['RE', '-', '--', '“INBIFO', 'Institut', 'fr', 'biologische', 'Forschung', 'GmbH', '-', 'KéIn', 'PRIORITY', '13', 'Sep.', '96', 'JOE/MHA', 'XARE\\MISC\\REV_EPA.DOC', 'Page', '1', 'Comments', 'on:', '“A', 'Review', 'of', 'the', 'California', 'Environmental', 'Protection', 'Agency’s', 'Risk', 'Assessment', 'Practices,', 'Policies,', 'and', 'Guidelines”', 'Version:', 'Public', 'Review', 'Draft,', '24', 'May', '96', '2505163441', 'The', 'timing', 'of', 'the', 'Peer', 'Review', 'is', 'not', 'well', 'chosen', 'The', 'main', 'objective', 'of', 'the', 'Peer', 'Review', 'is', 'to', 'assess', 'the', 'appropriateness', 'of', 'any', 'inconsistencies', 'between', 'the', 'risk', 'assessment', 'practices', 'of', 'California', 'Environmental', 'Protection', 'Agency', '(Cal/EPA)', 'and', 'those', 'of', 'the', 'U.S.', 'Environmental', 'Protection', 'Agency', '(U.S.', 'EPA).', 'However,', 'a', 'month', 'earlier', 'than', 'this', 'Peer', 'Review,', 'the', 'U.S.', 'EPA', 'proposed', 'novel', 'guidelines', 'for', 'carcinogen', 'risk', 'assessment', '(23', 'Apr.96).', 'That', 'means', 'the', 'U.S.', 'EPA', 'will', 'change', 'practices', 'accordingly.', 'Sooner', 'or', 'later', 'the', 'Cal/EPA', 'will', 'have', 'to', 'change', 'its', 'practices,', 'for', 'instance,', 'by', 'adopting', 'the', 'new', 'U.S.', 'EPA', 'guidelines.', 'Thus,', 'the', 'significance', 'of', 'the', 'present', 'Peer', 'Review', 'may', 'be', 'limited.', 'The', 'Peer', 'Review', 'considers', 'smokers', 'as', 'sensitive', 'populations', 'Regarding', 'the', 'issue', 'of', 'sensitive', 'populations,', 'the', 'Peer', 'Review', 'gives', 'credit', 'to', 'Cal/EPA', 'for', 'being', '-', 'ahead', 'of', 'U.S.', 'EPA', 'in', 'developing', 'procedures', 'to', 'identify', 'hazards', 'for', 'sensitive', 'populations.', 'This', 'represents', 'a', 'new', 'area', 'of', 'regulatory', 'assessment.', 'Up', 'to', 'now,', 'cancer', 'risk', 'assessment', 'guidelines', 'have', 'been', 'assuming', 'that', 'all', 'members', 'of', 'the', 'population', 'have', 'equivalent', 'responses', 'and', 'that', 'risk', 'assessments', 'for', 'noncarcinogens', 'account', 'for', 'response', 'variability', 'by', 'dividing', 'by', 'an', 'uncertainty', 'factor.', 'The', 'Peer', 'Review', 'by', 'stating', '“Smokers', 'may', 'have', 'prior', 'restrictions', 'in', 'pulmonary', 'function”', 'considers', 'smokers,', 'in', 'addition', 'to', 'infants,', 'children,', 'the', 'elderly,', 'and', 'members', 'of', 'various', 'ethnic', 'groups', 'also', 'as', 'a', 'sensitive', 'population.', 'Thus,', 'in', 'the', 'future', 'we', 'may', 'face', 'complicated', 'risk', 'assessments', 'related', 'to', 'cigarette', 'smoking', 'in', 'view', 'of', 'the', 'polymorphism', 'of', 'many', 'xenobiotic', 'detoxifying', 'enzymes.', 'For', 'example,', 'the', 'polymorphically', 'existing', 'CYP1A1', '(lung', 'cancer', 'risk),', 'CYP1A2', '(colorectal', 'cancer', 'risk),', 'CYP2D6', '(lung', 'cancer', 'risk),', 'and', 'glutathione-S-', 'transferase-p', '(lung', 'and', 'bladder', 'cancer', 'risk)', 'have', 'been', 'linked', 'to', 'cigarette', 'smoke', 'exposure.', 'In', 'addition,', 'susceptibility', 'factors', 'in', 'combination', 'with', 'biomarkers', 'may', 'come', 'into', 'common', 'use', 'in', 'risk', 'assessments,', 'even', 'when', 'information', 'on', 'health', 'outcome', 'is', 'lacking.', 'However,', 'the', 'position']