National Trichinae Certification Program
Program Standards

 

Contents

Introduction

These program standards were adopted to provide documentation of swine management practices which minimize risk of exposure of swine to the zoonotic parasite Trichinella spiralis. The standards establish a set of criteria that enable producers to market swine which are not considered a risk to human health due to exposure to this parasite. The standards have been developed as a cooperative effort among the USDA agencies (Animal and Plant Health Inspection Service [APHIS], Agricultural Research Service [ARS], Cooperative States Research, Education and Extension Service [CSREES], Food Safety and Inspection Service [FSIS]) the National Pork Producers Council [NPPC], and the pork processing industry. The concept of risk management for control of Trichinella in the domestic swine population is endorsed by the U. S. Animal Health Association, the National Institute for Animal Agriculture and the American Association of Swine Practitioners. It is also recognized by the International Commission on Trichinellosis in their Recommended Methods for Control of Trichinella in swine.

Part I - Definitions

Accredited Veterinarian - A veterinarian approved by the Administrator of APHIS, USDA, to perform functions required by cooperative State-Federal-Industry animal disease-control and eradication programs.

Animal Disposal Plan - A written document that describes methods for removal of dead swine from the production facility. (see example in Appendix).

Animal Movement Record - A written record of certified animal movement, which includes entry into or exit from a certified site (see example in appendix).

APHIS Administrator - The Administrator of APHIS, USDA, or any other official of APHIS to whom authority has been delegated.

Approved Laboratory - Any laboratory recognized by the APHIS or FSIS Administrator for conducting official tests.

Audit - An inspection process, as defined in these program standards, which generates a written record documenting a production sites compliance with Good Production Practices.

Auditor - A Qualified Accredited Veterinarian or a Qualified state or federal Veterinary Medical Officer .

Certification - A designation given by the APHIS Administrator to a pork production site for compliance with Good Production Practices as defined in these program standards.

Certified Pork - Certified trichinae-safe pork products originating from market swine from a trichinae certified production site with identity maintained through processing.

Certified Production Site - A pork production site which has attained a stage II status or higher as defined in these program standards.

Certified Swine- Swine originating from a certified production site.

De-Certification – Removal of certification status by the APHIS Administrator that results when program criteria are not met.

Feed Manufacturing and Storage Plan - A written plan or other documentation for the site demonstrating methods to exclude rodents and wildlife from feed during manufacturing, mixing, and storage (see example in Appendix).

FSIS Administrator - The Administrator of FSIS, USDA, or any other official of FSIS to whom authority has been delegated.

Good Production Practices - Management practices which negate or reduce the risk of exposure of swine to Trichinella spiralis (Section A, Step II).

Official Test - Any test for the diagnosis of Trichinella spiralis infection in swine which has been approved by the APHIS or FSIS Administrator.

Pest Control Operator - A person trained and licensed in the control of pests and vermin (particularly rodents).

Producer - An individual or entity who owns or controls the management of swine.

Qualified Accredited Veterinarian - AUSDA accredited veterinarian who has been awarded qualification status by the APHIS Administrator.

Qualified VMO - A state or federal VMO who has been awarded qualification status by the APHIS Administrator.

Rodent Control Log Book - A written record which documents the activities of a rodent control program for a production site.(see example in Appendix).

Rodent Control Plan - A written plan to control rodents (mice and rats) on a swine production site.

Site - A geographically definable area that includes pork production facilities and ancillary structures under common ownership and/or management systems and the space within a 100 yard perimeter of the swine feeding areas.

Site audit - An audit, performed by a Qualified Accredited Veterinarian or a Qualified Veterinary Medical Officer, to determine swine trichinae risk factor status of a pork production facility and adherence to Good Production Practices that negate or reduce trichinae infection.

Spot Audit - An audit of a trichinae certified site conducted by a Qualified APHIS Veterinary Medical Officer to ensure program integrity.

Stage 1 - Preliminary program status of a production site attained when the APHIS Administrator approves the outcome of an initial audit.

Stage 2 - Program status attained upon approval of an audit of a Stage 1 production site.

Stage 3 - Program status attained upon approval of an audit of a Stage 2 production site

Trichinae Identification Number (T.I.N.) - A unique number assigned to a site by the APHIS Administrator based on location and ownership.

Veterinary Medical Officer - A veterinarian employed by the state or federal government who is authorized to perform official animal health activities on their behalf.

Waste Feeding Log Book - A written record which documents Good Production Practices in the trichinae program standards with respect to feeding of meat-containing waste to swine and compliance with relevant state and federal waste food feeding laws (see example in Appendix).

Wildlife Control Plan - A site specific plan to minimize contact of swine with all other animals.

 

Part II - Program Stages and Requirements

Section A - Certification

Step I - Preparation

The preparatory stage of the program will introduce the certification process to the producer. A pre-audit package contains all information needed to understand the steps of the program and actions necessary to prepare for an audit. A pre-audit package may be obtained from the following sources: Qualified Accredited Veterinarians, state or federal animal health offices,, and the National Pork Producers Council, , or by writing to:

USDA, APHIS, Veterinary Services
Trichinae Certification Program
4700 River Road, Unit XX
Riverdale, Maryland 20737

A pre-audit package may also be requested electronically through the program website:

http://www.aphis.usda.gov/vs/trichinae

Producers and production site personnel, in consultation with their herd veterinarian, should thoroughly review the information in the pre-audit package. Each point within the program standards should be considered during the pre-audit process and the sample audit and the checklist completed. A request for an official audit should not be made until both the producer and herd health personnel concur that program standards have been met.

Step II - Auditing and Program Stages

Requesting an audit

When a pork producer has determined that all necessary steps have been taken to meet program standards, he/she may contact a qualified accredited veterinarian for a Stage I audit. An audit can only be performed by a Qualified Accredited Veterinarian or a Qualified Veterinary Medical Officer. A list of Qualified Accredited Veterinarians available to conduct trichinae audits can be found on the APHIS web site (http://www.aphis.usda.gov/vs/trichinae) or a list may be requested in writing from the APHIS Administrator through the area office. . If a Qualified Accredited Veterinarian is unavailable a Qualified Veterinary Medical Officer should be contacted through the area office A fee will be charged of the producer for audit related activities.

Conducting an audit

At the time of audit, the producer, or a designated representative, will accompany the Auditor. The audit will determine whether the site has implemented the following Good Production Practices:

  1. All non-breeding swine entering the site either originate from a Certified production site or are less than 5 weeks old. The source herd T.I.N. must be documented in an animal movement record. (see example in appendix)
  2. Sources of feed or feed ingredients meet Good Manufacturing Practices or quality assurance standards recognized by the feed industry.
  3. Feed prepared on the site must be prepared, stored, and delivered in a manner such that the feed has not been contaminated with rodent and wildlife carcasses.
  4. Exclusion and control of rodents and wildlife is to a level such that fresh signs of activity of these animals are not observed in the swine production or feed preparation and storage areas. The producer maintains a rodent control logbook with site diagram, or records of a Pest Control Operator, which are updated on at least a monthly basis (see example in Appendix).
  5. Wildlife carcasses are not intentionally fed to swine. Swine shall not have access to wildlife harborage or carcasses on the site.
  6. Feeding of waste containing meat is a major risk factor for swine infection with trichinae.
  1. Dead animal disposal methods shall accomplish prompt removal of swine carcasses from pens preventing cannibalism. Dead animals shall also be promptly removed from the site to prevent attraction of rodents and wildlife.
  2. General hygiene of the facility should be such that rodents and wildlife are not attracted.
  1. Departures from the site shall be documented on an animal movement record and take place in a manner that ensures the identity of these swine can be traced to their origin, the certified production site.

When all sections of the audit form have been completed, the producer (or designated representative) will sign the audit form attesting to the accuracy of audit information and the intent to continue adherence to the Good Production Practices necessary to maintain trichinae certification. The Qualified Accredited Veterinarian or Qualified Veterinary Medical Officer will also sign the audit form and will submit the signed form to the nearest APHIS Area Office (see list of addresses in Appendix).

Review and notification of audit results

Upon receipt of the completed and signed audit form in the APHIS Area Office, the audit will be reviewed and certification status for the site will be determined. Sites which meet all Good Production Practice criteria will be issued the appropriate program stage status at the appropriate program stage (see Administrative Procedures - Part III).

Program stages

The date of program entry will be determined from the date the first audit leading to Stage I status was completed. All subsequent program dates will be based on this initial date at 6, 9, or 15 month intervals as appropriate. If a site is de-certified and must be granted stage I status a new anniversary date will be established.

Stage I - Sites which have the initial audit approved by the APHIS Administrator will be granted Stage I status. Stage I status indicates that the site has met all requirements of trichinae Good Production Practices. During Stage I, swine may not be sold as trichinae certified product.

The completed and signed audit form should be sent to the appropriate APHIS Area Office. For new sites, the audit will be reviewed and determination made whether program status is to be awarded. New sites which meet all Good Production Practice criteria will be issued Stage I status within thirty (30) working days (see Administrative Procedures - Part III) of receipt of the audit form.

Stage II - Sites with Stage I status may request an audit for Stage II status no sooner than 5 months and must submit a completed audit form no later than 7 months after attaining Stage I status.

The completed and signed audit form from a Stage I site should be sent to the appropriate APHIS Area Office. For Stage I sites, the audit will be reviewed and the determination made whether Stage II status is awarded. Stage I sites which meet all Good Production Practice criteria will be issued Stage II status and trichinae certification within seven (7) working days (see Administrative Procedures - Part III) of receipt of the audit form.

Sites holding Stage II certification may sell swine as trichinae certified.

Stage III - Sites holding Stage II status may request an audit for Stage III status after 8 months and must submit a completed audit form no later than 10 months following the date of Stage II status.

The completed and signed audit form from a Stage II site should be sent to the appropriate APHIS Area Office. For Stage II sites, the audit will be reviewed and determination made whether Stage III status awarded and certification is continued. Stage II sites which meet all Good Production Practice criteria will be issued Stage III status and continuation of trichinae certification within thirty (30) working days (see Administrative Procedures - Part III) of receipt of the audit form.

Step III - Maintenance of Stage III Status and Trichinae Certification

Sites holding Stage III status must request a renewal audit no sooner than 14 months and must submit a completed audit form no later than 16 months following the most recent date of certification.

The completed and signed audit form from a Stage III site should be sent to the appropriate APHIS Area Office. For Stage III sites, the audit will be reviewed and status will be determined. Stage III sites which meet all Good Production Practice criteria will be issued Stage III status and continuation of certification within thirty (30) working days (see Administrative Procedures - Part III) of receipt of the audit form.

Change of producer identity

Within sixty (60) days of a change in ownership and/or management of Stage II or Stage III sites, an audit must be conducted. If this audit is satisfactory, certification will continue in Stage II status (note, change in ownership will require new Stage III status). If the audit results do not meet program requirements, as determined by APHIS, the site is de-certified and a new audit must be conducted to achieve Stage I status.

 

Section B - Identification and Transport

All Stage II and Stage III certified swine sold to other producers, to buying stations, or to slaughter facilities must be identified or segregated in such a way that they can be identified with a certified production site. This must be documented in a generic animal movement record. Failure to appropriately identify or segregate swine during transport or sales process will result in loss of program status and certification of the swine.

Section C - Packer Responsibilities

Verification of Certification

It is the responsibility of the slaughter facility receiving swine originating from certified production sites to verify that certification is current. This is done by: 1) verifying the producer certification status by accessing the APHIS trichinae certification web site at (http://www.aphis.usda.gov/vs/trichinae), 2) calling the APHIS Area Office to inquire, or 3) maintaining certification documentation on file.

Segregation of Swine and Pork Products from Certified Sites

For swine originating from a Stage II or Stage III certified site to be sold into commerce as certified pork, the packer/collection point must have in place a procedure by which swine from certified sites, and edible pork products from certified swine, are segregated from swine and edible pork products from non-certified sites.

Validation of the Certification Program by Testing Slaughter Swine

Slaughter facilities processing swine from Stage II or Stage III trichinae certified sites are responsible for conducting testing to determine Trichinella spiralis infection status of incoming certified swine as required by USDA, FSIS. Process verification testing will be performed by accepted tissue or blood-based postmortem tests. Testing will be the responsibility of plant personnel using USDA approved methodologies under the oversight of the Food Safety and Inspection Service. Testing may be conducted on site using an official test; or, as an alternative, blood, serum or tissue samples can be collected at slaughter and tested by a USDA approved laboratory. Any test used must be an official test.

Testing must be conducted to meet the following minimum sampling requirements:

  1. Plant officials shall determine the yearly processing capacity of the plant for the next 12 months. Officials may use the processing capacity during the past 12 months if the past 12 months represented a typical year.
  2. Plant officials shall estimate the percentage of swine processed that will likely originate from Certified Production Sites considering all swine expected to be processed during the year. Swine originating from Certified Production Sites (Certified Swine) are considered the eligible population to be sampled.
  3. Use the Trichinae Certification In-plant Sample Size Determination Table to find the number of samples to collect from Certified Swine. If the eligible population is not listed, round up to the next larger number. Select the number of samples to collect from the column reflecting a 99% confidence level. The number selected from this table will be the total number of samples that plant officials must collect and test during the next 12 months.

Trichinae Certification In-plant Sample Size Determination

Population of Swine from Certified Sites Processed per Plant per Year

Samples to Collect from the Population per Year at a 95% Confidence Level

Samples to Collect from the Population per Year at a 99% Confidence Level

Samples to Collect from the Population per Month at a 95% Confidence Level

Samples to Collect from the Population per Month at a 99% Confidence level

1,000

1,000

1,000

84

84

5,000

4,950

4,996

413

417

25,000

15,054

18,938

1,255

1,578

100,000

20,580

29,828

1,715

2,486

200,000

21,765

32,462

1,813

2,705

400,000

22,391

33,899

1,866

2,825

1,000,000

22,779

34,802

1,898

2,900

2,000,000

22,910

35,110

1,909

2,926

4,000,000

22,976

35,266

1,915

2,939

5,000,000

22,990

35,297

1,916

2,942

  1. Divide this number by 12. This result represents the number of samples to collect from Certified Swine each month.
  2. In order to select samples at random from the eligible population, it is recommended to determine the number of samples to collect each day the plant is operational. Divide the total number of Certified Swine to be processed each day by the number of samples to be collected each day. This number will determine the frequency of sampling. The first sample should be collected from an eligible carcass selected at random. Maintain the sampling frequency from this point until the required number of samples have been collected for the day. To ensure selection is random, the sampling procedure is complex. Therefore it is recommended, Certified Swine be maintained in lots and processed in groups either at the beginning or at the end of the day.
  3. For each sample collected, plant officials shall maintain identity of the sample back through the Trichinae Identification Number to the owner from which the carcass originated.
  4. FSIS officials at the plant will review and confirm an adequate number of samples are collected and proper frequency of collection is maintained. FSIS officials should review and confirm sample handling, sample identification, and if tested at the plant, sample assay methods do meet the standards outlined in the respective plant’s standard operating procedures for sample processing and testing. FSIS shall report each month to APHIS the total number of samples collected and the results of the testing. If a positive test result occurs, FSIS shall contact plant officials and determine the Trichinae Identification Number and report this information to the respective USDA, APHIS Area Office.

The APHIS Administrator may periodically request that testing be conducted on swine originating from a specific certified production site. Requests for testing of specific groups of swine will be counted toward the plants total monthly testing requirement of certified pigs.

This verification phase is not expected to continue for an extended period of years.

Results of testing

A positive test will result in the following:

  1. If a sample is found positive by digestion methods, the production site of origin is de-certified and removed from the program.
  2. If a serologic positive sample is confirmed positive by digestion methods, the production site of origin is de-certified and removed from the program.
  3. If a serologic positive sample can not be confirmed by digestion testing, the production site of origin must be investigated by APHIS personnel and additional testing of animals conducted. An assessment of trichinae risk will be determined based on these investigations. During this investigation period, site certification is suspended. The Administrator will determine the status of the site within 30 days of the suspension initiation. A finding of risk, based on factors addressed in the trichinae audit or finding of additional positive animals by either serologic or digestion testing will be grounds for de-certification.

Record Keeping

All packers receiving swine from certified production sites must maintain the records for numbers of swine processed, source of swine, TIN of tested swine and test results.

 

Part III - Administrative Procedures

Certification Processes

Obtaining official audit materials - Producers, or their designated representatives, must request an official audit through a Qualified Accredited Veterinarian. QAV’s obtain official audit forms from their APHIS Area office. These forms are numbered and can not be duplicated locally.

The Producer and QAV arrange for a time to conduct the audit. The audit form must be completed by the Auditor, and signed by both Auditor and Producer.

If a QAV is not available to conduct an audit for a specific site, the Producer may request an audit through the APHIS Area office. In this case, a Qualified VMO will be asigned to conduct the audit. The QVMO and Producer will arrange a time for the audit to be conducted. The audit form will be completed by the Auditor and signed by the Auditor and the Producer.

Filing and processing of audit - Following completion of an initial audit, or audit of a Stage II or III site (Part II, Section A), the signed report is submitted with the non-refundable administrative fee (see appendix for schedule) to the APHIS Administrator and, upon receipt, will be processed within thirty (30) days working days. Audits from sites which hold Stage I status, and are awaiting certification, will be processed within seven (7) working days. For the purpose of determining when program audits are required, program entry date will be calculated as the date of the initial audit.

Continuation of certification - Two months prior to the program status expiration date, the APHIS Administrator will notify the producer by mail, of the certification renewal date. The producer will arrange for a Qualified Accredited Veterinarian to conduct the audit within 30 days either side of the program status expiration date and the completed audit will be sent along with the registration fee to the APHIS Area Office.

If a renewal application is not received in the APHIS Area Office within 30 days after the program status expiration date, the site will be de-certified. Reentry of de-certified sites will follow the procedures required for receiving Stage I status. If certification status is lost, either due to failure to adhere to program standards or failure to adhere to the audit schedule, producers are responsible for alerting packers as to the change in status.

Program records - Records of audits and certification will be maintained by the APHIS Administrator and will be considered a confidential business record. The following information will be distributed or otherwise available:

Result of site audit: Mailed to Producer and Qualified Accredited Veterinarian or the Federal or State VMO who performed the audit
Notice of program status: Mailed to Producer
List of certified sites:  Available electronically to slaughter facilities and program officials via the internet, or by mail from the APHIS Administrator
List of Qualified Accredited Veterinarians : Available electronically via the internet at programweb site, or by mail from the APHIS Administrator.

Spot audits - Certified sites will be subject to spot audits conducted by Qualified APHIS VMOs. Sites to be spot audited are selected by the APHIS Administrator. Spot audits are intended to confirm the results of regular audits, to verify that Good Production Practices are being maintained between audits, to traceback and investigate positive slaughter test results, and to assure that the audit process is conducted in a consistent manner across the program. Spot audits are provided as a government service by APHIS and do not incur a cost to the producer.

Web-site access - Access to the program web site is through (http://www.aphis.usda.gov/vs/trichinae).

 

Part IV - Training for Qualified Accredited Veterinarians

Veterinarians wishing to participate as Auditors in the Trichinae Herd Certification program must be trained by APHIS or designee(s). Accreditation by the USDA, Animal and Plant Health Inspection Service is a prerequisite for acquiring Qualified Accredited Veterinarian status. Only Qualified Accredited Veterinarians or qualified VMOs may conduct audits and submit completed audit forms for APHIS certification review.

Accredited veterinarians interested in becoming Qualified Accredited Veterinarians can obtain information from the following sources: APHIS Area office or program website (http://www.aphis.usda.gov/vs/trichinae), the American Association of Swine Practitioners, the National Pork Producers Council, and state veterinarians. Veterinarians wishing to become accredited so that they may pursue the qualification status, should contact the APHIS Area (for their state) Office.

For the purposes of this program, Qualified Accredited Veterinarian status will be issued for a two year period subject to renewal.

 

Part V - Documentation

Program Status

When a site is audited and found to meet the requirements of the program, the producer will receive written notification and of program status. If an audit is performed on a Stage I site, the producer will receive additional documentation from APHIS indicating that the pork produced at the audited production site is certified as trichinae-safe. If results of the audit do not meet program standards, similar notification will be provided, along with written documentation of deficiencies. The producer should subsequently contact their veterinarian to begin efforts to correct any deficiencies that prevented attaining program status.

Certificates for Stage II or Stage III status in the program must be filed at the site and available for inspection during normal business hours. Copies of program certification should also be kept on file at the slaughter facility.

Part VI - Flow of Events in Certification

Diagram

Part VII Appendices

  1. Animal Disposal Plan (MS Word document)
  2. Animal Movement Record (MS Word document)
  3. Rodent Control Logbook (MS Word document)
  4. Waste Feeding Log (MS Excel spreadsheet)