Understanding

International Standards for

Residues

Kevin Smith

U.S. Meat Export Federation

Technical Barriers To Trade

0%

5%

10%

15%

20%

25%

30%

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

Av

era

ge

Ta

riff

ra

te

0

50

100

150

200

250

300

350

400

450

500

Nu

mb

er

of

AD

Me

as

ure

s in

Pla

ce

Avg. Tariffs

Measures in Force

Source: Cato Institute

SPS Trade Concerns by Subject- last 10 years -

Other

Concerns

4%

Food

Safety

27%

Animal

Health &

Zoonoses

40%

Plant

Health

29%

Source: WTO

Trade Concerns Reported Solved After 10

Years

Partially

Solved

7%

Not

Solved

66%

Solved

27%

Source: WTO

Countries represent 40% of global beef eating population

Hormone Bans in 2008

Food Safety Challenges Internationally

• Differences in Standards– What constitutes a risk?

• Differences in Methodologies– How is the risk measured?

• Differences in Philosophies– What is the best way to manage the risk?

– What is the best way to communicate risk?

• What/who is influencing these decisions internationally?

• What can the U.S. do to address these issues?

What is the Next Big Issue?

• Residues

– Veterinary Drugs

– Agricultural Chemicals

• Pesticides

• Herbicides

– Growth Promoting Agents

• Beta Agonists

– Environmental Contaminants

• Heavy Metals

• Carcinogens

– Dioxin

Why?

Region ADIPartitioning of

ADI

Statistical

Calculation of

WDP

Injection Site

USNOEL X 60 kg

/ SF

Milk + eggs +

target tissue99/95

10 X muscle

Safe Conc.

(500 g)

JECFANOEL X 60 kg

/ SF

Milk + eggs + all

tissues95/95 NA

EUNOEL X 60 kg

/ SF

Milk + eggs + all

tissues95/95

Same as

muscle MRL

(500 g)

JapanNOEL X 60 kg

/ SF

Milk + eggs + all

tissues in all

species

99/95

Same as

muscle MRL

(100 g)

Source: John Nappier, Pfizer Animal Health

U.S. Animal Health Association Meeting; Reno, NV 10/23/07

Comparison of MRLs

Comparison of Regulatory Requirements

Muscle Liver Kidney Fat Milk0

100

200

300

400

500US Tolerance

EU/Japan/JECFA MRL

Edible Tissues

All

ow

ab

le C

on

cen

trati

on

,

g/k

g

Source: John Nappier, Pfizer Animal Health

U.S. Animal Health Association Meeting; Reno, NV 10/23/07

South Korea

Product Scientific Name Korea U.S. Codex

Gentamicin 0.1 NR 0.1

Neomycin 0.5 1.2 0.5

Novobiocin 1 1

Monensin 0.05 0.05

Bacitracin 0.5 0.5

Salinomycin 0 NL

Dihydrostreptomycin/Streptomyci

n 0.5 0.5 0.6

Spiramycin 0.2 NL 0.2

Amoxicillin 0.01 0.01

Ampicillin 0.01 0.01

Erythromycin 0.1 0.01

Oxytetracycline 0.1 2

Chloramphenicol 0 0

Chlortetracycline 0.1 2 0.2

Tetracycline 0.25 2

Tylosin 0.2 0.2

Benzylpenicillin/Procaine

benzylpenicillin 0.05 NL 0.05

Product Active

Ingre.

U.S. Wthdr. Rec.

Wthdr. (JP)

Company

ChlorMax®

50

Chlortetrac

ycline

0 days 10 days Alpharma

Chloratet

50

Chlortetrac

ycline

0 days 10 days ADMAH

Dectomax

® inject

Doramectin 24 days 60 days Pfizer

Benzathine

Penicillin

inject

Benzathine

Penicillin

50 days FARAD

Draxxin®

inject

Tulathromy

cin

5 days 33 days Pfizer

Packer Perspective

• “Most Stringent Common Denominator”

– Simplify the process

• Risk or Cost of Failure

– Who gets the blame and the bad publicity?

• Needs flow upstream to Producers

How Can We Manage These

Issues?

• Communication

– Producer Level

– Packer/Processor Level

– Animal Health Companies

– U.S. Government

• Work towards Consistency

– Address issues with

International Standards

0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

mt

Beef Fish Pork Poultry

U.S. Meat Consumption

1961-2001

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

7,000,000

8,000,000

9,000,000

mt

Beef Fish Pork Poultry

Japan Meat Consumption

1961-2001

Questions?