWLOC)', 'for', 'children', 'age', '1-6', 'years.', '3.', 'From', 'non-dietary', 'exposure.', 'There', 'are', 'no', 'current', 'residential', 'uses', 'for', 'spinosad.', 'However,', 'the', 'proposed', 'use', 'of', 'a', '0.5%', 'spinosad', 'product', 'on', 'structural', 'lumber', 'may', 'have', 'residential', 'uses.', 'This', 'product', 'is', 'injected', 'into', 'drilled', 'holes', 'and', 'then', 'sealed', 'after', 'treatment.', 'Duc', 'to', 'the', 'lack', 'of', 'toxicity', 'endpoints', '(hazard)', 'and', 'minimal', 'contact', 'with', 'the', 'active', 'ingredient', 'during', 'and', 'after', 'application,', 'exposure', 'to', 'residential', 'occupants', 'is', 'not', 'expected.', '4.', 'Cumulative', 'exposure', 'to', 'substances', 'with', 'common', 'mechanism', 'of', 'toxicity.', 'Spinosad', 'has', 'not', 'yet', 'been', 'grouped', 'with', 'any', 'other', 'insecticides', 'into', 'a', 'class.', 'Section', '408(b)(2)(D)(v)', 'requires', 'that,', 'when', 'considering', 'whether', 'to', 'establish,', 'modify,', 'or', 'revoke', 'a', 'tolerance,', 'the', 'Agency', 'consider', '“available', 'information”', 'concerning', 'the', 'cumulative', 'effects', 'of', 'a', 'particular', "pesticide's", 'residues', 'and', '“other', 'substances', 'that', 'have', 'a', 'common', 'mechanism', 'of', 'toxicity."', 'The', 'Agency', 'believes', 'that', '"available', 'information"', 'in', 'this', 'context', 'might', 'include', 'not', 'only', 'toxicity,', 'chemistry,', 'and', 'exposure', 'data,', 'but', 'also', 'scientific', 'policies', 'and', 'methodologies', 'for', '[*43634]', 'understanding', 'common', 'mechanisms', 'of', 'toxicity', 'and', 'conducting', 'cumulative', 'risk', 'assessments.', 'For', 'most', 'pesticides,', 'although', 'the', 'Agency', 'has', 'some', 'information', 'in', 'its', 'files', 'that', 'may', 'tum', 'out', 'to', 'be', 'helpful', 'in', 'eventually', 'determining', 'whether', 'a', 'pesticide', 'shares', 'a', 'common', 'mechanism', 'of', 'toxicity', 'with', 'any', 'other', 'substances,', 'EPA', 'does', 'not', 'at', 'this', 'time', 'have', 'the', 'methodologies', 'to', 'resolve', 'the', 'complex', 'scientific', 'issues', 'concerning', 'common', 'mechanism', 'of', 'toxicity', 'in', 'a', 'meaningful', 'way.', 'EPA', 'has', 'begun', 'a', 'pilot', 'process', 'to', 'study', 'this', 'issue', 'further', 'through', 'the', 'examination', 'of', 'particular', 'classes', 'of', 'pesticides.', 'The', 'Agency', 'hopes', 'that', 'the', 'results', 'of', 'this', 'pilot', 'process', 'will', 'increase', 'the', "Agency's", 'scientific', 'understanding', 'of', 'this', 'question', 'such', 'that', 'EPA', 'will', 'be', 'able', 'to', 'develop', 'and', 'apply', 'scientific', 'principles', 'for', 'better', 'determining', 'which', 'chemicals', 'have', 'a', 'common', 'mechanism', 'of', 'toxicity', 'and', 'evaluating', 'the', 'cumulative', 'effects', 'of', 'such', 'chemicals.', 'The', 'Agency', 'anticipates,', 'however,', 'that', 'even', 'as', 'its', 'understanding', 'of', 'the', 'science', 'of', 'common', 'mechanisms', '2G29', 'PGtcs']