Food Safety and Inspection Service NATIONAL RESIDUE PROGRAM (NRP)

NRP

presented by •

Dr. Manzoor Chaudry

•

Dr. Jim Kile

NATIONAL RESIDUE PROGRAM NRP

• • • Prevention of illegal chemical residues in the food supply is an integral aspect of maintaining a high level of food safety.

Is a multi-component analytical testing program for chemical residues in domestic and imported products.

Provides a number of sampling plans to VERIFY that slaughter establishments and foreign inspection systems are fulfilling their responsibilities under HACCP for preventing violative residues.

NATIONAL RESIDUE PROGRAM (Continued)

• The NRP is designed to provide: – A structured process for identifying and evaluating compounds – The capability to analyze for compounds of concern – Appropriate regulatory follow-up of reports of violative tissue residues – Collection, statistical analysis, and reporting of the results of these activities

NATIONAL RESIDUE PROGRAM NRP

• • • • • Goals include: Enforcement of Federal laws and regulations Act as a deterrent against the slaughter of adulterated animals and the processing of adulterated eggs Maintain consumer confidence by ensuring that meat, poultry and egg products are not adulterated Assess and communicate human exposure to chemical residues Provide verification of residue control in HACCP systems

REGULATORY RESPONSIBILITY

• • • •

Food Safety and Inspection Service (FSIS)

: Testing and coordinating the efforts of the regulatory agencies to control residues in meat, poultry, and egg products.

Food and Drug Administration (FDA)

: Approval of drug and feed additive usage's; and establishment of drug tolerances in meat, poultry, and egg products, and their enforcement.

Environmental Protection Agency (EPA)

: Approval of pesticides and establishment of their tolerances in meat, poultry, and egg products.

Meat Industry

: Reduce or eliminate residues in meat, poultry, and egg products.

NATIONAL RESIDUE PROGRAM NRP

Potential food safety hazards related to • • • residues include: Animal drugs Pesticides Environmental contaminants

NATIONAL RESIDUE PROGRAM DESIGN

• • Revised on an annual basis Compounds are ranked according to public health risk • Includes approved and unapproved compounds in the monitoring program

NATIONAL RESIDUE PROGRAM (Components)

• • • • • Domestic Residue Sampling Program Import Residue Sampling Program EU Additional Testing Investigational New Animal Drugs (INAD) Biologics

DOMESTIC RESIDUE SAMPLING PROGRAM (Components)

• Monitoring Plan – Domestic & Imported Product • • • Special Projects Surveillance Sampling Enforcement Testing – In-Plant • Contamination Response System (CRS)

SAMPLING SUMMARY TABLES Source: 1999 & 2000 FSIS National Residue Program 1999

• • • Monitoring Plan Special Projects Import (Port of Entry)

32,280 5,800 8,688

TOTAL

2000 37,480 2,770 7,395 46,751 47,645

MONITORING PLAN

Sampling of specified animal populations to provide information about the occurrence of residue violations on an annual, national basis – statistically based random selection – from animals that appear normal and healthy at the time of slaughter – from animals that have passed inspection

MONITORING PLAN (Continued)

• • • Sample Request Forms Generation – Headquarters Distribution – Federally Inspected Plants – Importing Establishments – State Inspected Plants

COMPOUNDS in 2000 NRP

• Monitoring Plan: Arsenicals Avermectins Beta Agonists Sulfonamides Antibiotics Flouroquinolones Carbadox Tilmicosin Tranquilizers CHC/COP Others

SPECIAL PROJECTS

• Information gathering studies: – will not be conducted over a full 12-month period – used to develop information on frequency and concentration at which residues occur – from animals that appear normal and healthy at the time of slaughter – from animals that have passed inspection

SPECIAL PROJECTS

(Example) • Clenbuterol testing – coordinate testing with the States that conduct animal fairs – monitor testing by FSIS in plants slaughtering show animals • Other projects – coordinate within FSIS and states – phenylbutazone, flunixin

SURVEILLANCE SAMPLING

• • Are information gathering studies Is designed to: – distinguish components of a production class in which residue problems may exist – measure the extent of the problem – evaluate the impact of actions taken to reduce the occurrence of residues in the food animal population

ENFORCEMENT TESTING

(In-Plant Sampling) • Obtained from individual animals or lots: – to detect violative concentrations of residues from animals that appear suspicious based on herd history, ante-mortem,, or post-mortem inspection – – to follow up on producers and others that have marketed animals with violative levels of residues to verify the industry’s HACCP system

ENFORCEMENT TESTING

(Continued) •

Fast Antimicrobial Screen Test (FAST)

– replacing STOP & CAST tests – only approved for use in cattle including bob veal calves – detects both antibiotic and sulfonamide drugs •

Swab Test On Premises (STOP)

– may be used in any species – if used in calves, all zones are considered positive and tissues are sent to the lab – test has little sensitivity for sulfonamides

ENFORCEMENT TESTING “FAST” & “STOP”

• • • • • Presence of significant pathology which would indicate a likelihood of treatment Animals condemned for disease conditions where treatment was likely Injection sites Antemortem downers – Depending on pathology Violators with an open residue case

‘FAST’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT 1995 1996 1997 1998 68,139 156,078 109,021 804 1,024 472 108,020 751 1.18

0.66

0.43

0.70

‘STOP’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT 1995 1996 1997 1998 83,524 41,995 888 292 33,709 148 37,633 220 1.06

0.70

0.44

0.58

ENFORCEMENT TESTING ‘SOS’

•

Sulfa on Site

– Testing-used in market hogs only – testing protocol-one day per week – 6 samples per day (one sample per lot not to exceed 6 lots)

‘SOS’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT 1995 1996 1997 1998 155,430 15,600 10,072 11.109

43 24 9 28 0.03

0.15

0.09

0.25

ENFORCEMENT TESTING ‘CAST’

• • • •

Calf Antibiotic and Sulfonamide Test

Certified - certification the calf has not been treated, or treated within FDA label directions Noncertified - normal healthy calves selected at random for testing according to testing level tables Others - tested always at 100% and include the following: – – – – suspects carcasses showing signs of disease or treatment calves from violators with an open residue case condemned calves are not tested

‘CAST’ IN-PLANT TESTS Source: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT 1995 1996 1997 1998 58,197 21,045 11,988 8,958 848 169 55 82 1.46

0.80

0.46

0.92

1.6

1.4

1.2

1 0.8

0.6

0.4

0.2

0 COMPARISON OF IN-PLANT RESIDUE VIOLATIONS Source: USDA/FSIS/OPHS/FASD 1995 1996 YEAR 1997 1998 FAST STOP CAST SOS

RESIDUE VIOLATIONS

• FSIS Informs FDA: – Illegal drugs – – Massive violations (over 10X the tolerance) Advent of new drugs/codes (e.g. tilmicosin) • Since FDA has access to the Residue Violation Information System (RVIS), exercise good judgement in deciding if necessary

INVESTIGATIONAL NEW ANIMAL DRUGS (INAD)

• • • • • Receive initial FDA approval of INAD and enter in the database Receive request from the investigator for slaughter of animals used in the trial Review & prepare slaughter permit Will develop and maintain log on INAD For Biologic - same as INAD

INVESTIGATIONAL NEW ANIMAL DRUGS (INAD; Continued)

• INAD animals under waiver: – most INAD’s have a waiver granted by FDA under their agreement with the originating drug company that any animal going to slaughter more than 30 days beyond the withdrawal time can be slaughtered as a non-investigational animal – – no special notifications are involved the investigator is not required to notify FSIS of the slaughter of these animals which fulfill waiver requirements

IMPORT RESIDUE SAMPLING PROGRAM

• • • Countries are required to have inspection systems equivalent to the U.S.

Principle of import activities is a ‘systems approach’ – residue control is a major feature of the inspection system – are required to have residue control standards FSIS randomly samples products for reinspection at U.S. ports of entry

IMPORT RESIDUE SAMPLING PROGRAM (Continued)

• • • Reinspection of products is performance-based Residue analysis is not limited to compounds in the Domestic Residue Program Decisions of product acceptability are based on U.S. tolerances or action levels

PRODUCT DISPOSITION

• • • • TSC staff analyze and interpret test results Determine product disposition Enforcement Testing samples: – inform the IIC ASAP For Monitoring Plan samples: – have IIC make inquiry to determine if any product is still available

FOLLOW-UP ON RESIDUE CASES

• • • Red Meat Poultry Certain other selected violations: – 5 negative animals are required for pre-sampling followed by 1 negative verification sample – for a producer, this is generally five (5) consecutive negative animals • may be submitted over a period of time – for middlemen, such as dealers, order buyers, feedlots, etc.

• • fifteen (15) animals are required up to 5/week as available

CONTAMINATION RESPONSE SYSTEM - CRS

Management response system to identify potential residue crises involving pesticides or other environmental contaminants – Such as Dioxin & Alachlor – Resources utilized by CRS: • • • • • Food and Drug Administration (FDA) Environmental Protection Agency (EPA) Animal and Plant Health Inspection Service (APHIS) State Officials Agricultural Marketing Service (AMS) – poultry cases

TOTAL LIVESTOCK SLAUGHTERED BY YEAR IN U.S.

SOURCE: USDA/FSIS/OPHS/FASD (01-10-01)

160 140 120 100 80 60 40 20 0 1995 1996 1997 1998 1999 2000 PER MIL

Technical Service Center USDA/FSIS/OFO Suite 300, Landmark Center 1299 Farnam Street Omaha, NE 68102

402-221-7400 [email protected]

6am - 6pm CT

INTERNET ADDRESSES

•

TSC at FSIS:

• http://www.fsis.usda.gov/OFO/TSC/

Red Book:

• http://www.fsis.usda.gov/OPHS/red97/index.htm

Blue Book:

• http://www.fsis.usda.gov/OPHS/blue2000/index.htm

NRP 2000:

http://www.fsis.usda.gov/OPHS/nrp2000/index.htm