B
Data Tables

Note: Abbreviations/acronyms included in the following data tables are included in the Glossary (see Appendix A).



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Seafood Choices: Balancing Benefits and Risks B Data Tables      Studies on Women, Infants, and Children   298      Studies on Adult Chronic Diseases   494      Recommendations for Seafood and EPA/DHA Consumption   678      FDA and US EPA Safety Levels in Regulations and Guidance   680 Note: Abbreviations/acronyms included in the following data tables are included in the Glossary (see Appendix A).

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Seafood Choices: Balancing Benefits and Risks Studies on Women, Infants, and Children TABLE B-1a Studies on Preeclampsia: Effects on Women Who Increase Seafood and/or Omega-3 Fatty Acid Intake Author Study Type Subjects Exposure Timing of Exposure Sibai, 1998 Review 3 randomized controlled trials Fish-oil supplement   Sindelar et al., 2004 Randomized Controlled Trial Men (n=8) Women (n=4) Mean age of 33 years Lincoln, NE Non-Hispanic White Recruited at YMCA marathon and triathlon training group meetings and word of mouth Exercising regularly as members of a running training group sponsored by the local YMCA No being treated with eating disorders or depression, or those unable to eat eggs, or those using medications known to affect serum lipids n-3 PUFA-enriched eggs 2 weeks baseline period, 4 weeks treatment period (crossover design), 4 weeks washout period between treatments Haugen and Helland, 2001 Randomized Controlled Trial Pregnant women (n=37) Mean age about 27-31 years Oslo, Norway Normotensive without proteinuria, had uncomplicated term pregnancies, randomly taken from another study investigating the influence of omega-3 fatty acids on fetal, neonatal, and child development Another group had moderate preeclampsia Cod-liver oil supplement 16-20 weeks gestation through pregnancy

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Seafood Choices: Balancing Benefits and Risks Amount Results Conclusion*   “The beneficial effects of fish oil on the incidence of preeclampsia are supported by observational studies and 1 large, uncontrolled early trial.” Three randomized trials “reveal no reduction in the incidence of preeclampsia in the fish oil group.” N n-3 PUFA-enriched eggs: flaxseed added to hens’ diet 350 mg n-3 PUFA/60 g egg 0.25 g LA, 0.10 g DHA/60 g egg 1 egg/day for 6 days and no eggs on day 7 Conventional eggs: 60 mg of n-3 PUFA/60 g egg 0.04 g LA, 0.02 g DHA/60 g egg 1 egg/day for 6 days and no eggs on day 7 LA, DHA, and total n-3 dietary intake of those randomized to n-3 PUFA-enriched egg treatment were significantly higher than at baseline and compared to the conventional egg treatment (p<0.05). There were no significant differences in serum total cholesterol, LDL-C and HDL-C in physically active adults from baseline to end of treatment or between groups. Serum triglycerides were significantly higher with n-3 PUFA-enriched egg treatment than those from baseline and compared to the conventional egg treatment (p<0.05). N/A Cod-liver oil group: 10 mL/day Corn oil group: 10 mL/day “The pressure increase was significant in both groups, but no significant differences in the constrictory response or in the proportions of preparations displaying dilatatory responses were observed when compared to appropriate control groups.” “Neither preeclampsia nor dietary supplementation with cod-liver oil had any significant effect on the vasoactive response to PGF2α in umbilical cord arteries.” N

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Seafood Choices: Balancing Benefits and Risks Author Study Type Subjects Exposure Timing of Exposure Salvig et al., 1996 Randomized Controlled Trial Pregnant women (n=533) Aged 18-44 years Aarhus, Denmark No history of placental abruption in an earlier pregnancy or a serious bleeding episode in the present pregnancy, no prostaglandin inhibitors regularly, no allergy to fish and regular intake of fish oil Fish-oil supplement 30th week gestation through pregnancy Onwude et al., 1995 Randomized Controlled Trial Pregnant women (n=233) Aged 18-39 years for fish oil group Aged 16-40 for placebo group Leeds, UK Multigravida with a history of one or more small babies, a history of proteinuric or nonproteinuric pregnancy-induced hypertension, or a history of unexplained stillbirth Primigravida with abnormal uterine arcuate artery Doppler blood flow at 24 weeks gestation EPA/DHA supplement Until 38th week gestation; enrollment time unspecified Bulstra-Ramakers, 1995 Randomized Controlled Trial Pregnant women (n=63) Groningen, Netherlands Birth weight below the 10th percentile in association with pregnancy-induced hypertension or chronic renal disease, or with placenta abnormalities EPA supplement 12-14 weeks gestation until delivery

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Seafood Choices: Balancing Benefits and Risks Amount Results Conclusion* Fish oil group: 2.7 g/day (4 capsules/day, each capsule contains 32% EPA, 23% DHA, 2 mg tocopherol/ml) Olive oil group: 1 g; 72% oleic acid and 12% LA/capsule 4 capsules/day Control = no capsule “Mean blood pressure increased during the course of the 3rd trimester,” but this change was not statistically different among the three groups. “No differences were seen between the groups in proportions of women with a systolic blood pressure above 140 mmHg or a systolic blood pressure above 90 mmHg, although the proportion of women with diastolic above 90 mmHg tended to be lower in the fish oil group compared to the olive oil group (RR=0.48, p=0.07).” N 2.7 g/day (1.62 g/day of EPA) (1.08 g/day of DHA) There were no significant differences between the two groups for proteinuric pregnancy-induced hypertension, nonproteinuric pregnancy-induced hypertension, birth weight, gestation length, perinatal death, duration of labor, onset of labor (spontaneous, induced, or prelabor section), or mode of delivery. N 4 capsules 3 times/day (each capsule contains 0.25 mg EPA ) vs. placebo “Addition of 3 g/day of EPA to the diet did not result in either a lowering of the incidence of pregnancy induced hypertension or intrauterine growth retardation.” “Birth weight centiles were slightly lower and the recurrence rate of pregnancy-induced hypertension was slightly higher in the EPA group,” compared to the control group, although these differences were not significant. N

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Seafood Choices: Balancing Benefits and Risks Author Study Type Subjects Exposure Timing of Exposure Schiff et al., 1993 Controlled Trial Pregnant women (n=16) Aged 25-34 years Nulliparous Nonsmokers, no history of hypertension, coagulation disorders, thrombocytopenia, or chronic vascular, renal, or other disease Fish-oil supplement 32-34 weeks through the next 21 days Olsen and Secher, 1990 Randomized Controlled Trial Pregnant women (n=5022) Aged 15-44 years London People’s League of Health, 1946 Attending antenatal clinics of 10 hospitals No disease or physical abnormality EPA/DHA supplement Enrolled at <24 weeks gestation; treatment lasts for <15 weeks (n=288), 16-19 weeks (n=411), 20-23 weeks (n=414), or 24+ weeks (n=417)

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Seafood Choices: Balancing Benefits and Risks Amount Results Conclusion* 6 capsules/day (each capsule contains 1000 mg of concentrated fish oil, 26% of which is n-3 fatty acids) “Mean excretion of 11-dehydro-thromboxane B2 before and after 21 days of fish oil consumption was reduced among the fish oil-treated women from 1606±411 pg/mg of creatinine to 779±299 pg/mg after treatment (p<0.0001, paired t test). In all 11 patients the decreased excretion of this metabolite was considerable, ranging from 32% to 71%.” No significant change was detected among the control women. B 0.1 g/day of EPA+DHA from halibut oil in supplement vs. no supplement Supplement includes 0.26 g ferrous iron; 0.26 g calcium; minute quantities of iodine, manganese and copper; 0.60 g thiamin/g; 0.10 g vitamin C; 0.36 g halibut liver oil In primiparae, the OR for preeclampsia was significant when comparing the treatment to the control group (OR=0.689, 95% CI 0.50-0.95). In primiparae, the OR for albuminuria was statistically significant when comparing the treatment to the control group (OR=0.717, 95% CI 0.54-0.96). In primiparae, the OR for hypertension was not significant when comparing the treatment to the control group (OR=0.862, 95% CI 0.73-1.02). In multiparae, these statistics were OR=0.677 (95% CI 0.43-1.07), OR=0.675 (95% CI 0.44-1.04), and OR=1.121 (95% CI 0.89-1.42). There were no significant effects on the occurrences of stillbirths, early neonatal deaths (before 8 days), perinatal deaths, sepsis, or the duration of labor. B

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Seafood Choices: Balancing Benefits and Risks Author Study Type Subjects Exposure Timing of Exposure Clausen et al., 2001 Cohort Pregnant women (n=3133) Mean age 29.8 years 51.8% nulliparous Representing all socioeconomic classes Aker University Hospital, Oslo, Norway No pregestational diabetes or twin/triplet pregnancies Fatty acids from food 17-19 weeks gestation until after delivery

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Seafood Choices: Balancing Benefits and Risks Amount Results Conclusion* Tertiles of saturated fatty acids (%energy) Mean = ≤12.0, 12.0-15.0, >15.0 Tertiles of monounsaturated fatty acids (%energy) Mean = ≤10.5, 10.5-13.0, >13.0 Tertiles of polyunsaturated fatty acids (%energy) Mean = ≤5.2, 5.2-7.5, >7.5 Tertiles of omega-3 fatty acids (%energy) Mean = ≤0.9, 0.9-1.6, >1.6 Tertiles of omega-6 fatty acids (%energy) Mean = ≤3.8, 3.8-5.8, >5.8 After adjusting for energy, age, smoking, BMI, systolic blood pressure for 20 weeks’ gestation, nullipara and energy: Statistically significant ORs for preeclampsia, comparing the highest group to the lowest group of fatty acid intakes, were observed for polyunsaturated fatty acids (p=0.01) and omega-6 fatty acids (p=0.05); and Statistically nonsignificant ORs for preeclampsia, comparing the highest group to the lowest group of fatty acid intakes, were observed for saturated fat (p=0.10), monounsaturated fat (p=0.59), and omega-3 fatty acids (p=0.06). N

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Seafood Choices: Balancing Benefits and Risks Author Study Type Subjects Exposure Timing of Exposure Velzing-Aarts et al., 1999 Case-control Cases (n=27) = preeclamptic women Controls (n=24) = normotensive, nonproteinuric women Pregnant women Mean age about 27 years Curacao Fatty acid composition in maternal and umbilical platelets and umbilical arteries and veins During delivery or within 2 hours after birth

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Seafood Choices: Balancing Benefits and Risks Amount Results Conclusion* Mean fatty acid composition in maternal platelets (in mol%): Controls = 9.66±2.75 LA; 0.27±0.10 ALA; 0.29±0.14 EPA; 2.03±0.62 DHA Cases = 7.0±21.91 LA; 0.22±0.11 ALA; 0.21±0.07 EPA; 2.16±0.93 DHA Mean fatty acid composition in umbilical cord platelets (in mol%): Controls = 3.73±0.76 LA; 0.14±0.10 ALA; 0.16±0.07 EPA; 2.33±0.58 DHA Cases = 4.16±1.51 LA; 0.21±0.11 ALA; 0.17±0.07 EPA; 1.97±0.30 DHA Mean fatty acid composition in umbilical veins (in mol%): Controls = 2.69±0.44 LA; 0.10±0.05 ALA; 0.09±0.04 EPA; 4.26±0.85 DHA Cases = 2.89±0.56 LA; 0.11±0.05 ALA; 0.07±0.02 EPA; 3.35±0.96 DHA Mean fatty acid composition in umbilical arteries (in mol%): Controls = 1.87±0.39 LA; 0.10±0.04 ALA; 0.09±0.03 EPA; 4.83±0.76 DHA Cases = 1.74±0.75 LA; 0.10±0.06 ALA; 0.06±0.03 EPA; 3.73±1.03 DHA “Newborns of preeclamptic women had significantly lower birth weights and gestational ages at delivery,” compared to newborns of non-preeclamptic women. Preeclamptic women had significantly lower maternal platelet levels of LA (p<0.001) and EPA (p<0.05) compared to normotensive women. Preeclamptic women had significantly lower umbilical arteries levels of EPA (p<0.01) and DHA (p<0.001) compared to normotensive women. No other significant differences were found for LA, ALA, EPA, or DHA. B

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Seafood Choices: Balancing Benefits and Risks Recommendations for Seafood and EPA/DHAConsumption TABLE B-3 Recommendations for Seafood and EPA/DHA Consumption Organization Audience Purpose of Recommendtion American Heart Association Healthy adults (without documented coronary heart disease) Reduce cardiovascular disease by dietary and lifestyle facts among the general population American Heart Association People with documented heart disease Secondary prevention American Heart Association People with elevated triglycerides Lower triglycerides Dietary Guidelines Advisory Committee Unspecified Provide sound and current dietary guidelines to consumers MyPyramid Americans Help Americans make healthy food choices, given their sex, age, and activity level National Cholesterol Education Program, National Heart, Lung, and Blood Institute People with high LDL-cholesterol/those adopting therapeutic lifestyle changes (TLC) Healthy lifestyle recommendation for a healthy heart American Diabetes Association Unspecified Lower risk of diabetes, and protect your heart and blood vessels World Health Organization Unspecified To protect against coronary heart disease and ischaemic stroke European Society of Cardiology General population To offer advice on food choices to compose a diet associated with the lowest risk of cardiovascular disease United Kingdom Scientific Advisory Committee on Nutrition General population and pregnant women To reduce risk of cardiovascular disease European Food Safety Authority Unspecified Reach daily intake for LC n-3 PUFA recommended for potential benefits to health National Heart Foundation of Australia People with coronary heart disease Preventing cardiovascular events

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Seafood Choices: Balancing Benefits and Risks Recommendations Type of Fish/Seafood Serving size # of Servings All fish, particularly fatty fish (salmon, albacore tuna, mackerel, lake trout, herring, and sardines) 3 ounces cooked (or 4 ounces raw) Two per week EPA+DHA per day, preferably from fatty fish; supplements can be considered with physician consultation 1 gram EPA+DHA One per day EPA+DHA per day as a capsule with physician consultation 2-4 grams EPA+DHA One per day Fish, especially salmon, trout, white (albacore or bluefin) tuna, mackerel, or other fish that are high in EPA and DHA 4 ounces Two per week Fish rich in omega-3 fatty acids, such as salmon, trout, and herring Not specified More often Fish, type unspecified ≤5 ounces One per day Fish Not specified 2–3 per week Fish, type unspecified Equivalent to 200–500 mg of EPA+DHA 1–2 per week Fish, particularly oily fish Not specified Consumption encouraged Fish Not specified Two per week, one of which should be oil fish (≈450 mg/ day of LCPUFA) Fish, especially fatty fish 130 grams 1–2 per week Fish, preferably oily fish Unspecified At least 2 per week

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Seafood Choices: Balancing Benefits and Risks FDA and EPA Safety Levels in Regulations and Guidance TABLE B-4 FDA and US EPA Safety Levels in Regulations and Guidance Product Level Reference Ready-to-eat fishery products (minimal cooking by consumer) Enterotoxigenic Escherichia coli (ETEC)—1 × 103 ETEC/gram, LT or ST positive. Compliance Program 7303.842 Ready-to-eat fishery products (minimal cooking by consumer) Listeria monocytogenes—presence of organism. Compliance Program 7303.842 All fish Salmonella species—presence of organism. Sec 555.300 Compliance Policy Guide All fish Staphylococcus aureus—positive for staphylococcal enterotoxin, or Staphylococcus aureus level is equal to or greater than 104/gram (MPN). Compliance Program 7303.842 Ready-to-eat fishery products (minimal cooking by consumer) Vibrio cholerae—presence of toxigenic 01 or non-01. Compliance Program 7303.842 Ready-to-eat fishery products (minimal cooking by consumer) Vibrio parahaemolyticus—levels equal to or greater than 1 × 104/gram (Kanagawa positive or negative). Compliance Program 7303.842 Ready-to-eat fishery products (minimal cooking by consumer) Vibrio vulnificus—presence of pathogenic organism. Compliance Program 7303.842 All fish Clostridium botulinum— Presence of viable spores or vegetative cells in products that will support their growth, or Presence of toxin. Compliance Program 7303.842 Clams and oysters, fresh or frozen—imports Microbiological— E. coli—MPN of 230/100 grams (average of subs or 3 or more of 5 subs); APC—500,000/gram (average of subs or 3 or more of 5 subs). Sec 560.600 Compliance Policy Guide

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Seafood Choices: Balancing Benefits and Risks Product Level Reference Clams, oysters, and mussels, fresh or frozen—domestic Microbiological— E. coli or fecal coliform—1 or more of 5 subs exceeding MPN of 330/100 grams or 2 or more exceeding 230/100 grams; APC—1 or more of 5 subs exceeding 1,500,000/gram or 2 or more exceeding 500,000/gram. Compliance Program 7303.842 Salt-cured, air-dried uneviscerated fish Not permitted in commerce (Note: small fish exemption). Sec 540.650 Compliance Policy Guide Tuna, mahi mahi, and related fish Histamine—500 ppm based on toxicity. 50 ppm defect action level, because histamine is generally not uniformly distributed in a decomposed fish. Therefore, 50 ppm is found in one section, there is the possibility that other units may exceed 500 ppm. Sec 540.525 Compliance Policy Guide All fish Polychlorinated Biphenyls (PCBs)—2 ppm (edible portion).a 21 CFR 109.30 Fin fish and shellfish Aldrin and dieldrin—0.3 ppm (edible portion). Sec 575.100 Compliance Policy Guide Frog legs Benzene hexachloride—0.3 ppm (edible portion). Sec 575.100 Compliance Policy Guide All fish Chlordane—0.3 ppm (edible portion). Sec 575.100 Compliance Policy Guide All fish Chlordecone—0.4 ppm crabmeat and 0.3 ppm in other fish (edible portion). Sec 575.100 Compliance Policy Guide All fish DDT, TDE, and DDE—5 ppm (edible portion). Sec 575.100 Compliance Policy Guide All fish Heptachlor and heptachlor epoxide—0.3 ppm (edible portion). Sec 575.100 Compliance Policy Guide All fish Mirex—0.1 ppm (edible portion). Sec 575.100 Compliance Policy Guide All fish Diquat—0.1 ppm.a 40 CFR 180.226

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Seafood Choices: Balancing Benefits and Risks Product Level Reference Fin fish and crayfish Fluridone—0.5 ppm.a 40 CFR 180.420 Fin fish Glyphosate—0.25 ppm.a 40 CFR 180.364 Shellfish Glyphosate—3 ppm.a 40 CFR 180.364 Fin fish Simazine—12 ppm.a 40 CFR 180.213a All fish 2,4-D—1 ppm.a 40 CFR 180.142 Salmonids, catfish, and lobster Oxytetracycline—2 ppm. 21 CFR 556.500 All fish Sulfamerazine—no residue permitted. 21 CFR 556.660 Salmonids and catfish Sulfadimethoxine/ormetoprim combination—0.1 ppm. 21 CFR 556.640 All fish Unsanctioned drugsb—no residue permitted. Sec 615.200 Compliance Policy Guide Crustacea Toxic elements: 76 ppm arsenic; 3 ppm cadmium; 12 ppm chromium; 1.5 ppm lead; 70 ppm nickel. FDA Guidance Documents Clams, oysters, and mussels Toxic elements: 86 ppm arsenic; 4 ppm cadmium; 13 ppm chromium; 1.7 ppm lead; 80 ppm nickel. FDA Guidance Documents All fish Methyl mercury—1 ppm.c Sec 540.600 Compliance Policy Guide All fish Paralytic shellfish poison—0.8 ppm (80 µg/100 g) saxitoxin equivalent. Sec 540.250 Compliance Policy Guide, and Compliance Program 7303.842 Clams, mussels and oysters, fresh, frozen or canned Neurotoxic shellfish poison—0.8 ppm (20 mouse units/100 grams) brevetoxin-2 equivalent. National Shellfish Sanitation Program Manual of Operations All fish Amnesic shellfish poison—20 ppm domoic acid, except in the viscera of dungeness crab, where 30 ppm is permitted. Compliance Program 7303.842 All fish Hard or sharp foreign object—generally 0.3 (7 mm) to 1.0 (25 mm) in length. Sec 555.425 Compliance Policy Guide aThese values are tolerances; bSanctioned drugs are approved drugs and drugs used under an INAD; cThe term “fish” refers to fresh or saltwater fin fish, crustaceans, other forms of aquatic animal life other than birds or mammals, and all mollusks, as defined in 21 CFR 123.3(d) (FDA, 2005c). SOURCE: CFSAN, 2001.