**National Trichinae Certification Program (Pilot)**

**F**requently **A**sked **Q**uestions

July 25, 2000

1\. **What is the National Trichinae Certification Program?** The
National Trichinae Certification Program is a pre-harvest pork safety
program that will provide documentation of swine management practices
which minimize risk of exposure of swine to the zoonotic (animal to
human transmission) parasite *Trichinella spiralis*. The program
establishes 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.

2\. **Who was involved in researching and developing the program?** This
program has been developed as a cooperative effort among several 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. This Program
is seen as model for future on-farm animal agriculture food safety
programs.

3\. **Is trichinae a problem in pigs raised in the United States?** The
Centers for Disease Control and Prevention reported that cases of human
trichinellosis have declined to below 25 annually over the past several
years. Only a few of these cases have been traced and associated with
consumption of pork. A USDA, National Animal Health Monitoring System
national swine survey conducted in 1995 reported the infection rate in
United States swine to be 0.013%. Modern swine management systems have
virtually eliminated trichinae as a problem in domestic pigs.

4\. **Why consider trichinosis as the primary pathogen for an on-farm
certification program?** Despite what we know about the decline of
trichinae in pigs, it remains an issue of public perception. In 1994,
the question most often asked by consumers to the USDA Meat and Poultry
Inspection's (FSIS') Hotline was related to safety concerns about
trichinae in pork. The USDA Pathogen Reduction/HACCP Systems have been
implemented in meat and poultry slaughter and processing plants. Meat
processors will likely require more information about on-farm food
animal production practices to ensure these practices are in synchrony
with what the plant sees as food quality assurance demands by their
customers. Furthermore, many international trading partners require pork
produced in the United States to either originate from a carcass testing
negative for trichinae or to be processed by freezing, curing or cooking
to ensure that any trichinae, if present, are inactivated. An on-farm
certification program will assure that all trichinae infection risks are
eliminated from the production environment and swine are never exposed
to the parasite.

5\. **How are pigs exposed to trichinae?** *Trichinella spiralis* is a
parasite of mammals. It is a small-sized nematode (worm) that produces
larvae that migrate to and encyst in striated muscle tissue.
Transmission of this parasite requires consumption of the muscle
containing encysted larve by another meat eating or scavenging mammal.
The encysted larva develops into an adult and repeats the life cycle as
described. Trichinae is more likely to be found in any mammal that eat
the meat of another animal infected with trichinae. Meat eating
wildlife, rats, and swine exposed to and consuming wildlife, rats or raw
meat are at risk of becoming infected with trichinae.

6\. **How do you prevent pigs from becoming infected with trichinae?**
Producers can prevent swine from becoming infected with trichinae by
preventing the consumption of trichinae

infected meat by swine. Swine typically become infected with trichinae
by consuming undercooked food waste containing meat, ingestion of
wildlife carcasses or rat carcasses, and cannibalism of trichinae
infected swine carcasses. Care must also be taken to maintain a clean,
hygienic production environment that does not attract wildlife or
rodents.

7\. **What is the objective of the National Trichinae Certification
Program?** The objective of this voluntary program is to provide
information about trichinae to the producer. Directions provide methods
on raising swine to prevent exposure to these trichinae risk factors.
These methods are termed Good Production Practices. Pork produced under
Good Production Practices that eliminate swine exposure to the parasite
will be recognized as trichinae-safe.

8\. **What steps are required to establish a Trichinae Certified Status
for a herd?** The National Trichinae Certification Program is guided by
a set of Program Standards. These standards detail the procedures for
meeting, establishing and maintaining the requirements necessary to be
recognized as Trichinae Certified. These standards are organized into
eight parts: definitions, program responsibilities and requirements,
administrative procedures, Qualified Accredited Veterinarian training,
certification documentation and benefits, flow of events for
certification, appendices, and references. To obtain a copy of these
standards call or write an APHIS area office or access the trichinae
website at: **[http://www.aphis.usda.gov/vs/trich/]{.underline}**

9\. **What are the terms and definitions necessary to understand this
program?**

The following list of definitions have been selected to represent the
terminology used for this program in a concise manner. A complete set of
definitions pertaining to this program are contained in the Program
Standards.

***Animal and Plant Health Inspection Service*** - The Animal and Plant
Health Inspection Service of the United States Department of Agriculture
(APHIS).

***Audit*** - An inspection process 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.

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

***Certified Swine**-* Swine originating from a certified production
site.

***Good Production Practices*** - Management practices which negate or
reduce the risk of exposure of swine to *Trichinella spiralis*.

***Qualified Accredited Veterinarian*** ***(QAV)*** - A USDA accredited
veterinarian who has been awarded qualification status by the APHIS
Administrator.

***Qualified Veterinary Medical Officer (QVMO)*** - A state or federal
VMO who has been awarded qualification status by the APHIS
Administrator.

***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 (QAV) or a Qualified Veterinary Medical Officer (QVMO), to
determine 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 Veterinary Medical Officer to ensure program integrity.

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

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

***Stage 3, certified*** - 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.

10\. **What is the role of the producer in the program?** The producer
should obtain a preaudit package that contains all the information
needed to understand the steps of the program and actions necessary to
prepare for an audit. A preaudit package may be obtained from the
following sources: Qualified Accredited Veterinarians (QAV), state or
federal animal health offices, the National Pork Producers Council, or
by writing to:

USDA, APHIS, Veterinary Services

Trichinae Certification Program

4700 River Road, Unit 46

Riverdale, Maryland 20737

A preaudit package may also be requested electronically through the
program's web site:

**[http://www.aphis.usda.gov/vs/trich/]{.underline}**

You and your QAV should complete the sample audit included in the
preaudit package to be assured these standards have been met.

Once assured these Standards have been met, have the QAV perform a site
audit. Both the owner and auditor should sign the audit form and mail it
to the APHIS Area Office for review. The application fee that is
required to accompany this audit form has been waived for producers
participating in this Pilot. If the audit is approved, the appropriate
status for the site will be issued and documentation will be mailed to
the producer. The producer is expected to maintain these standards and
good production practices between audits.

11\. **What are the key elements for trichinae certification?**

The key elements are listed below. These elements will be observed by
the QAV during the audit. The purpose of an audit is to document
implementation of the following Good Production Practices which
eliminate the possibility for swine to become trichinae infected. The
Good Production Practices ensure that:

A. 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.

B. Sources of feed or feed ingredients meet Good Manufacturing Practices
or quality assurance standards recognized by the feed industry. A letter
from the source(s) of feed shall be maintained on file and available for
review by the auditor.

C. 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.

D. 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. These records
shall be maintained on file and available for review by the auditor.

E. Wildlife carcasses are not intentionally fed to swine. Swine shall
not have access to wildlife harborage or carcasses on the site.

F. Swine are not fed improperly cooked or improperly prepared waste food
containing meat.

• Feeding of waste food to swine requires state licensing and cooking
time and temperature consistent with state and federal regulations.
Storage of waste products to be fed must avoid contamination of cooked
material with uncooked material. Records logging cooking times and
temperatures shall be maintained on file and available for review by the
auditor.

• Uncooked household waste shall not be fed to swine.

G. 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. An Animal Disposal Plan describing these procedures shall be
maintained on file and available for review by an auditor.

H. General hygiene of the facility should be such that rodents and
wildlife are not attracted.

• Solid waste (facility refuse) shall be contained and regularly removed
from the site preventing rodent and wildlife access and attraction.

• Spilled feed shall be regularly removed.

I. 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.
Animal movement records shall be maintained on file and available for
review by the auditor.

12\. **What steps are necessary to attain and maintain Certification?**

Sites will be audited several times to document the standards have been
implemented initially and to ensure that swine have been raised under
these standards during the period they have been located at the site.
Three stages were established to document the verification of this
certification process.

[Program stages]{.underline}

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 decertified and must be granted stage I
status a new anniversary date will be established.

***Stage I, enrolled*** - Sites which have the initial audit approved by
APHIS will be granted Stage I status. Stage I status indicates that the
site has met all requirements of trichinae Good Production Practices and
the site is officially "Enrolled" in the trichinae program. During Stage
I, swine may **[not]{.underline}** be sold as trichinae certified.

***Stage II, certified*** - Sites with Stage I status [may]{.underline}
request an audit for Stage II status no sooner than 5 months and must
submit a completed audit form by no later than 7 months after attaining
Stage I status. Audits reviewed and approved by APHIS will be issued
Stage II status. **Swine originating from Stage II sites may be sold as
trichinae certified product.**

***Stage III, certified*** - Sites holding Stage II status
[may]{.underline} request an audit for Stage III status no sooner than 8
months and must submit a completed audit form by no later than 10 months
following the date of Stage II status. Audits reviewed and approved by
APHIS will be issued Stage III status. **Swine originating from Stage
III sites may be sold as trichinae certified product.**

In order to maintain a Stage III, certified status, the owner of the
site [must]{.underline} request a renewal audit no sooner than 14 months
and must submit a completed audit form by no later than 16 months
following the most recent date of certification. Audits reviewed and
approved by APHIS will be issued a continuation of Stage III, certified
status. Certified site will be decertified if audits are not completed
and the forms not received by APHIS within the time period stated.

13\. **Is certification transferable if either ownership or management
of the pigs or ownership of the site changes?**

If either the ownership of the Certified Production Site or the
ownership and management of swine located at the Certified Production
Site changes, the site must be audited within 60-days of this change to
maintain the current Certification and Stage status. Sites not meeting
change-of-ownership audit requirements within 60-days will be
decertified. Decertified sites will be required to repeat the 3-stage
certification process described above beginning with Stage I.

14\. **What is the role of government in this program?** The USDA will
be endorsing this program on behalf of the U.S. Swine Industry and be
involved with the following:

A. One of several sources distributing information about the program.

B. Train USDA accredited veterinarians to become Qualified to conduct
audits.

C. Maintain a current list of Certified Production Sites and Qualified
Accredited Veterinarians.

D. Review audit results submitted by an auditor and issue status if
standards have been met and approved.

E. Detail a Qualified Veterinary Medical Officer to conduct random spot
audits to ensure the integrity of the on-farm auditing process.

F. Provide a Qualified Veterinary Medical Officer for a user fee to a
producer to conduct audits if a Qualified Accredited Veterinarian is not
available.

15\. **What is a Spot Audit?** Spot audits will be conducted to ensure
the integrity of the auditing process. Certified Production Sites will
be randomly audited by a QVMO. The QVMO will conduct an audit and
document the findings on an official audit form at no charge to the
producer. The completed audit form will be submitted to APHIS. If
approved, APHIS will grant continuation of the Certified status. Spot
audits will also be conducted by a QVMO due to detection of a positive
test result during validation of the certification program by testing
slaughter swine as described in the Program Standards.

16\. **How will swine originating from a Certified Production Site be
identified and maintained separate from other swine in order to maintain
their Certified Swine status?**

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 to a Certified
Production Site. Failure to appropriately identify or segregate swine
during transport or sales process will result in loss of program status
and certification of the swine.

17\. **How will packing plants verify swine originate from Certified
Production Sites?**

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
(**[www.aphis.usda.gov/vs/trich]{.underline}**), 2) calling the APHIS
Area Office to inquire, or 3) maintaining documentation of certification
on file. 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 either swine from
certified sites or edible pork products from certified swine, are
segregated from swine or edible pork products originating from
non-certified sites.

18\. **Will there be other testing to ensure the on-farm certification
program is effective?**

Yes, 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 on blood or muscle samples obtained during slaughter and
assayed 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.

19\. **What happens if testing conducted at the packing plant detects a
trichinae positive sample?**

Detection of a positive testing sample will result in a tracing back to
the site of origin and the following:

A. If a sample is found positive by digestion methods, the production
site of origin is

decertified and removed from the program.

B. If a serologic positive sample is confirmed positive by digestion
methods, the production site of origin is decertified and removed from
the program.

C. 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
the investigation period, site certification is suspended. APHIS will
determine the status of the site within 30 days of the suspension
pending the results of the investigation. 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 result in
de-certification.

20\. **What are the record keeping requirements for packing plants,
producers, and APHIS?**

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

All producers seeking to obtain a certification or maintaining a
Certified Production Site are required to maintain the following records
if applicable: Feed Production Log, Feed Manufacturer's Quality
Assurance Verification, Rodent Control Log or Pest Management
Professional's Log, Disposal Plan, Animal Movement Record, and Waste
Feeding Log. APHIS will maintain a list of Certified Production Sites, a
list of Qualified Accredited Veterinarians, results of in-plant testing
of slaughter swine, and audit events.