Stakeholders Forum Dioxin in FoodFeed US FDA Sampling

							Dioxin in Food/Feed: US FDA sampling
Richard Canady Paul South US Food and Drug Administration

Documents of interest for FDA
2001 JECFA dioxin assessment 2003 NAS dioxin in food supply report EPA assessment in response to 2006 NAS review of the 2003 draft EPA dioxin re-assessment Draft CODEX code of practice

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Concepts to consider in addressing dioxin in food
Hazard assessment supports action Period of intake relevant to toxicity is long
Clipping highs is ineffective for risk reduction

Effect of regulatory limits is uncertain Broad, diffuse sources for dioxins High cost of monitoring

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Hazard and risk
EPA, SCF, WHO, JECFA assessments agree
– Exposures are in a range we don’t like to see, considering the relative-risk they indicate. – There is a basis for considering further action.

The question is do we know what actions will improve health?
– Which actions with regard to food levels will effectively and equitably reduce exposure? – What is the net risk change for risk management choices?

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Table 3-28. Background CDD/CDF TEQs in Fish and Shellfish, Consumption Rates, and Intakes
Consumption Rate (g/day) 0.58 0.043 0.042 0.034 0.88 0.9 0.41 0.17 0.14 0.035 0.00083 0.01387 CDD/CDF TEQ Conc. (Pg/g fresh wt.) 1.8 1.2 0.57 0.068 1.3 2.0 1.9 1.2 1.2 0.49 0.57 1.3 CDD/CDF TEQ Intake (pg/day) 1.0 0.052 0.024 0.0023 1.1 1.8 0.78 0.20 0.17 0.017 0.00047 0.018

Fish Class Estuarine Finfish Flounder (e)(f)

Species

N 3 26 39 2 0 30 6 3 4 3 39 0

Rockfish/Striped Bass (d) Salmon (d) Mullet (a) Other Flatfish, Perch, Croaker, Herring, Anchovy, Smelts, Eel, Sturgeon Total Other*

Setting levels is an almost impossible task This is just the fish.

Freshwater Finfish

Catfish-farmed (b,d,h) Trout-farmed (e,h) Perch (e) (walleye) Carp (e) Pike (e) (pickerel) Salmon (d) Other: Whitefish, Cisco,Smelts, Rainbow, Sturgeon Total Other*

Total Freshwater/Est. Finfish
Freshwater/Estuarine Shellfish Shrimp (b,c) Crab Average Oyster Average Scallop (d) Crayfish Other: Clam, Snails Total Other**

3.3
2.0 0.30 0.15 0.0011 0.0090 0.0157

116
19 33 18 11 25 0

1.6
0.08 0.60 0.57 0.16 0.74 0.43

5.2
0.16 0.18 0.086 0.00018 0.0067 0.0068

Total Freshwater/Est. Shellfish
Unknown Freshwater/Est. Species Fish***

2.5
0.14

173
0

0.18
1.3

0.44
0.18

Total Fresh./Est. Fish
Marine Finfish Tuna (c) Cod (c) Salmon (d) Pollack (d) Mackerel (a) Other: Porgy, Haddock, Whiting, Squid, Perch, Sardine, Sea Bass, Swordfish, Pompano, Octopus, Flatfish, Halibut, Snapper, Whitefish, Smelt, Shark, Roe Total Other****

5.9
3.1 1.4 1.3 0.25 0.11

289
16 18 39 19 1

1.0
0.06 0.15 0.57 0.22 0.95

5.9
0.19 0.21 0.74 0.055 0.10

1.8

0

0.39

0.7

Total Marine Finfish
Marine Shellfish Scallop (d) Lobster (d) Crab (d) Other: Clams, Mussels, Conch, Snails Total Other****

8.0
0.19 0.19 0.16 0.77

93
11 16 38 0

0.25
0.16 0.26 0.36 0.26

2.0
0.030 0.049 0.058 0.20

Total Marine Shellfish
Unknown Marine Species Seafood (g)*** Fish***

1.3
0.080 0.220

65
0 0

0.26
0.39 0.39

0.34
0.031 0.09

Total Marine Fish

9.6

158 359

0.26 0.54

2.5 8.3

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TOTAL FISH

5

15.5

Short term variation in intake is relatively unimportant
5000

1000 pg/kg dose

amount (pg / kg Bw)

4000 3000 2000 1000 0 0 20 40 60 80 100

100 pg/kg dose
Model as in Zeilmaker, M.J. and J.C.H. van Eijkeren (1998). “The calculation of human toxicity thresholds of 2,3,7,8-TCDD: A Physiologically Based PharmacoKinetic modeling approach.” RIVM report 601503.010, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.

age (year)

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FDA approach
Sampling Evaluate exposure level Follow up where sources are unusually high Good practice development
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FDA Dioxin Strategy
FDA has been concerned about DLCs and has been monitoring food and feed with the goal of identifying ways to reduce dietary exposure In July 2001, FDA developed a strategy for DLCs (www.cfsan.fda.gov/~lrd/dioxstra.html) The purpose of FDA’s Dioxin Strategy, which significantly expanded FDA’s dioxin monitoring program, is to develop the science to support appropriate risk management actions
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FDA Dioxin Program Goals
Obtain profiles of background levels of DLCs in a wide variety of food and feed Identify opportunities for DLC reduction by eliminating or reducing contamination sources Provide estimates of dietary DLC exposure

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FDA Sample Request Summary
Year 2001 2002 2003 2004 2005 2006
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TDS 270 214 232 232 232 232

Targeted ~500 ~1,000 ~1,400 ~1,400 ~1,400 ~850
10

Total ~800 ~1,300 ~1,600 ~1,600 ~1,600 ~1,100

FDA Targeted Sampling
Milk/Dairy Products Eggs Fish, wild/farmed (retail/grower) Fats/Oils Grains/Cereals Fruits/Vegetables Tree Nuts/Peanuts Fat Soluble Vitamins Feed/Feed Components Follow-up Sampling
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FDA Follow-up Investigation
CFSAN monitoring program identified aquaculture fish/feed samples with elevated PCDD/PCDF CFSAN/CVM issued investigation at feed mill finding elevated PCDD/PCDF in mineral premix CVM issued investigation at premix manufacturer and mineral supplier identifying a zinc oxide with elevated PCDD/PCDF Recall of mineral premix/feed containing the contaminated zinc oxide was implemented (www.fda.gov/cvm/CVM_Updates/zincdioxin.htm)

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Aquaculture Feed/Fish (FY02)
1.8 1.6
Dioxin TEQdf (pg/g)
w/ contam ZnO w/o contam ZnO

1.4 1.2 1 0.8 0.6 0.4 0.2 0 Feed

Aquaculture Fish

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Relative TEQ Contribution in Fish, Feed, and Contaminated Zinc Oxide

F D pC F H D 9F C 8, D O 7, pC 4, H 3, 82, 7, 1, 6, DF 4, C 3, Hx 2, 91, 8, DF C 7, 3, Hx 2, 81, 7, DF 6, C 4, Hx 3, 82, 7, DF C 6, 3, Hx 2, 81, 7, 4, DF 3, C 2, Pe 1, 87, DF 4, C 3, Pe 2, 87, 3, F 2, D 1, TC 87, D 3, D 2, pC D H D 8C 7, O 6, DD C 4, 3, Hx 2, 91, 8, DD 7, C 3, Hx 2, 81, 7, DD C 6, 3, Hx 2, 81, 7, 4, DD 3, C 2, Pe 1, 87, 3, D D 2, 1, TC 87,

Feed ZnO

Fish

3, 2,

0.8

0.6

0.4

0.2

1

0

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Relative TEQ Contribution

FDA’s Total Diet Study
TDS is FDA’s ongoing market basket survey of approximately 280 foods in U.S. food supply FDA’s TDS determines levels of various pesticide residues, contaminants and nutrients in table-ready foods In 1999, FDA began analyzing TDS foods for PCDD/PCDFs (3 DL-PCBs added in 2004)
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TDS Food Results
TDS Food Whole Milk American Cheese Ground Beef, pan cooked White Bread Butter Bologna Apple Juice Scrambled Eggs
*Values are mean WHO-TEQDF for 2001-2004 TDS foods.

Mean WHO-TEQDF* (pg/g food, ND=0) 0.010 0.033 0.126 0.001 0.198 0.130 0.000 0.027

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In f

pg WHO-TEQDF/kg bw/month

60 50 40 30 20 10 0

PCDD/PCDF Exposure Estimates from 2001-2004 TDS Foods

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ND=0 ND=LOD ND=1/2LOD

From: www.cfsan.fda.gov/~lrd/dioxee.html

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T an ota ts l U 6- S 1 C 1 m P op hi o Ch ld 2 nth ild ye s Ch a ild 6 y rs 10 e ar G ye s ir a ls rs Bo 14 W ys -1 om 14 6 en -16 M 2 W en 5-3 om 2 0 e n 5-3 M 40 0 W en -4 om 4 5 e n 0-4 M 60 5 e W n 6 65 o m 0e n 65 M 70 en + 70 +

2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0
pg WHO-TEQDF/kg bw/day

Targeted (Non-TDS) Food Samples
CFSAN will be posting PCDD/PCDF data for targeted (non-TDS) foods including additional exposure estimates from this data

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Codex/Dioxin Code of Practice
CFSAN heads U.S. delegation to Codex Committee on Contaminants in Food CFSAN has worked with other countries to develop international code of practice titled “Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-Like PCB Contamination in Food and Feed” Code of Practice recently adopted by Codex Alimentarius Commission (July 2006) Available at: www.codexalimentarius.net (ALINORM 6/29/12, Appendix XXVI)

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NAS “dioxin in food” report recommendations (July 2003)
Limited win/win situations Data limitations Resource bottleneck

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NAS - Win/Win Overlap with general dietary issues
Promote changes on food availability that realize overlap with other issues
– Sat fat. Obesity. Eat your veggies.

Behavioral research
– Dietary guidelines would reduce both dioxin and CHD/obesity if more people followed them – Research needed to find keys to changing behavior

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NAS - Data limitations

Don’t know enough about how dioxin enters the feed supply to make recommendations on how to control

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NAS - Fix the resource bottleneck
Make methods cheaper (and get data) before deciding what to do Develop infrastructure to make it work for you where you can (develop good practices that alter use of and demand for higher dioxin sources/practices) Pool data, collaborate for change

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NAS recommendation on levels
No levels now, given the knowledge base (and the cost of analysis)

“consider setting legally binding limits on DLCs in forage and feed only when more complete data are generated and a better understanding is developed of how DLC contamination can be avoided.”
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NAS dioxin 2006
Not much for FDA directly, of course Recommendation to set an RfD may overlap with JECFA assessment Recommends that EPA develop a data base on food levels with congener-specific information in order to make exposure estimates more transparent
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USG coordination on dioxin
National Science and Technology Council IWG for dioxin Ad hoc interagency working group on food and feed sampling and follow-up
– USDA, EPA, FDA, CDC – Currently quiescent

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Next steps
Exposure estimates that include
– Dioxin like PCBs – Sampling beyond the “Total Diet Study”

Data release Working with EPA in the NSTC IWG setting
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