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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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.
Representative terms from entire chapter:
fish consumption
