OASIS :OASIS Manufacturer Country: Egypt Product code: 24FGD02 Importers product description: Okra Large Refusal date: 27-AUG-2008 FDA_District: NYK-DO FDA sample analysis: Yes FDA record of private lab sample analysis: No Charge(s): PESTICIDES


Charge :Charge PESTICIDES 402(a)(2)(B), 802(a)(B); The article is subject to ADULTERATION refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:


FDA’s Pesticide Program :FDA’s Pesticide Program


Regulation of Pesticides :Regulation of Pesticides EPA: FIFRA - Registers Use of Pesticides FFDCA - Establishes tolerances FDA: Compliance with Tolerance in Food USDA/FSIS: Compliance with Tolerance in Meat and Poultry


FDA Residue Monitoring Program :FDA Residue Monitoring Program Regulatory Monitoring: Enforce Tolerances Incidence/Level Monitoring Specific Commodity/Pesticide Total Diet Study (Market Basket Survey) Estimate Dietary Exposure


FDA Regulatory Monitoring Program :FDA Regulatory Monitoring Program Import – Point of entry Domestic – Point of production ~ 7,500 Samples Each Year ~ 400 Pesticide Chemicals


FDA Regulatory Monitoring Program- Violative Samples :FDA Regulatory Monitoring Program- Violative Samples Illegal Residues > EPA Tolerances No EPA Tolerances Domestic – Invoke Sanctions seizure, injunction Import – Refuse admission Detention Without Physical Examination (DWPE)


FDA Regulatory Monitoring Program- Factors in planning samples :FDA Regulatory Monitoring Program- Factors in planning samples Review of residue data Pesticide use Dietary importance of food Foods consumed by infants & children Volume in commerce Toxicity & characteristics of pesticides


Incidence/Level Monitoring Program :Incidence/Level Monitoring Program Aquaculture Survey, FY 90 - 94 Milk Survey, FY 90 - 93 US Manufactured Pesticides (Circle of Poisons), FY 94 Foods Eaten by Infants & Children, FY 94 - Statistically Based Surveys, FY 93 - 95 Triazine Herbicides, FY 95 Wheat Imported from Canada, FY 99 Forchlorfenuron on Mexican Grapes, FY 99 Canola – Dom & Imp from Canada, FY 00 Dietary supplement ginseng, FY 02 – 03 Dietary supplements, FY 04, 06, 07


Total Diet Study Objectives :Total Diet Study Objectives Estimate dietary intakes – 14 age/sex groups Identify trends and changes in the levels


Total Diet Study Revised 2003 :Total Diet Study Revised 2003 USDA’s National Food Consumption Surveys >3,500 Foods Identified 282 Foods Selected Analysis of individual foods as eaten Modified analytical methods (1 – 2 ppb range for many)


TDS – Population Groups :TDS – Population Groups 6 – 11-month-old infants 2-year-old children 6-year-old children 10-year-old children 14 – 16-year-old females & males 25 – 30-year-old females & males 40 – 45-year-old females & males 60 – 65-year-old females & males 70+ -year-old females & males


TDS – 4 regional market baskets :TDS – 4 regional market baskets


Total Diet StudyFood Purchases :Total Diet StudyFood Purchases 4 times per year Local grocery stores Each market basket – 3 cities in a given region


TDS - Analytes :TDS - Analytes Pesticide residues Radionuclides Industrial chemicals Toxic elements Trace and macro elements Folate


Total Diet StudySummary of Findings :Total Diet StudySummary of Findings ~ 300 Pesticide chemicals ~ 70 chemicals found Estimated Intakes < FAO/WHO’s ADIs < EPA’s RDs Rarely exceed 1% of ADIs


CFSAN – Pesticide Programhttp://www.cfsan.fda.gov/~lrd/pestadd.html :CFSAN – Pesticide Programhttp://www.cfsan.fda.gov/~lrd/pestadd.html Annual reports Residue monitoring databases Glossary of pesticide chemicals Pesticide analytical behavior data Pesticide analytical manuals (PAM I & II) Total Diet Study residue data