International Implications of Animal Health Products on

Meat Safety and Quality

Paul ClaytonU.S. Meat Export Federation

Animal Health CommitmentsVeterinarians agree to protect animaland public health when they pledgethe Veterinarian’s Oath. This oath isas applicable today as it was when itwas written many years ago. Swinepractitioners are committed to "theuse of scientific knowledge and skillsfor the benefit of society". Thiscommitment remains the core ofveterinarians’ efforts to achieve "theprotection of animal health, the reliefof animal suffering, the conservationof livestock resources, the promotionof public health, and theadvancement of medical knowledge."

NBP 2000 Pork Safety Fact Sheet

Advancements in animal production practices mean that cattle can be raised much more effectively than in the past. Producers’ time-honored traditions of animal care and stewardship always are expanding to include the most recent scientific advancements that keep cattle healthy and the beef supply safe.

NCBA 2009 Beef Fact Sheet

Value of Productivity Gains

Elam and Preston, 2004 Fifty Years of Pharmaceutical Technology and its Impact on the Beef we Provide to Consumers

Conclusions• Through a combination of research, technology

development and innovation, the US beef cattle industry has increased the productivity of its herd by over 80% in the past 50 years.

• None of the technologies account of the increases in overall productivity; it is a combination of improved genetics, feeding practices, animal health products, management efficiencies and many other factors.

• The increase in beef industry productively has been a dramatic reduction in the overall environmental impact of the industry.

• The primary benefits of increase productivity have accrued to the cattle industry and its US beef consumers. In 2004 we had a more plentiful, less expensive and higher quality beef supply than we did in 1955.

Elam and Preston, 2004 Fifty Years of Pharmaceutical Technology and its Impact on the Beef we Provide to Consumers

International Criteria of Animal Health Compounds• Approval by a Country’s Health

Agency

– Intellectual Property Concerns• Illegal Manufacturing

– Domestic and Import Monitoring• Sampling and Analytical

Procedures• MRL Standards• Sanctions

– Current Import Testing Programs

• Japan, Russia, Korea, Canada, EU, China, Taiwan and Mexico

– WTO Notices on New or Enhanced Programs

• Japan, Taiwan, China and Vietnam

International Use of Animal Health Compounds• Animal Health Products and

Growth Promotants– Developed Agricultural

Countries• Frequent Use• Regulatory and

Management Programs for Domestic and Export Consumption

– EU Criteria– Under Developed Countries

• Frequent Use, Limited Animal Care Capabilities

• Minimal Regulations• Illegal Manufacturing and

Use

Increased Awareness to Animal Health Products and Growth Promotants

• Melamine: Pet Food, Baby Formula, Tooth Paste, Animal Feeds etc.– Increased Testing for

Pesticides in Plant Based Foods

• Codex Standards for Residues in Food– USDA Comparison Data

Base• http://www.mrldatabase.com

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?

Primary Philosophical Differences

• U.S. Food Safety Objectives- Process Control– Identify and manage food borne risks– Develop and administrate procedures to

minimize risks– Use verification procedures to measure the risk

reduction • Alternative Objective- Command and Control

– Set standards– Test– Sanction

• Precautionary Principle versus substantial equivalency

Residues• Not a Mutual

Understanding or Agreement on Animal Health Product Risks

– US HACCP– Animal Health Product Residues “Hazard NOT Likely to Occur”

– USDA FSIS National Residue Program, Based on FDA Approval

Scientific Community

USDA ARSUniversitiesPrivateNCBANPB

RegulatorsUSDA APHISUSDA FSISFDAEPA

IndustryProductionProcessingDistributionRetailFood Service

Consumer

CDC Sentinal SiteEpidemiological Data Baseon Food Borne Illness

Procedures for sampling, analysis and risk assessment

U.S. Food Safety Management Systems

Why is There a Difference in MRLS?

Region ADI Partitioning of ADI

Statistical Calculation of

WDP

Injection Site

US/FDA NOEL X 60 kg / SF

Milk + eggs + target tissue 99/95

10 X muscle Safe Conc.

(500 g)JECFA/CODEX

NOEL X 60 kg / SF

Milk + eggs + all tissues 95/95 NA

EU / EFSA NOEL X 60 kg / SF

Milk + eggs + all tissues 95/95

Same as muscle MRL

(500 g)

Japan / MHLW

NOEL X 60 kg / SF

Milk + eggs + all tissues in all species

99/95Same as

muscle MRL (100 g)

Source: John Nappier, Pfizer Animal Health

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

South KoreaProduct 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/Streptomycin 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

Japan Example

• Sept 2001 : 1st BSE case was reported

• April 2002 : BSE investigation committee submitted the Report for root cause of BSE outbreak and food safety procedure from now. In this report, it was recommended to regulate animal drugs and feed additive with the same standard and to establish MRL based residue control

Product Active Ingredient

U.S. Withdrawal

Recommended Withdrawal (Japan)

Company

ChlorMax® 50 Chlortetracycline 0 days 10 days Alpharma

Chloratet 50 Chlortetracycline 0 days 10 days ADMAH

Dectomax®inject

Doramectin 24 days 60 days Pfizer

Benzathine Penicillin inject

Benzathine Penicillin

50 days FARAD

Draxxin® inject Tulathromycin 5 days 33 days Pfizer

How Can We Manage These Issues?• Information

– USDA Databasehttp://www.mrldatabase.com

– National Pork Board Japan MRL Data Base• http://www.pork.org/Producers/JapanMRL.

aspx• Communication

– Producer Level– Packer/Processor Level– Animal Health Companies– U.S. Government

• Work Towards Consistency and Equivalency

Consumer Concerns

• Long Term Health Effects due to Chemical Residues in Foods (Cancer)

• Short Term Health Effects due to Food Poisoning (Microbiology)

• Top Line Consumer Concern– Concerned about the use of antibiotics and

hormones in meat production– Aware of the use of antibiotic and hormones

in meat production

Media Report• According to Health Bureau of Guangzhou of Guangdong

Province today, starting from Feb. 18 to 19, the hospitals of city of Guangzhou have accepted and treated abut 46 patients who got poisoned by eating pork offal products fed with clenbuterol. By today these patients have recovered and were discharged from hospitals.

• The reports were on Chinese websites saying that the symptoms for these patients after eating pork variety products were: both their hands and feet were shaking, panic and feeling that they also had a fever, some patients were feeling their hearts were beating faster, etc. Then the websites quoted as saying that various countries have different regulations for clenbuterol

• In China it is forbidden; in EU it is forbidden; in the U.S. paylean is 50ppb (MRL); Canada: MRL for paylean: 40ppb.

• It is easy to see in this example that the media have reported that something making people sick in China is allowed in the U.S. and Canada!

• WE BELIEVE production practices affect consumer acceptance of beef.•WE BELIEVE the BQA Program has and must continue to empower beef producers to improve the safety and wholesomeness of beef.•WE BELIEVE these fundamental principles are the fabric of the BQA Program.

Empowering people…because producers can make a difference.Taking responsibility…because it’s our job, not someone else’s.Working together…because product safety and wholesomeness is everyone’s business.

Growth Promotants• Major contributor to improved

efficiencies, greater product yield and more value for the consumer.

• Very difficult to measure residues of hormones – FDA Regulation; amount above a normal

occurring level• Several Counties have Hormone Bans

– EU Influences– Japan – Ractopamine Import MRL

Countries represent 40% of global beef eating population

Hormone Bans in 2009

EU Additional Residue Tests

• Number of Compounds Tested has Been Reduced Over the Past 10 Years– Compounds Banned in US– Some Compounds in the USDA FSIS NRP

• Compounds Added– Paylean / Opti-Flex– Zilmax

BEEF PORK1999 2004 2009 1999 2004 2009

Stilbenes DES / Hexestro / Dienestrol x x x x

Antithyroid Agents Thyrostats x x x x

Steriods MGA x x x

Nortestosterone x x x x

Trembolone x x x x xResorcyclic Acid Lactones Zeranol x x x x x

Taleranol x x x

Beta-Agonists Clenbuterol x x x x

Cimaterol x x

Salbutamol x x

Ractopamine x x x x

Zilpaterol xUnauthorized Compounds Nitrofurans x x x x

Nitroimidazoles x x

Chloramphenicol x x x x

Sedatives Azaperone x x

Propriopromazine x

Carazolol x

Chemical elements Cadmium / Lead x x x xTotal Compounds 13 17 6 14 20 1

Growth Promotants - Concerns• Some research has shown

that “aggressive” use of hormonal growth promotants may show an appreciable reduction in intramuscular fat deposition and decreased beef tenderness. (Roeber et. .al 1999 and Platter et. al. 2001)

• Growth promotants (specifically hormones) tend to be priority concern for consumers.

Growth Promotants Paradox• Consumers are generally price

driven. But if they are a aware or believe the product may have a harmful substance they may choose a product that provides some assurance there are no harmful substances. However, in many cases consumers may choose to take the risk of the “unknown” because of a lower price. Risk has value

Organic / Natural• International Organic Programs Based on

CODEX Standards– Growing market but small worldwide – Difficult with livestock and Meat– 20-40% higher consumer prices

• Natural does not Translate Well in Foreign Markets

• Natural Programs can be Leveraged with EU Programs – Pork for the European Union

– Non Hormone Treated Cattle

Natural Brands

Multi Drug Resistant Organisms• MDRO

– Global Antibiotic Use– EU / Denmark / Sweden Experiences– MRSA

• More Virulent Forms - health care facilities and athletic locker rooms

• Less Virulent Forms – ubiquitous – companion animals

• Less Invasive Forms – hog farms in Europe and Canada

– No evidence MRSA is spread through meat

Summary• Through science and research,

strengthen the alignment of the technical issues between pharmaceutical manufacturers, livestock production, meat processing, international trade and consumers.

• Enhance livestock and meat industry awareness of consumer concerns of animal health products

• Continue the extensive research of animal health products on meat quality and safety.

• Science must be a basis in international meat trade agreements