USDA, Food Safety and Inspection Service Food Safety and Antimicrobial Residues in Food Animals B. P. Dey. DVM, Ph.D. USDA, FSIS, AEPFS Washington, D.C

USDA, Food Safety and Inspection Service

Food Safety and Antimicrobial ResiduesFood Safety and Antimicrobial Residuesin Food Animalsin Food Animals

B. P. Dey. DVM, Ph.D.

USDA, FSIS, AEPFS

Washington, D.C. &

Edna Negron, Ph.D.

University of Puerto Rico, Mayaguez


Food Safety (Definition) Food Safety (Definition)

U.S. Department of Health and Human Services

Public Health Service

Food and Drug Administration

1999 Food Code

****************(27) "Food" means a raw, cooked, or processed edible

substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or

chewing gum.


Food Safety (Definition) Food Safety (Definition)

A suitable product which when consumed orally either by a human or an animal does not cause health risk to consumer.


How Safe is Food (Meat) How Safe is Food (Meat)

Increased Food Borne Illnesses of 1980’s

National Research Council (Food Nutrition Board)

• Scientific Basis of the USDA’s Meat and Poultry Inspection Program (Risk Assessment Approach)


Pathogen Reduction/Hazard Analysis & Pathogen Reduction/Hazard Analysis &

Critical Control Points SystemCritical Control Points System

PR/ HACCP Final Rule

(9 CFR Chapter III)

July 1996


PR/HACCP PreamblePR/HACCP Preamble

Overall Food Safety Strategy Regulatory Reform Flexibility and Encourage Industry

Involvement Farm-To-Table Approach


Pathogen Reduction/Hazard Analysis & Pathogen Reduction/Hazard Analysis &

Critical Control Points SystemCritical Control Points System 1. Standard Sanitation Operating Procedure (SSOP)

2. Pathogen Reduction

a. E.coli Testing

b. Salmonella (Performance Standard) Testing

3. Hazard Analysis Critical Control Points (HACCP)


Food Safety Hazard Food Safety Hazard

(Unsafe for Human Consumption)

Biological (Bacteria, Viruses, Protozoa, BSE (?)) Physical Chemical (Agricultural Chemicals /Animal Drugs

and Environmental Contaminants )


Food Safety Problem Food Safety Problem

Farm -To-Table Continuum Hazard at Production, Distribution or

Consumption


Concept of Farm-to-Table Food SafetyConcept of Farm-to-Table Food Safety. .

INSafe Raw Food Product for

Production

OUTSafe Processed Food Product

ResultSafe Food On Table


ChallengesChallenges

Adulteration Organoleptic Examination Farm-To-Table Strategy


Chemical ResiduesChemical Residues

Growth Promotants• Arsenicals , Antibiotics, Clenbuterol

Drugs • Antimicrobials (Antibiotics, sulfonamides,

coccidiostat, anthelmentics, carbadox, phenylbutazone , Halafuginone

Insecticide• Chlorinated Hydrocarbons and

organophosphates


Antibiotics Antibiotics

Antibiotics are chemicals substances which has the capacity to inhibit the growth of microorganism or destroy them

Bacitracin Hygromycin Streptomycin

Chlortetracycline Neomycin Tetracycline Erythromycin Novobiocin Tilmicosin Flavomycin Oxytetracycline Tylosin Gentamycin Penicillin

FSIS analyzed 7,834 Domestic monitoring & Special project

samples in 2000


SULFONAMIDESSULFONAMIDES Sulfonamides are drugs with bacteriostatic activity used as

feed additives and for treating infections.

Sulfabromomethazine Sulfaguanidine Sulfaphenazole

Sulfacetamide Sulfamerazine Sulfapyridine

Sulfachlorpyridazine Sulfamethazine Sulfaquinoxaline

Sulfadiazine Sulfamethizole Sulfasalazine

Sulfadimethoxine Sulfamethoxazole Sulfathiazole

Sulfadoxine Sulfamethoxypyridazine Sulfatroxazole

Sulfaethoxypyridazine Sulfanilamide Sulfisoxazole

FSIS analyzed 6,623 Domestic Monitoring and Special Project samples in 2000


Why Prevent Antibiotic Residue Why Prevent Antibiotic Residue in Meat?in Meat?

Immediate Effect

- Anaphylactic reaction

- AllergyDelayed Effect

-Drug resistant organism -Therapy failure

-Economics

-Impact on immune response


Why Antimicrobial Residue Why Antimicrobial Residue Occurs Occurs

1. Shot gun Therapy

2. Illegal Use

3. Excess Use

4. Improperly Prepared/labeled Feed

5. Non Observance of Drug Withdrawal time


FSIS Regulated Product & ActionFSIS Regulated Product & Action

Violative & Illegal Drugs and Chemicals Processor held Responsible for

Chemicals Processor Asking Producer to Supply th

Risk-free Raw Product


Screen Tests For Detecting Screen Tests For Detecting Antibiotics Antibiotics in Animal products in Animal products

Meat:

1. Swab Test on Premises (STOP)

2. Calf Antibiotic and Sulfonamide Test (CAST)

3. Fast Antibiotic and SulfonamideTest (FAST)

Milk: 1. Charm Test

Live Animals 1. None


Antibiotic Violations in Meat: Antibiotic Violations in Meat: 2000 FSIS Domestic Residue Plan2000 FSIS Domestic Residue Plan

Monitoring Enforcement

ProductionClass % Violations % Violations

Bulls 0.0 12

Beef cows 0.3 10

Dairy cows 1.0 19

Bob veal calves 1.9 NS Heifers 1.9 8

Steers 0.8 11

Roaster pig 3.2 NS

Market Hog 0.8 5

Sows 2.1 11 Boar /stags 1.6 NS


Sulfonamide Violations in Meat Sulfonamide Violations in Meat

Monitoring Enforcement

Production Class % Violations % Violations

Bulls 0.0 12

Beef cows 0.3 10

Dairy cows 1.0 19

Bob veal 1.9 0

Market Hog 0.8 5

Bora/Stags 1.6 NS Roaster Pig 3.2 NS

Sows 2.1 11


Rate of Residue Violations In Rate of Residue Violations In Puerto RicoPuerto Rico

Total Samples Violations/ Rate(%)

Year Cattle Calves Swine Cattle Calves Swine

1999 141 164 19 32 (23) 0 0

2000 150 147 11 43 (29) 1 (1) 0

2001 99 130 14 18 (18) 0 0

_________Total Violations : Cattle: 70 (Antibiotics-68; Sulfonamide-1;

CHC-1) Calf-1 (Antibiotics)


Approach & Concerns inApproach & Concerns in Residue ControlResidue Control

Rethinking in a HACCP

environment Sample for certain chemicals in

certain establishment Verification


Food Safety OrganizationsFood Safety Organizations

American Food Safety Institute: Training in food safety handling. Arcoplast: Contamination control training for industry.

Environmental Outcomes: Training for foodservice and hospitality industries. Food Chemical News: Newsletter for food safety regulations/legislation/ enforcement etc.

Food Safety 2000: Multimedia-based training program.

Food Safety Resources: Information & training on FDA food code.

Hi-Tech Detergents Ltd - manufacturer/designer of detergents, sanitisers, and animal remedies.


Residue Avoidance ActivityResidue Avoidance Activity

Food Safety and Inspection Service State Producer Groups Universities Industrial Organizations Consumer Group


Residue Control in HACCP Residue Control in HACCP EnvironmentEnvironment

FOLLOW NAS GUIDELINE

Frame work for control of chemical hazard Consideration of management of chemical hazard

HACCP


HACCP Compatible Production HACCP Compatible Production Practice #1 Practice #1

Keep medication record for at least 12 months following marketing of any

medicated livestock How?

-Individually -By Group -By Pen

Tool for Identification

-Sow Card -Paint -Ear Tags

-Ear Notch -Tatoo -Micro(Bio) Chips-



Maintain Medication and Production Records

1. Routine Vaccination Protocol

2. Use of Medication to prevent Disease (Shipping, Change in Weather) and Stress of Mixing

3. Use of Animal Health products in breeding herd

4. Use of feed additive in finisher unit

5. Routine Treatment Plan -



Properly Store , Labels, and Account for All Drugs Products and Medicated Feed.

Follow labels directions for storage and use Effectiveness (dose) - Storage Temperature

(refrigeration) - Administration (Route) - Precaution

- Warning (Withdrawl time to market) - Expiration Date

Inventory Control and Storage- Storage of Feed and water additives, use of syringes

- Separation of medication from Farm Chemicals

- Condition of a medicant


HACCP Compatible Production HACCP Compatible Production Practice # 4 Practice # 4

Valid Veterinarian/ Client / Patient Relationship

1. Who is responsible for making medical judgement?

2. Regular visits by a veterinarian

3. Commitment by veterinarian



Administering Medications

a. Injection

Routes (IM /SQ /IP/ IV/ IN)

Needle Usage

b. Water ( Availability of non medicated water after administration of medicated water)


HACCP Compatible Production HACCP Compatible Production Practice # 6Practice # 6

Commercial Feed processors Procedure

Feed Manufacturer

– Meet specification for nutritional composition– Meet desired medication level– Free of contamination


HACCP Compatible Production HACCP Compatible Production Practice # 7Practice # 7

On Farm Feed Processing Buildings and Grounds (House keeping, space, preventive

maintenace and storage of medicated feed) Equipment (Suitable, Capable, Cleaning, Accuracy) Work Space and Storage Area (work place and storage design,

and separation areas) Product Quality Assurance (Laboratory assay, Equipment

Cleaning) Labeling (Proper handling and storage of medications and

labels) Record Keeping( Visual inspection, Written records, Retain

records, storage of sample of finished feed for 6 months)



Drug Residue Testing When Appropriate

a. Culled Animal For Sale

b. Animal received extra label treatment

c. Roaster Pigs/ Steers

d. Exhibiting at Livestock Stock Shows and Fairs

e. Other special situations (Accidental spill/Exposure)



Establish and Implement Effective Herd Health management plan

Check for Disease Observe herd with veterinarian Perform test for disease exposure Conduct Post Mortem following diagnostic procedure Conduct Slaughter Checks Review Production record

“BIOSECURITY”



Code of Practice for Food Animal producers

Proper Facility to Protect and Shelter Animals Well Kept facility to allow Safe, Humane and efficient

Movement of Animals Trained personnel to take proper care of animals Provide clean water and nutritionally balanced feed Follow herd health program with Veterinarian advice Provide prompt veterinary care Humane method for euthanasia

Safe movement/ transportation of animals


Support and promote the FSIS effort to

create an environment for Farm-to-Table Food Safety Concept.

ConclusionConclusion


ReferencesReferences PR/ HACCP Final Rule,(9 CFR Chapter III) July 1996. Residue Control in a HACCP Environment. Federal Register. 5(229): 70809-

70815 , Nov 28, 2000. Quality Assurance -A Program for Pork Producers,Level iii, National Pork Board,

1997. USDA, FSIS, Domestic Residue Data Book, National Residue Program 2000. Farm to Fork: Critical Control Points for Food Safety, J. Nutrition & Menu

Development, Vol. 3(2), 2001 Milk and Dairy Beef Quality Assurance Program: Milk and Dairy Beef Residue

Prevention Protocol -1996 Producer Manual Human Heal Impact and Regulatory Issues Involving Antimicrobial Resistance in

Food Production Environment. Regulatory Research Perspectives. Vol. 1, Issue 1, July 2001

Documents

USDA, Food Safety and Inspection Service Food Safety and Antimicrobial Residues in Food Animals B. P. Dey. DVM, Ph.D. USDA, FSIS, AEPFS Washington, D.C