NATIONAL RESIDUE NATIONAL RESIDUE PROGRAM (NRP)PROGRAM (NRP)

Food Safety and Inspection ServiceFood Safety and Inspection Service

NRPNRP

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 PROGRAMNRP

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 PROGRAMNRP

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 2000

• Monitoring Plan 32,280 37,480

• Special Projects 5,800 2,770

• Import (Port of Entry) 8,688 7,395

TOTAL 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 Carbadox

Avermectins Tilmicosin

Beta Agonists Tranquilizers

Sulfonamides CHC/COP

Antibiotics Others

Flouroquinolones

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 TESTSSource: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT

1995 68,139 804 1.18

1996 156,078 1,024 0.66

1997 109,021 472 0.43

1998 108,020 751 0.70

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

YEAR NUMBER VIOLATIONS PERCENT

1995 83,524 888 1.06

1996 41,995 292 0.70

1997 33,709 148 0.44

1998 37,633 220 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 TESTSSource: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT

1995 155,430 43 0.03

1996 15,600 24 0.15

1997 10,072 9 0.09

1998 11.109 28 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 TESTSSource: USDA/FSIS/OPHS/FASD

YEAR NUMBER VIOLATIONS PERCENT

1995 58,197 848 1.46

1996 21,045 169 0.80

1997 11,988 55 0.46

1998 8,958 82 0.92

COMPARISON OF IN-PLANT RESIDUE VIOLATIONSSource: USDA/FSIS/OPHS/FASD

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1995 1996 1997 1998YEAR

PE

RC

EN

T 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)

0

20

40

60

80

100

120

140

160

1995 1996 1997 1998 1999 2000

PER MIL

Technical Service CenterTechnical Service Center

USDA/FSIS/OFOUSDA/FSIS/OFO

Suite 300, Landmark CenterSuite 300, Landmark Center

1299 Farnam Street1299 Farnam Street

Omaha, NE 68102Omaha, NE 68102402-221-7400402-221-7400

Tech.Center@usda.govTech.Center@usda.gov

6am - 6pm CT6am - 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