27656 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Proposed Rules 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 149, 160, and 161 

[Docket No. APHIS–2006–0089] 

RIN 0579–AB92 

Trichinae Certification Program 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: We are proposing to establish 

a voluntary Trichinae Certification 

Program for U.S. pork that has been 

produced under disease-prevention 

conditions. Under the proposed 

program, we would certify pork 

production sites that follow prescribed 

good production practices that reduce, 

eliminate, or avoid the risk of exposure 

of animals to the zoonotic parasite 

Trichinella spiralis, a disease of swine. 

Such a program should enhance the 

ability of producers to export pork and 

pork products to overseas markets. This 

proposed program, which would be 

funded by program fees, has been 

developed as a cooperative effort by the 

U.S. Department of Agriculture, the 

National Pork Board, and the pork 

processing industry. If adopted, this 

program would include those producers 

who choose to participate in the 

program, as well as slaughter facilities 

and other persons that handle or process 

swine from pork production sites that 

have been certified under the program. 

DATES: We will consider all comments 

that we receive on or before July 16, 

2007. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov, select 

‘‘Animal and Plant Health Inspection 

Service’’ from the agency drop-down 

menu, then click ‘‘Submit.’’ In the 

Docket ID column, select APHIS–2006– 

0089 to submit or view public 

comments and to view supporting and 

related materials available 

electronically. Information on using 

Regulations.gov, including instructions 

for accessing documents, submitting 

comments, and viewing the docket after 

the close of the comment period, is 

available through the site’s ‘‘User Tips’’ 

link. 

• Postal Mail/Commercial Delivery: 

Please send four copies of your 

comment (an original and three copies) 

to Docket No. APHIS–2006–0089, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2006–0089. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

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

FOR FURTHER INFORMATION CONTACT: Dr. 

Dave Pyburn, National Trichinae 

Coordinator, VS, APHIS, 210 Walnut 

Street Room 891, Des Moines, IA 50309; 

(515) 284–4122. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the Animal Health Protection 

Act (7 U.S.C. 8301–8317), the 

Administrator of the U.S. Department of 

Agriculture’s (USDA’s) Animal and 

Plant Health Inspection Service (APHIS) 

may carry out operations and measures 

to detect, control, or eradicate any pest 

or disease of livestock (including the 

drawing of blood and diagnostic testing 

of animals). Such operations can 

include animals at a slaughterhouse, 

stockyard, or other point of 

concentration. The Administrator may 

also cooperate with State authorities, 

Indian tribe authorities, or other persons 

in the administration of regulations for 

the improvement of livestock and 

livestock products. For example, APHIS 

administers regulations in subchapter G 

of chapter I, title 9, of the Code of 

Federal Regulations (CFR) that address 

poultry improvement through the 

National Poultry Improvement Plan 

(NPIP). The NPIP is a cooperative 

Federal-State-industry mechanism 

consisting of a variety of programs 

intended to prevent and control eggtransmitted, hatchery-disseminated 

poultry diseases. As a result, customers 

can buy poultry or poultry products 

from flocks that have been certified free 

of certain diseases or produced under 

disease-prevention conditions. 

APHIS’ regulations in 9 CFR parts 160 

through 162 govern the accreditation of 

veterinarians. Accredited veterinarians 

are approved by the APHIS 

Administrator to perform certain 

regulatory tasks to control and prevent 

the spread of animal diseases 

throughout the United States. 

Under the Federal Meat Inspection 

Act (FMIA), as amended (21 U.S.C. 601 

et seq.), and the Poultry Products 

Inspection Act (PPIA), as amended (21 

U.S.C. 451 et seq.), the USDA’s Food 

Safety and Inspection Service (FSIS) 

inspects meat and poultry slaughtered 

or processed at official establishments. 

Such inspection is required to ensure 

the safety, wholesomeness, and proper 

labeling of meat and poultry. In addition 

to mandatory inspection, FSIS, under 

the authority of the Agricultural 

Marketing Act of 1946, as amended (7 

U.S.C. 1621–1627), provides a range of 

voluntary inspection, certification, and 

identification services to assist in the 

orderly marketing of various animal 

products and byproducts. FSIS 

regulations covering inspection and 

other related activities are found at 9 

CFR chapter III. 

Under the Agricultural Marketing Act 

of 1946, USDA’s Agricultural Marketing 

Service (AMS) provides analytical 

testing services that facilitate marketing 

and allow products to obtain grade 

designations or meet marketing or 

quality standards. Pursuant to this 

authority, AMS develops and maintains 

laboratory certification and approval 

programs as needed by the agricultural 

industry, to support domestic and 

international marketing of U.S. 

products. 

Trichinae In Swine 

Trichinella spiralis is a parasitic 

nematode (roundworm) that is found in 

many warm-blooded carnivores and 

omnivores, including swine. Trichinae 

is a generic term that refers to 

Trichinella spiralis. Trichinae has a 

direct life cycle, which means it 

completes all stages of development in 

one host. Transmission from one host to 

another host can only occur by ingestion 

of muscle tissue that is infected with the 

encysted larval stages of the parasite. 

When ingested, muscle larvae are freed 

from the cyst by digestion in the 

stomach and then enter tissues of the 

small intestine, where they undergo 

development to the adult stage. Male 

and female adult parasites mate, and the 

females produce newborn larvae that 

leave the intestine and migrate through 

the host circulatory system to striated 

muscle tissue. There, the larvae 

penetrate a muscle cell, modify it to 

become a unique cyst, and mature to 

become infective for another host. The 

total time required for this to occur is 

from 17 to 21 days. Adult males die 

after mating, but adult females continue 

to produce larvae in the host for several 

weeks before they die and are expelled. 

Once adult worms are expelled and 

larvae reach and encyst in musculature, 


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no further contamination can occur. 

Animals that are infected with trichinae 

are at least partially resistant to a 

subsequent infection due to a strong and 

persistent immunity. 

Trichinae may be passed on to 

humans who consume undercooked 

meat infected with the encysted 

parasite. Humans who are infected with 

the parasite generally experience flulike symptoms, such as fever. 

Trichinae has a longstanding 

association with swine and pork 

products, not only in the United States 

but around the world. The concept that 

many people have about the need to 

cook pork thoroughly is based on the 

risk of becoming infected with this 

parasite. The historical problem of 

trichinae infection in swine is the basis 

for strict Federal regulations relating to 

the methods used to prepare ready-toeat pork products. 

Despite the historical problems of 

trichinae and its association with the 

pork industry, changes have occurred in 

the last 50 years that have caused a 

major decline in the prevalence of this 

parasite in swine raised in the United 

States. 

Historically, trichinae infection in 

swine was associated with feeding them 

raw meat waste products. Major inroads 

with respect to the reduced incidence of 

trichinae infection occurred with the 

advent of meat waste cooking laws in 

response to vesicular exanthema (1953–

1954) and the hog cholera eradication 

program (1962). Of equal importance 

has been the movement to high levels of 

biosecurity and hygiene under which 

most U.S. swine are now raised as 

producers increasingly use intensive 

management systems in raising swine. 

Despite the fact that trichinae is rare 

in today’s U.S. swine industry, pork still 

suffers from its historical association 

with the parasite. Today, the trichinae 

issue is a question of perception versus 

reality. Human cases of trichinellosis 

reported to the Centers for Disease 

Control and Prevention declined from 

about 500 per year in the 1940’s to fewer 

than 50 per year over the last decade. 

Further, many of these cases resulted 

from non-pork sources such as bear and 

other game meats. However, the 

dramatic declines in the prevalence of 

trichinae in U.S. swine and the 

extremely low number of cases in 

humans in the United States remain 

largely unrecognized by consumers and 

our trading partners. 

Today, exposure of domestic swine to 

trichinae is limited to just a few risk 

factors that include: Consumption by 

swine of uncooked meat waste products 

contaminated with trichinae, 

consumption of rodents or other 

wildlife infected with trichinae, and 

cannibalism among swine within an 

infected herd. Generally, the way that 

swine become infected can be 

determined by a simple evaluation of 

farm management practices. Since it is 

illegal to feed raw meat waste products 

to swine, this particular source of 

infection should never be an issue. 

However, feeding of any raw or 

undercooked meat scraps, including 

table waste, does pose a risk. Of much 

greater significance is the exposure of 

swine to rodents and wildlife infected 

with trichinae. Rodents, and rats in 

particular, serve as a reservoir host for 

trichinae infection. Rodents can pick up 

infection from landfills, carrion, or even 

dead swine. When rat populations are in 

close proximity to swine, it is possible 

that either live or dead rats will be 

caught and eaten by the swine. If the rat 

happens to be infected, then trichinae 

infection will occur. The same type of 

risk holds true for other small mammals. 

Swine that have free range to browse 

outdoors occasionally encounter 

carcasses that they may consume. Small 

mammals that have been shown to have 

higher prevalence rates for trichinae 

include raccoons, skunks, and 

opossums. The risk of exposure of swine 

to trichinae at the production site can be 

greatly reduced, if not eliminated, by 

taking the following steps: 

• Do not feed uncooked waste 

products, table scraps, or animal 

carcasses to swine. This is particularly 

important in the case of carcasses from 

hunted or trapped wildlife. 

• Eliminate or minimize the exposure 

of swine to live wildlife. Create barriers 

that are effective in separating swine 

from skunks, raccoons, and other small 

mammals. 

• Implement and maintain an 

effective rodent control program at the 

pork production site. Biosecurity, 

maintaining perimeters, baiting, and 

trapping are all part of rodent control. 

• Maintain good hygiene at the pork 

production site. Remove dead swine as 

soon as they are found. Keep barns free 

from clutter and store feed securely. 

Trichinae Control 

Despite the relatively low prevalence 

of trichinae in swine in many developed 

countries, considerable energy goes into 

preventing human exposure to this 

parasite. There are a variety of ways in 

which trichinae control is approached. 

A number of countries require slaughter 

testing of each carcass. In fact, for pork 

exported to the European Union (EU), 

packers in the United States test 

carcasses using the same methods 

employed by European meat inspectors. 

While the need for such measures may 

no longer seem as immediate, given that 

trichinae is almost nonexistent in U.S.- 

produced pork, it is apparent that some 

organized approach to demonstrating 

product safety is still needed for 

overseas markets. The following 

discussion summarizes the potential 

methods that are currently used for 

trichinae control. 

Slaughter Testing 

Many countries require slaughter 

testing of each carcass. Such testing is 

largely a continuation of measures 

implemented when trichinae was a 

serious problem. In many countries, 

slaughter inspection programs are 

required. 

Approved slaughter testing methods 

for trichinae in swine include direct 

methods for visualization of parasites. 

Since it is not possible to see trichinae 

cysts within meat tissue by macroscopic 

examination, it is necessary to perform 

one of several laboratory tests. The 

oldest method, and one still frequently 

used, is called the compression method. 

Small pieces of pork collected from the 

pillars (crus muscle or hanging 

tenderloin) of the diaphragm are 

compressed between two thick glass 

slides (a compressorium) and examined 

microscopically for the presence of 

Trichinella spiralis larvae. 

An improvement over the 

compression method, and a method that 

is now widely used in Europe, is the 

pooled sample digestion method. 

Samples of tissue collected from sites 

where parasites concentrate, such as the 

diaphragm, masseters, or tongue, are 

subjected to digestion in acidified 

pepsin. Larvae, which are freed from 

their muscle cell cysts by this process, 

are recovered by a series of settling 

steps, then visualized and counted 

under a microscope. Requirements for 

performing the digestion test are found 

in the Directives of the European 

Economic Community, in the FSIS 

regulations in 9 CFR 318.10(e), and in 

various other publications. 

Another method of testing swine for 

trichinae infection is an indirect method 

that looks for antibodies to the parasites 

in swine sera, plasma, whole blood, 

tissue fluid, or meat juice. The enzymelinked immunosorbent assay (ELISA) 

method has been used extensively for 

testing in both pre- and post-slaughter 

applications and is an extremely useful 

tool for determining or monitoring 

trichinae infection in herds. 

Where fresh pork is not routinely 

tested for trichinae, as is the case in the 

United States, alternative measures are 

used to prevent exposure of humans to 

potentially contaminated product. 

These include processing methods such 


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as cooking, freezing, irradiation, and 

curing along with recommendations to 

the consumer concerning the need for 

thorough cooking. 

In lieu of carcass testing or treatment 

to show that swine or pork product is 

not infected or contaminated, there are 

still other means to ensure the safety of 

the product. These include herd testing 

to prove that trichinae infection is not 

present in a particular geographical 

region (i.e., certification by region) or 

raising swine under prescribed 

conditions that reduce, eliminate, or 

avoid the risk of exposure of swine to 

trichinae (i.e., certification of individual 

pork production sites). In the former 

case, considerable testing on a regular 

basis is required to document the 

absence of infection. In the latter case, 

documentation of good production 

practices is necessary to show that 

swine have not had an opportunity to 

become exposed to or infected with 

trichinae. 

Certification By Region 

The basis for a regional approach to 

certification is found in the Office 

International des Epizooties (OIE) 

International Animal Health Code. 

(Recommendations relating to 

Trichinellosis (Trichinella spiralis) 

appear in Part 2, Article 2.2.9.3 of the 

International Animal Health Code, 

2001.) The OIE Code provides that 

domestic swine in a country, or part of 

the territory of a country, may be 

considered free from trichinae based on 

the following factors: Trichinellosis in 

humans and animals must be reported; 

there is an effective disease reporting 

system in place that has proven to be 

capable of capturing the occurrence of 

cases; and it has been found that 

trichinae infection does not exist in the 

domestic swine population based on 

regular testing of a statistically 

significant sample of the population, or 

trichinellosis has not been reported in 5 

years and a surveillance program shows 

that the disease is absent from wild 

animal populations. 

As noted previously, the United 

States has an extremely low incidence 

of trichinae infection in swine. 

Although human trichinellosis is a 

reportable disease, the United States has 

no history of regular testing to 

determine trichinae infection in swine, 

nor do most States require the reporting 

of trichinae infection in swine when 

detected. Because a number of 

countries, such as those in the EU, 

require some form of testing for 

trichinae, implementing a trichinae 

control program in the United States 

would remove certain obstacles faced by 

exporters of U.S.-produced pork. One 

way to accomplish this goal within a 

reasonable timeframe would be to 

certify that herds were produced under 

the requirements of the Trichinae 

Certification Program and based on the 

use of good production practices that 

reduce, eliminate, or avoid the risk of 

exposure of swine to trichinae infection. 

Recent research efforts and pilot 

studies involving APHIS, FSIS, USDA’s 

Agricultural Marketing Service (AMS), 

Agricultural Research Service (ARS), 

and Cooperative State Research, 

Education, and Extension Service 

(CSREES), the National Pork Board, and 

other private industry and packer 

groups have led to the development of 

a program for certification of swine from 

pork production sites. Certification of 

swine as produced under the 

requirements of the Trichinae 

Certification Program is contingent on 

pork production sites following certain 

good production practices that reduce, 

eliminate, or avoid risk factors for the 

transmission of trichinae to swine, as 

well as systematic monitoring and 

testing of the product at the slaughter 

facility. The concept of risk 

management for control of Trichinella 

spiralis 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 

Veterinarians. 

A program for the certification of pork 

production sites that follow good 

production practices incorporates many 

of the principles of a Hazard Analysis 

and Critical Control Points or ‘‘HACCP’’

system. The specific hazard is the risk 

of exposure of swine to Trichinella 

spiralis. The critical control points in 

addressing this hazard, which are based 

on a number of studies on the 

epidemiology of trichinellosis and its 

transmission to domestic swine, focus 

on addressing those practices that 

potentially allow swine to ingest raw or 

undercooked meat waste products or 

rodents or animal carcasses that contain 

trichinae. The certification process in 

this type of program encompasses the 

following basic steps: 

• Accredited veterinarians trained in 

good production practices relative to 

exposure to trichinae work with 

producers to ensure that trichinae risk 

factors are reduced, eliminated, or 

avoided at pork production sites; 

• The site audit performed by trained 

USDA-accredited veterinarians serves as 

a method to document that risks of 

infection are eliminated or satisfactorily 

controlled. Audits need to be done 

periodically to ensure that good 

production practices relative to 

trichinae control remain in place; 

• On a regular basis, a statistically 

valid sample of the total number of 

swine from certified production sites is 

tested at the slaughter facility laboratory 

or some other onsite or offsite laboratory 

using licensed or accepted testing 

methods to verify the absence of 

trichinae infection; and 

• QVMOs perform random ‘‘spot 

audits’’ of certified production sites to 

ensure the overall integrity and 

consistency of the program. 

The regular site audit takes into 

account those management practices 

that affect the risk of exposure of swine 

to trichinae, such as feed integrity (i.e., 

source and storage), building 

construction and condition as it pertains 

to biosecurity, integrity of rodent 

control programs, and general 

management and hygiene factors as they 

pertain to rodent control, swine 

cannibalism, and other issues. As a part 

of the process of raising swine under 

good production practices, the producer 

needs to maintain certain records that 

document its adherence to good 

production practices, with those records 

being verified in the site audit. The 

producer also is responsible for 

adhering to good production practices 

between site audits. 

A pilot program for the certification of 

pork production sites as being produced 

under the requirements of the Trichinae 

Certification Program that involved the 

above-mentioned agencies of USDA, as 

well as private industry, was conducted 

in Iowa, Minnesota, and South Dakota 

in 1997 and 1998. The purpose of the 

pilot program was to evaluate a processverification system for the production of 

pork. An on-farm audit, consisting of 55 

questions, was developed to identify 

those risk factors that could expose 

swine to Trichinella spiralis. The audit 

was administered by USDA-trained 

accredited veterinary practitioners at 

198 pork production sites in the 3-State 

area. All swine raised on sites where 

audits were conducted were slaughtered 

at a single packing plant and a sample 

from each carcass was tested by the 

pooled sample digestion and ELISA 

methods. Few production sites met all 

criteria established within the audit for 

good production practices similar to 

those proposed in this document. Most 

of the deficiencies related to the absence 

of a regular rodent control program 

around and in swine production 

facilities. However, it was determined 

that more than 85 percent of these sites 

could meet good production practice 

criteria with minor improvements in 

site management. From a total of 

221,123 carcass samples tested from 

farms audited during a 6-month period, 

no trichinae-positive carcasses were 


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detected by digestion or ELISA 

methods. Based on the outcome of this 

pilot program, an improved, more 

succinct audit was developed with 

objective measures for those good 

production practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. This 

revised version of the site audit is 

currently being used in a second pilot 

program involving pork production sites 

located in Colorado, Illinois, Iowa, 

Minnesota, Missouri, Nebraska, 

Oklahoma, and South Dakota that are 

supplying swine to a slaughter facility 

in Iowa. 

This second pilot program began in 

December of 2000. Pork product sites 

were selected based on their willingness 

to participate in the program. As of 

December 2004, there were 

approximately 125 sites participating in 

the program. Program sites have 

completed one or more official pilot 

audits conducted by qualified 

accredited veterinarians that indicate 

the site is following certain good 

production practices designed to 

reduce, eliminate, or avoid the risk of 

exposure of swine to Trichinella 

spiralis. The slaughter facility in Iowa 

has conducted verification testing on 

swine carcasses from a statistically valid 

sample of the participating sites that 

have attained ‘‘certified’’ status. Close to 

100 accredited veterinarians have also 

been trained as site auditors during this 

period. 

The primary purpose of this second 

pilot program is to verify the adequacy 

of the selected good production 

practices in minimizing, reducing, or 

eliminating the risk of exposure of 

swine to Trichinae spiralis, as well as to 

confirm that the site audit and slaughter 

plant sample testing protocols provide a 

dependable means of verifying that good 

production practices are being followed. 

This second pilot program will continue 

until rulemaking establishes the 

Trichinae Certification Program. 

Collaboration with AMS and FSIS 

As previously stated, APHIS has 

collaborated with FSIS and AMS, 

among other entities, in developing a 

program for certification of swine from 

pork production sites. This 

collaboration included the research 

efforts of AMS as well as their 

continuing role in training laboratory 

technicians who work in slaughter 

facilities on how to conduct trichinae 

ELISA tests. FSIS has supported the 

trichinae program through its research 

efforts at the beginning of the pilot 

program and its direct participation in 

the program at federally inspected 

slaughter facilities. Moreover, in a 

proposed rule published in the Federal 

Register on February 27, 2001 (66 FR 

12590–12635), FSIS, in proposing to 

remove prescriptive trichinae treatment 

requirements in favor of performance 

standards, pointed to the program as 

one means by which establishments that 

produce pork products can ascertain 

whether their suppliers have taken 

measures to prevent trichinae infection 

of their herds. In that document, FSIS 

also discussed its role in verifying that 

processors properly check status of pigs, 

testing samples as required, and 

maintaining adequate animal 

identification and records under the 

program. Both AMS and FSIS have been 

important and willing partners in this 

pilot program, and we expect this 

collaboration to continue. 

As a result of the cooperative research 

efforts and pilot programs just 

referenced, we are proposing to 

establish regulations for a voluntary 

Trichinae Certification Program to 

appear as a new part 149 in 9 CFR 

subchapter G of the regulations. The 

current title of Subchapter G, ‘‘Poultry 

Improvement’’, would be changed to 

‘‘Livestock Improvement’’ to reflect that 

the subchapter’s regulatory coverage 

would now encompass animals other 

than poultry. The proposed Trichinae 

Certification Program would provide for 

the certification of pork production sites 

that follow certain prescribed 

management practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. In 

addition to establishing a new part 149, 

we also would make certain changes to 

existing regulations in 9 CFR parts 160 

and 161 covering the accreditation of 

veterinarians that are needed for this 

Trichinae Certification Program. The 

full text of the proposed regulations 

appears in the rule portion of this 

document. Our discussion of the 

proposed provisions follows. 

Purpose and Scope 

Proposed § 149.0 would provide that 

the Trichinae Certification Program 

described in part 149 is intended to 

enhance the ability of swine producers, 

as well as slaughter facilities and other 

persons that handle or process swine 

from pork production sites that have 

been certified under the program, to 

export fresh pork and pork products to 

overseas markets. We would include 

this statement in the regulations 

because, although we recognize that 

producers may wish to participate in the 

program for domestic marketing 

purposes, such uses would be outside 

the scope of APHIS’ authority. Any 

domestic marketing uses of the program, 

such as the labeling of products, would 

have to be conducted in accordance 

with the regulations of FSIS and AMS. 

Definitions 

Proposed § 149.1 would contain 

definitions for the terms used in part 

149. 

We would define an accredited 

veterinarian as a veterinarian approved 

by the APHIS Administrator in 

accordance with 9 CFR part 161 to 

perform functions specified in 9 CFR, 

chapter I, subchapters B, C, D, and G. 

The term Agricultural Marketing 

Service or AMS would refer to the 

Agricultural Marketing Service of the 

United States Department of 

Agriculture, while the AMS 

Administrator would refer to the 

Administrator, Agricultural Marketing 

Service, or any person authorized to act 

for the AMS Administrator. An AMS 

representative would be defined as any 

individual employed by or acting as an 

agent on behalf of the Agricultural 

Marketing Service who is authorized by 

the AMS Administrator to perform the 

services required by proposed part 149. 

The term Animal and Plant Health 

Inspection Service or APHIS would refer 

to the Animal and Plant Health 

Inspection Service of the United States 

Department of Agriculture. 

An animal disposal plan would be 

defined as a written document that 

describes methods for the removal and 

disposal of dead swine or swine remains 

from a pork production site, while an 

animal movement record would be 

defined as a written record of the 

movement of swine into or from a pork 

production site. 

The term APHIS Administrator refers 

to the Administrator, Animal and Plant 

Health Inspection Service, or any person 

authorized to act for the APHIS 

Administrator, while an APHIS 

representative would refer to any 

individual employed by or acting as an 

agent on behalf of the Animal and Plant 

Health Inspection Service who is 

authorized by the APHIS Administrator 

to perform the services required by 

proposed part 149. 

We would define an approved 

laboratory as a non-Federal laboratory 

approved by the Agricultural Marketing 

Service and recognized by the APHIS 

Administrator or FSIS Administrator for 

performing validated tests to determine 

the presence of trichinae infection in 

reference to the Trichinae Certification 

Program. 

The term audit would be defined as 

an inspection process, as provided in 

proposed part 149, that generates a 

written record documenting a pork 

production site’s adherence to the 

required good production practices. 


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1The labeling of all certified pork or pork 

products leaving a slaughter or processing facility 

must comply with 9 CFR 317.4 and all other 

applicable FSIS labeling regulations. 

There would be two types of audits, a 

site audit and a spot audit, both of 

which are defined below. An auditor 

would be defined as a qualified 

accredited veterinarian (QAV) or a 

qualified veterinary medical officer 

(QVMO) who is trained and authorized 

by APHIS to perform auditing activities 

under the Trichinae Certification 

Program. 

The term certification or certified 

would refer to the designation given by 

the APHIS Administrator to a pork 

production site that has been 

determined to be in compliance with 

the specific good production practices 

and other program requirements of the 

Trichinae Certification Program as 

provided in part 149. 

The term certified pork would refer to 

pork or pork products originating from 

certified swine from a certified 

production site with identity of such 

animals or carcasses maintained 

throughout receiving, handling, and 

processing.1

A certified production site would be 

defined as a pork production site that 

has attained a program status of Stage II 

or higher based on adherence to good 

production practices and other program 

requirements as provided in proposed 

part 149. 

The term certified swine would refer 

to swine produced under the Trichinae 

Certification Program on a certified 

production site. 

The term decertification or decertified 

would be defined as the removal of the 

certified status of a production site by 

the APHIS Administrator when it has 

been determined that the criteria of the 

Trichinae Certification Program are not 

being met or maintained. 

Enzyme-linked immunosorbent assay 

or ELISA would refer to a method of 

testing swine for the presence of 

trichinae infection by looking for 

antibodies to Trichinella spiralis in the 

sera, plasma, whole blood, tissue fluid, 

or meat juice of swine. 

The term EPA would refer to the 

United States Environmental Protection 

Agency. 

A feed mill quality assurance affidavit 

would be defined as a written statement 

signed by the feed mill representative 

and the producer that documents the 

quality and safety of feed or feed 

ingredients delivered from the feed mill 

to the pork production site. 

Food Safety and Inspection Service or 

FSIS would refer to the Food Safety and 

Inspection Service of the United States 

Department of Agriculture, while the 

FSIS Administrator would refer to the 

Administrator, Food Safety and 

Inspection Service, or any person 

authorized to act for the Administrator. 

An FSIS program employee would be 

defined as any individual employed by 

or acting as an agent on behalf of the 

Food Safety and Inspection Service who 

is authorized by the FSIS Administrator 

to perform the services required under 

proposed part 149. 

The term good manufacturing 

practices would be defined as feed 

manufacturing practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis, while 

the term good production practices 

would refer to pork production 

management practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. 

The term harborage would be defined 

as any object, debris, clutter, or area that 

could serve as shelter or refuge for 

rodents or wildlife. 

We would define a laboratory 

approval audit as an audit performed by 

AMS representatives to determine if a 

laboratory meets minimum 

requirements for approval, as 

established by AMS, for performing 

validated tests under proposed part 149. 

We would define National Trichinae 

Certified Herd as all swine raised on 

certified production sites in the United 

States. 

The term person would be defined as 

any individual, corporation, company, 

association, firm, partnership, society, 

joint stock company, or other legal 

entity. 

A pest control operator refers to a 

person trained and State-licensed in the 

control of pests and vermin (particularly 

rodents). 

Pooled sample digestion method or 

digestion method would refer to a 

method of testing swine for trichinae 

infection by identifying the presence of 

Trichinella spiralis from a sample of the 

animal’s muscle tissue. 

We would define a pork production 

site or site as a geographically definable 

area that includes pork production 

facilities and ancillary structures under 

common ownership or management 

systems and the surrounding space 

within a 100-foot perimeter of the swine 

housing and feeding areas. 

The term positive test result would 

mean the outcome of a validated test 

indicating the presence of Trichinella 

spiralis. 

The term process-verification testing 

would refer to the testing of a 

statistically valid sample of swine 

belonging to the National Trichinae 

Certified Herd at the time of slaughter 

using a validated test to verify that the 

adherence to good manufacturing 

practices and good production practices 

is resulting in the absence of Trichinella 

spiralis infection in swine from that 

herd. 

We would define a producer as an 

individual or entity that owns or 

controls the production or management 

of swine. 

A qualified accredited veterinarian or 

QAV would refer to an accredited 

veterinarian who has been granted an 

accreditation specialization by the 

APHIS Administrator pursuant to 9 CFR 

161.5 based on completion of an APHISapproved orientation or training 

program in good production practices in 

swine management, and who is 

authorized by the APHIS Administrator 

to perform site audits and other 

specified program services required in 

proposed part 149. A qualified 

veterinary medical officer or QVMO 

would refer to a VMO of the State or 

Federal Government who is trained in 

good production practices and is 

authorized by the APHIS Administrator 

to perform site audits, spot audits, and 

other specified program services 

required in proposed part 149. 

The term rodent control logbook 

would be defined as a written record 

that documents a rodent control 

program for a pork production site. 

We would define a site audit as an 

audit, performed by a QAV or a QVMO, 

to determine the trichinae risk factor 

status of a pork production site based on 

the site’s adherence to all of the 

required good production practices that 

reduce, eliminate, or avoid the risk of 

exposure of swine to Trichinella 

spiralis. 

The term slaughter facility would be 

defined as a slaughtering establishment 

operating under the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.) or 

a State meat inspection act that receives 

certified swine under the Trichinae 

Certification Program. 

We would define the term slaughter 

facility representative as any individual 

employed by, or acting as an agent on 

behalf of, a slaughter facility who is 

authorized by the slaughter facility to 

perform specified program services 

required in proposed part 149. 

A spot audit would refer to an audit 

of a certified pork production site 

performed by a QVMO to ensure 

program integrity and consistency. 

Pork production sites that are in the 

Trichinae Certification Program would 

be assigned a particular program status 

as either a Stage I enrolled site, a Stage 

II certified site, or a Stage III certified 

site. The term Stage I enrolled would 

refer to the preliminary program status 


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of a pork production site attained when 

the APHIS Administrator approves the 

outcome of an initial site audit. We 

would define the term Stage II certified 

as that program status attained upon 

APHIS approval of a site audit of a Stage 

I enrolled site, while the term Stage III 

certified would refer to program status 

attained upon APHIS approval of a site 

audit of a Stage II certified site and 

maintained upon APHIS approval of 

subsequent site audits for renewal of 

Stage III certified status. 

The term sterile zone would be 

defined as an open area immediately 

adjacent to and surrounding those 

building(s) used to house and feed 

swine that serves as both a buffer and 

detection zone for rodent and wildlife 

activity. 

The term temporary withdrawal 

would be defined as the voluntary 

withdrawal of a certified production site 

from the Trichinae Certification 

Program at the request of the producer 

for a period not to exceed 180 days. 

Trichinae would be defined as a 

generic term that refers to Trichinella 

spiralis. 

We would define Trichinae 

Certification Program or program as a 

voluntary pre-harvest pork safety 

program in which APHIS certifies pork 

production sites that follow all of the 

required good production practices that 

reduce, eliminate, or avoid the risk of 

exposure of swine from their sites to 

Trichinella spiralis. 

The Trichinae Identification Number 

or TIN would be a number assigned to 

a pork production site by the APHIS 

Administrator. 

We would define the term Trichinella 

spiralis as a parasitic nematode 

(roundworm) capable of infecting many 

warm-blooded carnivores and 

omnivores, including swine. 

The abbreviation USDA would refer 

to the United States Department of 

Agriculture. 

The term validated test would be 

defined as an analytical method 

licensed by APHIS or accepted by AMS 

for the diagnosis of Trichinella spiralis 

in swine. 

A veterinary medical officer or VMO 

would be defined as a veterinarian 

employed by the State or Federal 

Government who is authorized to 

perform official animal health activities 

on their behalf. 

We would define a waste feeding 

logbook as a written record that 

documents the presence of good 

production practices with respect to the 

feeding of meat-containing waste to 

swine and compliance with applicable 

State and Federal food waste feeding 

laws and regulations. 

Program Participation 

Proposed § 149.2 would provide 

information on producer participation 

in the trichinae certification program. A 

producer’s initial enrollment and 

continued participation in the program 

would require that the producer adhere 

to all of the required good production 

practices, as confirmed by periodic site 

audits, and comply with other 

recordkeeping and program 

requirements provided in proposed part 

149. Pork production sites accepted into 

the program by APHIS would 

participate under one of the following 

three program stages: Stage I enrolled, 

Stage II certified, or Stage III certified. 

Stage I Enrolled Status 

Under proposed § 149.2(a), attaining 

Stage I enrolled status would signify 

that a pork production site has met all 

of the required good production 

practices and other recordkeeping and 

program requirements provided in part 

149. Although enrolled in the program, 

Stage I enrolled sites would not be able 

to identify their swine as products from 

a certified production site. If a Stage I 

enrolled site is found not to be adhering 

to one or more good production 

practices as a result of a site audit or a 

spot audit, or fails to follow the 

prescribed timetable for completing a 

site audit and submitting the completed 

audit form and payment for 

consideration as a Stage II certified site, 

it would lose its status as a Stage I 

enrolled site. As provided in § 149.3(d), 

the site audit must be performed no 

sooner than 150 days from the date the 

site was awarded Stage I enrolled status, 

and must be completed, with the audit 

form and payment submitted to APHIS, 

no later than 210 days from the date the 

site was awarded Stage I enrolled status. 

Stage II Certified Status 

Under proposed § 149.2(b), attaining 

Stage II certified status would signify 

that a pork production site is adhering 

to all of the required good production 

practices and complies with other 

recordkeeping and program 

requirements provided in part 149. An 

APHIS-issued certificate or letter 

indicating the site’s status as a Stage II 

certified site would have to be filed at 

the site and be readily available for 

inspection. Once a site attains Stage II 

certified status, it would then be able to 

identify its swine as certified product 

from a certified production site. 

A Stage II certified site that is found 

not to be adhering to one or more good 

production practices as a result of a site 

audit or a spot audit, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment 

for consideration as a Stage III certified 

site, would be decertified by APHIS and 

would be ineligible to identify swine 

from that site as certified product from 

a certified production site. As provided 

in § 149.3(e), a Stage II certified site 

must complete a site audit for Stage III 

certified status. Under § 149.3(e), the 

site audit must be performed no sooner 

than 240 days from the date the site was 

awarded Stage II certified status, and 

must be completed, with the audit form 

and payment submitted to APHIS, no 

later than 300 days from the date the 

site was awarded Stage II certified 

status. As further provided in § 149.2(e), 

once a site is decertified, the producer 

would have to repeat the process of 

requesting a new site audit for Stage I 

enrolled status. If a decertified site is 

reenrolled after a successful Stage I site 

audit, then a new program anniversary 

date for that site would be established 

based on the date of enrollment and the 

site would be reinstated at Stage II 

status. 

Stage III Certified Status 

Proposed § 149.2(c) would cover sites 

attaining Stage III certified status. The 

primary distinction between Stage II 

and Stage III certified sites would be 

that once a site is awarded Stage III 

certified status, it would not be required 

to undergo another site audit for 

recertification for another 14 to 16 

months. In contrast, a Stage II certified 

site would have to undergo another site 

audit 8 to 10 months after it receives its 

Stage II certification. We would allow a 

longer period to elapse between site 

audits for Stage III sites based on their 

record of already successfully 

completing site audits at the Stage I and 

Stage II program levels. All other 

aspects of Stage III certification would 

be the same as described above in the 

discussion of Stage II certification. 

Change in Ownership 

Proposed § 149.2(d) would provide 

the steps to be taken in the event there 

is a change of ownership in a site 

participating in the program. If there is 

a change in ownership in a Stage I 

enrolled site, and the new ownership 

wishes to remain in the program, then 

the Stage I enrolled site would continue 

on the same timetable as under the 

previous ownership for completing a 

site audit for Stage II certified status. No 

additional site audit would be required 

as a result of the change of ownership 

since another site audit would occur 

anyway within 6 months or less if the 

site intends to remain in the program. 


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If there is a change of ownership in a 

Stage II or Stage III certified site, 

however, we would require that a site 

audit be performed within 60 days of 

the ownership change in order for the 

site to maintain its certified status. If the 

site audit is satisfactory, then the Stage 

II or Stage III certified site would 

continue in the program only as a Stage 

II certified site. We would require a 

Stage III certified site to revert to Stage 

II certified status after a change in 

ownership so that the site would have 

another site audit within 1 year’s time. 

This would provide us with greater 

assurances that the new ownership is 

adhering to the good production 

practices. A new program anniversary 

date for purposes of performing future 

audits would be established based on 

the date the site was audited to continue 

in the program as a Stage II certified 

site. 

If the results of a site audit following 

a change in ownership are not 

satisfactory, then the site would be 

decertified by APHIS. Should the 

producer wish to participate in the 

program once again, he or she would 

have to request a new site audit for 

Stage I enrolled status once the 

particular deficiencies have been 

resolved. If a site is decertified by 

APHIS, but is reenrolled after a 

successful Stage I site audit, then a new 

program anniversary date for the site 

would be established based on the date 

of reenrollment. 

Site Decertification and Program 

Withdrawal 

Proposed § 149.2(e) would cover site 

decertification by APHIS, as well as 

voluntary site decertification and 

voluntary program withdrawal initiated 

by the producer. 

Decertification by APHIS 

In proposed § 149.2(e)(1), a Stage II or 

Stage III certified site that is found not 

to be adhering to one or more good 

production practices as a result of a site 

audit or a spot audit, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment 

to continue participation in the 

program, would be decertified by 

APHIS. Once a site is decertified, swine 

from that site could not be identified as 

certified product from a certified 

production site. In order to participate 

in the program once again, the producer 

would have to follow the procedures for 

requesting an initial site audit for Stage 

I enrolled status. If a decertified site is 

reenrolled after a successful Stage II site 

audit, then a new program anniversary 

date for that site would be established 

based on the date of reenrollment. 

Temporary Withdrawal by Producer 

Proposed § 149.2(e)(2) would provide 

that a producer may request that one or 

more of their certified production sites 

be temporarily withdrawn from the 

program. A producer might choose this 

option because he or she foresees not 

having access to animals from certified 

sources on a temporary basis. A 

producer’s request to have a site 

temporarily withdrawn would have to 

be made in writing and would be 

subject to the APHIS Administrator’s 

approval. Each site could be temporarily 

withdrawn no more than once every 2 

years for a period not to exceed 180 

days. 

While a site is temporarily 

withdrawn, the producer could not 

identify swine from that site as certified 

product from a certified production site. 

However, the producer would still have 

to adhere to all good production 

practices and other program 

requirements while the site is 

temporarily withdrawn, unless 

specifically waived by the 

Administrator. This would include 

providing documentation in the animal 

movement record of the arrival and 

departure of all swine from the site, as 

well as whether the swine arriving at 

the site are from certified or noncertified 

sources. 

Before being reinstated as a certified 

production site, the temporarily 

withdrawn site would have to pass a 

site audit to indicate that it is adhering 

to all good production practices 

(including any practices previously 

waived by the Administrator). If swine 

5 weeks of age or older originating from 

noncertified sources are received at the 

site during the time of withdrawal, then 

the site audit would have to be 

performed within 30 days of the date 

the last swine from noncertified sources 

was removed from the site, but no later 

than 180 days from the date the site was 

granted temporarily withdrawn status. If 

the site audit is satisfactory and it is 

determined that the site is adhering to 

good production practices and other 

program requirements, then the site 

would be reinstated as a Stage II 

certified site (regardless of the site’s 

previous status as a Stage II or Stage III 

certified site). The timetable for 

performing future site audits for 

attaining and renewing Stage III 

certified status would be based on the 

date the site was reinstated as a Stage II 

certified site. 

If the site audit for reinstatement as a 

certified production site is not 

satisfactory due to the producer’s failure 

to adhere to one or more good 

production practices, or if the period of 

temporary withdrawal has exceeded 180 

days, then the site would be decertified 

by APHIS. Once the site is withdrawn 

by APHIS, the producer would have to 

request an initial site audit for Stage I 

enrolled status in order for the site to be 

reenrolled in the program. If a site is 

withdrawn by APHIS and then 

reenrolled after a successful Stage I site 

audit, then a new program anniversary 

date for that site would be established 

based on the date of reenrollment as a 

Stage I enrolled site. 

Program Withdrawal 

Under proposed § 149.2(e)(3), if a 

producer decides to withdraw one or 

more pork production sites from the 

program, then the producer would have 

to notify the APHIS Administrator in 

writing of this intent. Once this is done, 

the site would be removed from the 

program. If at a later date the producer 

requests that the site be reinstated in the 

program, then the producer would have 

to follow the procedures for requesting 

an initial audit for Stage I enrolled 

status. If the site is reenrolled after a 

successful Stage I site audit, then a new 

program anniversary date for that site 

would be established based on the date 

of reenrollment. 

Request for Review 

Under proposed § 149.2(f), if there is 

a conflict as to any material fact relating 

to the results of a site audit, spot audit, 

or other determination affecting a 

producer’s program status or ability to 

participate in the program, the producer 

may submit a written request for review 

to the APHIS Administrator. The 

producer would have to include in the 

request the reasons, including any 

supporting documentation, why the 

audit result or other determination 

should be different than the result or 

determination made by the 

Administrator. The initial audit result or 

other determination would remain in 

force pending the completion of the 

Administrator’s review. The decision by 

the Administrator upon reviewing the 

producer’s written request would be 

final. 

Site Audit 

Proposed § 149.3 would contain more 

specific information on performing site 

audits. Proposed § 149.3 also would 

describe all of the required good 

production practices that would be the 

primary basis for determining whether a 

site can participate in the program. 


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2FSIS and AMS would not charge any additional 

program fees for the site audit, however, FSIS does 

charge $15 for export certificates. 

General 

Proposed § 149.3(a) would set forth 

the procedures for arranging and 

performing a site audit, as well as the 

process for providing notification of the 

audit results. This paragraph would 

apply to sites seeking status as a Stage 

I enrolled or a Stage II certified site, as 

well as sites seeking or renewing their 

status as a Stage III certified site. 

The producer would be responsible 

for contacting a QAV to request a site 

audit. A list of available QAVs could be 

obtained by accessing the Trichinae 

Certification Program Web site on the 

Internet at http://www.aphis.usda.gov/ 

vs/trichinae, or by contacting the APHIS 

area office. Telephone numbers for 

APHIS area offices can be found in local 

telephone books or on the Internet at 

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

area_offices.htm. If a QAV is not 

available to perform a site audit, the 

producer could then contact the APHIS 

area office to request that a QVMO 

perform the site audit. The site audit 

would be arranged at a mutually agreedupon time. We also would require that 

the producer or the producer’s 

designated representative accompany 

the auditor during the site audit. 

While performing the site audit, the 

auditor would record whether the 

producer is adhering to good production 

practices at the site, as discussed below 

in proposed § 149.3(b), that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. In 

performing the site audit, the auditor 

would use APHIS-approved audit forms. 

Once the auditor has completed all 

sections of the audit form, the producer 

or the producer’s designated 

representative would have to sign the 

audit form attesting to the accuracy of 

the information obtained during the site 

audit. The producer’s signature also 

would evidence his or her intent to 

continue adhering to the good 

production practices and other program 

requirements. The auditor also would 

sign the audit form at this time. 

The producer would be responsible 

for the cost of each site audit performed 

at the pork production site. If a QAV 

performs the site audit, then the 

producer would pay the QAV directly at 

a mutually agreed-upon time and rate. If 

a QVMO performs the site audit, then 

the producer would pay the QVMO at 

the time the site audit is performed in 

accordance with the rate and other 

conditions set by the QVMO’s 

governmental employer. In the case of a 

site audit performed by a QVMO 

employed by APHIS, the producer 

would pay APHIS by certified check or 

U.S. money order for this service at a 

rate determined in accordance with 

proposed § 149.8. 

In addition to the cost of the site 

audit, the producer also would have to 

pay a separate fee, as specified in 

proposed § 149.8, to cover APHIS’

administrative costs in processing the 

audit and operating the program. We are 

proposing a program fee of $51, payable 

to APHIS by certified check or U.S. 

money order, to be remitted to the 

auditor at the time each site audit is 

performed. To arrive at the program fee 

of $51, APHIS examined costs 

associated with the pilot program and 

itemized those costs based on 127 

applications processed during the pilot 

program.2

The basic steps in the calculation for 

each particular service are: (1) Calculate 

direct labor costs by determining the 

average amount of direct labor required 

to perform the service and multiply the 

average direct labor hours by the 

average salary and benefit costs for 

employees; (2) calculate the pro rata 

share of administrative support costs; 

(3) determine the premium costs (if 

any); (4) calculate the pro rata share of 

agency overhead and departmental 

charges, respectively, including the 

salary of the National Coordinator; (5) 

add all costs; and (6) round up to the 

next $0.25 for all fees less than $10 or 

round up or down to the nearest dollar 

for all fees greater than $10. Table 1 

below shows how APHIS arrived at this 

rate. 

TABLE 1.—COSTS CONSIDERED IN ARRIVING AT THE $51 PROGRAM FEE

[Based on 127 applications processed] 

Number of 

hours 

Hourly salary (FY 05) Benefits 

@24.26% 

Direct labor 

costs 

Direct Labor: 

Area Epidemiology Officer 2 ...................................................................................... 13.23 $42.55 $10.32 $699.58 

Clerk 3 ....................................................................................................................... 71.44 16.29 3.95 1,445.77 

Inspector 4 ................................................................................................................. 25.40 29.63 7.19 935.18 

Total direct labor costs ...................................................................................... .................... .................... .................... 3,080.53 

Support costs at 62.31% .......................................................................................... .................... .................... .................... 1,919.47 

Subtotal ............................................................................................................. .................... .................... .................... 5,000.00 

Agency overhead at 16.15% .................................................................................... .................... .................... .................... 807.50 

Subtotal ............................................................................................................. .................... .................... .................... 5,807.50 

Departmental charges at 4.57% ............................................................................... .................... .................... .................... 265.40 

Subtotal ............................................................................................................. .................... .................... .................... 6,072.90 

Reserve component ................................................................................................. .................... .................... .................... 303.64 

Total full cost for processing 127 applications .................................................. .................... .................... .................... 6,376.54 

Full cost per application ........................................................................................... .................... .................... .................... 50.21 

Full cost per application, rounded up to the nearest whole dollar ........................... .................... .................... .................... $51.00 

2 Includes time to review the application, compare to standards, identify any nonconformities, call the auditor (if necessary), approve/deny application, and sign. 3GS 5/step 5 clerk (includes time to process and file paperwork, identify auditing veterinarian, and perform data entry). 

4GS 11/step 5 inspector (includes time for spot audits). 


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The auditor will submit the 

completed audit form, program fee, and 

payment for services (if the auditor was 

an APHIS-employed QVMO) to the 

nearest APHIS area office. If a QAV 

performs the site audit rather than a 

QVMO, the QAV will submit the 

completed audit form and program fee 

to APHIS in a timely manner. 

Upon receipt of the completed audit 

form and payment, APHIS would 

evaluate the site audit and provide the 

producer with written notification of the 

audit results. A pork production site 

found to meet all good production 

practices and other program 

requirements would be issued program 

status at the appropriate program stage. 

If the audit shows that the site does not 

meet all good production practices or 

other program requirements, APHIS 

would provide the producer with 

written notification that would include 

documentation of the deficiencies that 

prevented the site from being conferred 

program status. It would be the 

producer’s responsibility to work with a 

veterinarian or other consultants to 

correct those deficiencies should the 

producer seek to enroll in the program 

at a later time. 

Good Production Practices 

Proposed § 149.3(b) would set forth 

all of the required good production 

practices that producers would have to 

adhere to in order to participate in the 

program. As discussed previously, these 

good production practices are designed 

to reduce, eliminate, or avoid those risk 

factors involving the exposure of swine 

to Trichinella spiralis. The good 

production practices would be as 

follows: 

• The movement of all non-breeding 

swine 5 weeks of age or older into or 

from the pork production site would 

have to be documented in an animal 

movement record, as provided in 

proposed § 149.7, that ensures that all 

such swine moved into or from the site 

can be subsequently traced back to that 

site, or to any previous site (if 

applicable). Additional information 

relating to the animal movement record 

is provided below under the heading 

‘‘Recordkeeping at Site.’’

• All non-breeding swine entering a 

site would have to have originated from 

another certified production site, except 

that non-breeding swine less than 5 

weeks of age may have originated from 

a certified or noncertified production 

site. We would provide this exception 

because swine less than 5 weeks of age 

do not as yet eat solid food, and 

therefore do not present a risk of 

ingesting the Trichinella spiralis 

parasite through infected food sources. 

The animal movement record would 

have to include the TIN of the certified 

production site from which the swine 

originated. If the swine are less than 5 

weeks of age and come from a 

noncertified site, then the animal 

movement record would have to 

provide the name and full address of the 

noncertified site where the swine 

originated. 

• Feed or feed ingredients from offsite 

sources that are used at the site would 

have to meet all good manufacturing 

practices or other quality assurance 

standards recognized by the feed 

industry. The adherence to good 

manufacturing practices or other quality 

assurance standards would have to be 

documented in a feed mill quality 

assurance affidavit. Additional 

information relating to the feed mill 

quality assurance affidavit is provided 

below under the heading 

‘‘Recordkeeping at Site.’’

• Swine housing and feeding areas, 

feed preparation and storage areas, and 

office areas and connecting hallways at 

the site would have to be inspected 

regularly and found free of fresh signs 

of rodent and wildlife activity. Any 

movable rodent harborage (exterior or 

interior) on the site that is not necessary 

to the day-to-day operation of the site 

would have to be removed. Harborage 

that cannot be removed or is movable 

but necessary to the day-to-day 

operation of the site (e.g., bales of hay, 

etc.) would have to be checked for signs 

of rodent or wildlife activity. In 

addition, domesticated animals, 

including pets such as dogs and cats, 

would have to be excluded from the 

swine housing and feeding areas and 

feed preparation and storage areas at the 

site. Evidence of rodent activity or 

rodent infestation would consist of fresh 

rodent droppings, fresh gnawing marks, 

new structural damage, rodent urine, 

rodent blood, rodent smear marks (body 

oil), rodent tracks, or recent burrowing 

or burrow use. Evidence of wildlife 

activity would consist of wildlife feces, 

footprints, fur, or hair observed in or 

near the stored feed or feed ingredients, 

dead or live wildlife observed in or near 

the stored feed or feed ingredients, or 

wildlife burrows or nests observed in or 

near the stored feed or feed ingredients. 

Exterior rodent bait stations and/or traps 

would have to be placed around the 

perimeter of those building(s) housing 

the swine, as well as around the 

perimeter of outdoor swine feeding 

areas. Exterior rodent bait stations and/ 

or traps also would have to be placed 

around areas of potential rodent entry 

into building(s) used to house and feed 

swine (i.e., doorways, vent openings, 

loading chutes, cool cells, etc.). Interior 

rodent bait stations and/or traps would 

have to be placed near high-risk rodent 

zones such as entryways, hallways, 

office areas, swine load out areas, vents, 

cool cells, storage areas, utility rooms, 

cabinets, locker rooms, bathrooms, and 

break rooms. Interior rodent bait 

stations and/or traps would have to 

placed so that swine would not come in 

contact with the bait or trap. Rodent bait 

stations and/or traps also would need to 

be placed near exterior or interior 

harborage on the site that cannot be 

removed or that is movable but 

necessary to the day-to-day operation of 

the site. In all instances, rodent bait 

stations would have to be intact, 

systematically maintained, and contain 

fresh bait that consists of an EPAregistered rodenticide formulation that 

is applied according to its label. In 

addition, a sterile zone would have to be 

maintained around the perimeter of 

those building(s) used to house and feed 

swine. The sterile zone would have to 

be devoid of harborage or feed or water 

sources that could attract rodents or 

wildlife, but would have to contain 

rodent bait stations and/or rodent traps. 

The sterile zone also would have to be 

devoid of any vegetation unless it is 

decorative vegetation that is well 

maintained (i.e., residential height grass, 

flowers, shrubs, or trees). A sterile zone 

with decorative vegetation would 

require increased rodent control 

measures. The producer would need to 

provide documentation of rodent 

control practices, as described above, by 

maintaining at the site an up-to-date 

rodent control logbook with a site 

diagram and other recordkeeping 

evidencing implementation of rodent 

control measures, which could include 

documents provided by a pest control 

operator, as provided in proposed 

§ 149.7. Additional information relating 

to the rodent control logbook is 

provided below under the heading 

‘‘Recordkeeping at Site.’’

• Feed or feed ingredients stored at 

the site would have to be prepared, 

maintained, and handled in a manner 

that protects the feed or feed ingredients 

from possible exposure to or 

contamination by rodents or wildlife. 

Any movable harborage in the 

immediate vicinity of feed production 

and feed storage areas that is not 

necessary to the day-to-day operation of 

the site would have to be removed. 

Harborage that cannot be removed or 

harborage that is movable but necessary 

to the day-to-day operation of the site 

(e.g., bales of hay, etc.) would have to 

be checked for signs of rodent or 

wildlife activity. Rodent bait stations 

and/or traps would need to be placed 


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around (and in, if applicable) all feed 

preparation and storage areas, as well 

near any harborage in the vicinity that 

cannot be removed or that is movable 

but necessary to the day-to-day 

operation of the site. Rodent bait 

stations would have to be intact, 

systematically maintained, and contain 

fresh bait that consists of an EPAregistered rodenticide formulation that 

is applied according to its label. In 

addition, feed or feed ingredients that 

are stored in paper bags would have to 

be elevated off the floor and be a 

sufficient distance away from the walls 

to allow for inspection, baiting, and/or 

trapping. The rodent control logbook, as 

provided in § 149.7, would have to 

document that adequate rodent control 

procedures have been implemented in 

the feed production and feed storage 

areas. 

• Swine could not have access to 

wildlife harborage or dead or live 

wildlife at the site. Wildlife harborage 

would include wood or wooded lots and 

other natural areas where wildlife 

would have access. Dead or live wildlife 

could not be intentionally fed to swine. 

• If meat-containing waste is fed to 

swine at the site, then the producer 

would have to hold a license or permit 

that authorizes the feeding of such 

waste. Cooking times and temperatures 

of meat-containing waste to be fed to 

swine would have to be consistent with 

applicable State and Federal laws and 

regulations. In addition, up-to-date 

records of waste feeding and cooking 

practices, in the form of a waste feeding 

logbook provided for in proposed 

§ 149.7, would have to be maintained at 

the site. Cooked food waste products 

that are stored prior to feeding could not 

be mixed or contaminated with 

uncooked or undercooked meat waste 

material. Household food waste, 

regardless of whether it contains meat or 

is cooked or undercooked, also could 

not be fed to swine. We include this last 

requirement as another measure to 

prevent the attraction of rodents or 

wildlife to the site. Additional 

information relating to the waste feeding 

logbook is provided below under the 

heading ‘‘Recordkeeping at Site.’’

(The Swine Health Protection Act 

[SHPA, 7 U.S.C. 3801–3813] was 

enacted in 1980 to prevent the 

introduction of foreign animal diseases 

to U.S. domestic swine populations as a 

result of being fed raw or improperly 

treated food waste of animal origin. 

APHIS’ regulations promulgated under 

the SHPA in 9 CFR part 166 require the 

following: Persons must have a license 

to feed waste materials, food waste 

products must undergo proper heat 

treatment prior to being fed to swine, 

facilities and animals are subject to 

periodic inspection, and records must 

be maintained with respect to the 

removal of all treated and untreated 

garbage from the licensee’s premises. 

The Federal laws and regulations 

establish a minimum set of standards to 

be followed. States are free to set more 

stringent standards [which a number of 

States have done], including the 

prohibition of feeding of food waste 

materials to swine altogether.) 

• The site would need to have in 

place procedures that are carried out 

with regard to the prompt removal and 

proper disposal of dead swine and 

swine remains found in pens. We would 

require this practice to eliminate the 

opportunity for cannibalism among 

swine, as well as to prevent the 

attraction of rodents or wildlife. Such 

procedures would have to be 

documented in the animal disposal 

plan, as provided in proposed § 149.7. 

Additional information relating to the 

animal disposal plan is provided below 

under the heading ‘‘Recordkeeping at 

Site.’’

• General hygiene and sanitation of 

the pork production site would have to 

be maintained at all times to prevent the 

attraction of rodents and wildlife. We 

would require that solid non-fecal waste 

(facility refuse) be placed in covered 

receptacles and be regularly removed 

from the site. We also would require 

that spilled feed be regularly removed 

and properly disposed of. 

• All records required under 

proposed § 149.7 would have to be kept 

up-to-date and readily available for 

inspection at the site. Additional 

information relating to producer 

recordkeeping requirements is provided 

below under the heading 

‘‘Recordkeeping at Site.’’

Initial Site Audit for Stage I Enrolled 

Status 

Proposed § 149.3(c) would cover the 

steps for producers seeking to enroll 

their pork production site in the 

program. Interested producers should 

first request and review a pre-audit 

information packet prepared by APHIS 

that discusses the program, as well as 

the steps in preparing for and requesting 

an initial site audit. The pre-audit 

information packet could be obtained 

from a QAV, State or Federal animal 

health offices, or the National Pork 

Board, or by writing to: USDA, APHIS, 

Veterinary Services, Trichinae 

Certification Program, 210 Walnut St., 

Room 891, Des Moines, IA 50309. 

When the producer and the 

producer’s herd health personnel 

believe that the site meets program 

standards, the producer then should 

arrange for an initial site audit, as 

discussed above under proposed 

§ 149.3(a). Upon completion of the 

initial site audit and submission of the 

completed audit form and payment, 

APHIS would make a determination as 

to program enrollment within 30 days of 

receipt of the audit form. A pork 

production site that is found to meet all 

good production practices and other 

program requirements would be 

awarded Stage I enrolled status. 

Site Audit for Stage II Certified Status 

Proposed § 149.3(d) would cover the 

steps for a Stage I enrolled site to 

advance in the program as a Stage II 

certified site. The site audit would have 

to be performed no sooner than 150 

days (i.e., approximately 5 months) from 

the date the site was awarded Stage I 

enrolled status, and would have to be 

completed, with the audit form and 

payment submitted to APHIS, no later 

than 210 days (i.e., approximately 7 

months) from the date the site was 

awarded Stage I enrolled status. APHIS 

would make a determination on 

whether to certify the site within 7 days 

of receiving the completed audit form 

and payment. We would provide this 

expedited review for sites seeking status 

as Stage II certified sites so that 

producers could start identifying their 

animals as certified swine, assuming 

that the Stage I enrolled site is found to 

meet all good production practices and 

other program requirements and is 

awarded Stage II certified status. 

A Stage I enrolled site that is found 

during a site audit not to be adhering to 

one or more good production practices, 

or that fails to follow the prescribed 

timetable for completing a site audit and 

submitting the completed audit form 

and payment, would not be awarded 

Stage II certified status and would lose 

its program status as a Stage I enrolled 

site. 

Site Audit for Stage III Certified Status 

Proposed § 149.3(e) would cover the 

steps for a Stage II certified site to 

advance to Stage III certified site status. 

The site audit would have to be 

performed no sooner than 240 days (i.e., 

approximately 8 months) from the date 

the site was awarded Stage II certified 

status, and would have to be completed, 

with the audit form and payment 

submitted to APHIS, no later than 300 

days (i.e., approximately 10 months) 

from the date the site was awarded 

Stage II certified status. APHIS would 

review the completed audit form and 

make a determination as to Stage III 

certified status within 30 days of receipt 

of the audit form and payment. 


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A Stage II certified site that is found 

to meet all good production practices 

and other program requirements would 

be awarded Stage III certified status. If 

a Stage II certified site is found during 

a site audit not to be adhering to one or 

more good production practices, or fails 

to follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment, 

then the site would be subject to 

decertification by APHIS as provided in 

proposed § 149.2(e). 

Site Audit for Renewal of Stage III 

Certified Status 

Proposed § 149.3(f) would cover the 

steps for Stage III certified sites seeking 

to renew their program status as a Stage 

III site. The site audit would have to be 

performed no sooner than 14 months 

from the date the site was awarded 

Stage III certified status or the date that 

status was last renewed, and would 

have to be completed, with the audit 

form and payment submitted to APHIS, 

no later than 16 months from either the 

date the site was awarded Stage III 

certified status or the date that status 

was last renewed. APHIS would review 

the completed audit form and make a 

determination as to the site’s continued 

status as a Stage III certified site within 

30 days of receipt of the audit form and 

payment. 

A Stage III certified site that is found 

to meet all good production practices 

and other program requirements would 

have its status as a Stage III certified site 

renewed. If a Stage III certified site is 

found during a site audit not to be 

adhering to one or more good 

production practices, or fails to follow 

the prescribed timetable for completing 

a site audit and submitting the 

completed audit form and payment, 

then the site would be subject to 

decertification by APHIS as provided in 

proposed § 149.2(e). 

Spot Audit 

In addition to regularly scheduled site 

audits, certified production sites also 

would be subject to spot audits. Spot 

audits, including random spot audit and 

spot audits for cause, would be covered 

in proposed § 149.4. 

The APHIS Administrator would 

select certified production sites at 

random for a spot audit in order to: 

• Ensure the integrity of the auditing 

process; 

• Verify that the audit process is 

performed in a consistent manner across 

the program; and 

• Verify that all required good 

production practices are being 

maintained between regularly 

scheduled site audits. 

A certified production site also could 

be subject to a spot audit for cause to 

trace back and investigate any positive 

test results based on testing of certified 

swine from that site at the slaughter 

facility. 

All spot audits would be performed 

by a QVMO at no cost to the producer. 

APHIS would provide the producer 

with written notification of the results 

of the spot audit, including 

documentation of any deficiencies 

noted during the audit. If the site is 

found not to be adhering to one or more 

good production practices, then the site 

would be subject to decertification by 

APHIS as provided in proposed 

§ 149.2(e). 

Offsite Identification and Segregation of 

Certified Swine 

Under proposed § 149.5, certified 

swine moved from the certified 

production site to another location, 

whether to another certified production 

site, buying station, collection point, or 

slaughter facility, would have to remain 

segregated from noncertified swine at all 

times, and otherwise maintain their 

identity as certified swine in such a way 

that they could be readily traced back to 

the certified production site from which 

they came. Information relating to the 

identification of the certified swine 

would have to be documented in the 

animal movement record maintained by 

the producer. Failure to properly 

segregate or maintain the identity of 

certified swine from noncertified swine 

after leaving the certified production 

site would result in the loss of certified 

status for that shipment of swine. We 

would leave it up to producers or other 

handlers to determine how they wish to 

segregate the certified swine and 

otherwise maintain their identity as 

certified swine throughout the 

marketing process. 

Slaughter Facilities 

Proposed § 149.6 would cover the 

program responsibilities of participating 

slaughter facilities in regard to the 

verification, segregation, testing, and 

recordkeeping of swine from certified 

production sites. Participating slaughter 

facilities that fail to comply with any of 

the applicable requirements of § 149.6 

would not be allowed to continue 

participating in the program and no 

pork or pork products will be issued a 

certificate of export that identifies the 

product as being from the Trichinae 

Certification Program unless all 

requirements of this section are 

followed. This would not preclude, 

however, FSIS from issuing an export 

certificate for those products if they 

were to be instead sent to a country that 

did not require certifications with 

respect to trichinae or if the products 

were subsequently frozen in order to 

meet an importing country’s 

requirements in that way. FSIS would 

provide general oversight to verify that 

these functions are being carried out 

properly, while AMS would specifically 

oversee the laboratory approval and 

ongoing performance of laboratories that 

perform process-verification testing 

under this program. FSIS would issue 

instructions to slaughter facilities 

relating to program requirements at the 

time any final rule implementing the 

program described in this proposed rule 

is published. Further information with 

regard to laboratory approval 

requirements would be available from 

AMS as discussed under ‘‘ProcessVerification Testing of Certified Swine.’’

Verification of Certification 

Proposed § 149.6(a) would require 

that a slaughter facility receiving 

certified swine verify the current 

certification status of the pork 

production site from which the animals 

came. The slaughter facility could verify 

the current certification status of 

individual sites by maintaining dated 

certification documentation on file. The 

current certification status of individual 

sites also would be available on the 

Trichinae Certification Program Web 

site on the Internet at http:// 

www.aphis.usda.gov/vs/trichinae. If the 

slaughter facility is unable to verify a 

site’s certification status through 

documentation on file or through the 

program Web site, the slaughter facility 

then should contact the APHIS area 

office in the State where the site is 

located. 

Maintaining Identity and Segregation of 

Certified Swine and Pork Products 

Proposed § 149.6(b) would require 

that in order for a slaughter facility to 

identify product as certified pork, the 

certified swine and edible pork products 

derived from certified swine would 

have to remain segregated from swine 

and edible pork products from 

noncertified sites throughout receiving, 

handling, and processing at the facility, 

as well as while awaiting shipment from 

the facility. The slaughter facility also 

would have to maintain the identity of 

the certified swine or pork in a manner 

that would allow the swine or pork to 

be traced back to the certified 

production site from which it came. A 

slaughter facility’s failure to properly 

segregate or maintain the identity of 

certified swine and edible pork products 

derived from the certified swine would 

result in the loss of certified status for 

that shipment of swine, as well as the 


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edible pork products derived from those 

animals. It would be up to the slaughter 

facility to determine how it wishes to 

segregate and properly maintain the 

identity of certified swine and edible 

pork products derived from certified 

swine in its control. It is recommended 

that certified swine be processed in 

groups either at the beginning or at the 

end of the day or on separate days from 

noncertified animals. 

Process-Verification Testing of Certified 

Swine 

Proposed § 149.6(c) would require 

slaughter facilities handling and 

processing certified swine from certified 

production sites to carry out processverification testing at their expense in 

order to determine the Trichinella 

spiralis infection status of those 

animals. Under proposed § 149.6(c)(1), 

process-verification testing would have 

to be performed by using a validated 

test. This would include any test 

licensed by APHIS, such as those using 

the ELISA method, or otherwise 

accepted by AMS, such as the pooled 

sample digestion method. A copy of the 

testing methods and checklist for 

conducting validated tests would be 

available by contacting the Trichinae 

Program Manager, USDA, AMS, Science 

and Technology, Technical Services 

Branch, 1400 Independence Avenue 

SW., Mail Stop 0272, Washington, DC 

20250–0272; or by telephone at (202) 

690–0621. 

In proposed § 149.6(c)(2) we would 

require that such testing be performed 

in an approved laboratory that has been 

approved for trichinae testing by AMS. 

In addition to providing services 

relating to initial laboratory approval, 

AMS would monitor the ongoing 

performance and proficiency of 

laboratories that perform processverification testing under the program. 

The approved laboratory could be 

maintained and operated by the 

slaughter facility or by another business 

entity either on the premises of the 

slaughter facility or at another location. 

We would require that the laboratory 

staff performing the process-verification 

testing be approved by AMS. Once 

approved, laboratory staff performing 

this particular testing function would be 

subject to periodic proficiency test 

panels from AMS that would have to be 

analyzed correctly in order to maintain 

their approved status. This periodic 

proficiency testing would be done for 

purposes of quality assurance. Further 

information on approved laboratory 

requirements, including any annual 

certification fee information, could be 

obtained by contacting the AMS 

Trichinae Program Manager. 

Proposed § 149.6(c)(3) would cover 

the requirements for process-verification 

testing relating to sample size and 

testing frequency. We would require 

that process-verification testing be 

performed in accordance with the 

following minimum standards relating 

to sample size and frequency: 

• Slaughter facility officials would 

need to determine the yearly processing 

capacity of the slaughter facility over 

the next 12 months. Officials could use 

the processing capacity during the past 

12 months if the past 12 months were 

representative of a typical year. 

• Slaughter facility officials would 

have to estimate the percentage of swine 

processed that would likely come from 

certified production sites considering all 

swine expected to be processed during 

the selected 12-month period. Swine 

that come from certified production 

sites would be considered the eligible 

population to be sampled. 

• Slaughter facility officials would 

then need to use the Trichinae 

Certification Slaughter Facility Sample 

Size Determination Table to determine 

the number of samples to collect from 

the population of swine from certified 

production sites. If the eligible 

population is not shown in the table, the 

next largest number would be used to 

determine the number of samples to 

collect. Slaughter facility officials would 

select from the table the number of 

samples to collect from the column that 

reflects a 99 percent confidence level of 

detecting a positive carcass in the 

population. The number selected would 

represent the total number of samples 

that slaughter facility officials would 

have to collect and test per year and per 

month during the selected 12-month 

period. 

• We would require that for each 

sample collected, slaughter facility 

officials would have to maintain the 

identity of the sample using the TIN of 

the certified production site that was the 

source of the swine from which the 

sample was taken. 

• FSIS program employees at the 

slaughter facility would review and 

verify that an adequate number of 

samples have been collected and proper 

frequency of collection is maintained. 

FSIS would report this information to 

APHIS. 

• AMS representatives would verify 

through a laboratory approval audit that 

the laboratory performing processverification testing is correctly following 

written procedures relating to the 

receipt, handling, identification, and 

testing of samples. These written 

procedures would have to be 

maintained by the laboratory in a 

quality assurance manual, as explained 

below under proposed § 149.6(c)(6). In 

addition, a laboratory that performs 

process-verification testing at a location 

other than the slaughter facility would 

have to include a declaration of 

methodology used to test samples when 

providing test results. 

• The APHIS Administrator may also, 

at APHIS’ expense, periodically request 

the testing of swine brought to the 

slaughter facility from specific certified 

production sites. Requests to test swine 

from specific certified production sites 

would count towards the slaughter 

facility’s total monthly testing 

requirement. 

Proposed § 149.6(c)(4) would cover 

the requirements with regard to the 

handling of test results. We would 

require that the results of processverification testing of certified swine 

handled at the slaughter facility be 

retained in a separate file or notebook as 

written records at the slaughter facility 

and be readily available for inspection 

by FSIS program employees. FSIS also 

would report to APHIS the results of all 

process-verification testing. 

In the event of a positive test result, 

the slaughter facility representative 

would have to immediately notify the 

FSIS program employee designated by 

the FSIS Administrator, who in turn 

would report the TIN of the certified 

production site that was the source of 

the swine from which the sample was 

taken and the test results of the affected 

sample to the respective APHIS area 

office. The following sequence of events 

would take place following a positive 

test result: 

• If a test sample is found positive 

based on the digestion method, then the 

certified production site that was the 

source of the swine from which the 

sample was taken would be decertified. 

• If a test sample is found positive 

based on an ELISA test method, and is 

confirmed positive by further testing 

using the digestion method, then the 

certified production site that was the 

source of the swine from which the 

sample was taken would be decertified. 

• If a test sample is found positive 

based on an ELISA test method, but is 

not confirmed positive by further testing 

using the digestion method, then the 

certified production site that was the 

source of the swine from which the 

sample was taken would be investigated 

by APHIS personnel. The investigation 

may include a spot audit of the affected 

site. Additional testing also may be 

performed. This investigation would 

determine if the production facility has 

sufficient safeguards and is following 

good production practices. While a 

certified production site is under 

investigation, the site’s program status 


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as a certified production site would be 

suspended. While a site is under 

suspension, the producer would have to 

continue to adhere to all good 

production practices and other 

recordkeeping and program 

requirements; however, swine from the 

suspended site could not be identified 

as product from a certified production 

site. The APHIS Administrator would 

determine the program status of the site 

within 30 days of the initiation of the 

suspension. A finding that risk factors 

are inadequately addressed in the site 

investigation or the finding of additional 

positive test results based on samples 

from animals or carcasses from the 

affected site would be grounds for 

APHIS decertification of the site. 

Proposed § 149.6(c)(5) would cover 

slaughter facility recordkeeping 

requirements relating to the handling of 

animals from certified production sites. 

We would require that all slaughter 

facilities that receive certified swine 

would have to maintain records with 

regard to the number of certified swine 

processed, the source of the certified 

swine, including the TIN of the certified 

production site from which the swine 

came, and all test results relating to 

process-verification testing. These 

records would have to be retained at the 

slaughter facility for a period of at least 

3 years following the processing of such 

animals. 

Slaughter facilities handling certified 

swine also would need to have 

documented procedures on how 

certified swine under its control, and 

the edible pork products derived from 

certified swine, would remain 

segregated from swine and edible pork 

products from noncertified sites 

throughout receiving, handling, and 

processing at the facility, as well as 

while awaiting shipment from the 

facility. The slaughter facility also 

would have to have documented 

procedures for maintaining the identity 

of the certified swine or pork with 

respect to the certified production site 

from which it came. 

We also would require that all records 

and other documentation required to be 

maintained by the slaughter facility 

under proposed part 149 would have to 

be readily available for inspection by 

FSIS program employees. 

Proposed § 149.6(c)(6) would cover 

recordkeeping requirements for 

approved laboratories that perform 

process-verification testing under this 

program. Approved laboratories would 

be required to have written procedures 

that specify standards for sample size, 

sample handling, sample identification, 

and sample test methods used in 

process-verification testing. All such 

written procedures would have to be 

maintained in a laboratory quality 

assurance manual specifically for this 

program, or as a separate section of an 

existing laboratory quality assurance 

manual, and would have to be retained 

at the approved laboratory throughout 

the time the approved laboratory is 

performing process-verification testing 

under this program. All such written 

procedures relating to processverification testing also would have to 

be readily available for inspection by 

FSIS program employees or AMS 

representatives. 

Proposed § 149.6(c)(7) would cover 

the slaughter facility overall 

responsibility for process-verification 

testing. In the event the testing is 

contracted to an outside approved 

laboratory, the slaughter facility would 

still retain overall responsibility that the 

testing is carried out as required. The 

slaughter facility would be responsible 

for obtaining testable samples and for 

ensuring that the correct number of 

testable samples are sent to the outside 

testing lab. Once the slaughtering 

facility receives those test results back 

from the outside testing lab, the 

slaughter facility would be responsible 

for maintaining those results in its 

trichinae testing records. 

Recordkeeping at Site 

Proposed § 149.7 would cover 

recordkeeping requirements for 

producers participating in the program. 

Under proposed § 149.7(a), Stage I 

enrolled sites, Stage II or Stage III 

certified sites, and any site that has been 

suspended or voluntarily decertified 

would have to maintain the following 

records: Animal disposal plan, animal 

movement record, feed mill quality 

assurance affidavit (if applicable), 

rodent control logbook, and waste 

feeding logbook (if applicable). All such 

records would have to be readily 

available for inspection at the pork 

production site at the time of an audit 

by a QAV or QVMO, or by other APHIS 

representatives during normal business 

hours. 

Animal Disposal Plan 

The animal disposal plan would have 

to meet certain minimum requirements. 

Specifically, the animal disposal plan 

would have to: 

• Provide for the removal of all dead 

swine or swine remains from swine 

pens immediately upon detection. 

Inspections for purposes of detecting 

dead animals would have to occur at 

least once every 24 hours. 

• Specify how often and at what 

intervals the swine pens are observed 

each day. 

• Provide for the proper storage of 

dead swine or swine remains in 

accordance with local, State, and 

Federal laws and regulations. If the 

carcass storage facility or composting 

facility is located on the site, then the 

animal disposal plan would have to 

provide for a storage or composting 

facility that precludes rodent or wildlife 

contact with dead swine or swine 

remains being stored or composted. 

• Provide for the disposal of swine 

and other mammals by rendering, 

incineration, composting, burial, or 

other means, as allowed by and in 

accordance with local, State, and 

Federal laws and regulations. For sites 

that use rendering services, the animal 

disposal plan also would have to 

include the name, address, and phone 

number of the renderer. 

• Be updated as animal disposal 

practices are changed at the site. 

• Be signed and dated by the 

producer as well as the caretaker of the 

site (if the caretaker is a different person 

than the producer). 

• Be valid for a period no longer than 

2 years after the date of signature by the 

producer and (if applicable) the site 

caretaker. 

Animal Movement Record 

The animal movement record would 

have to meet certain minimum 

requirements. Specifically, the animal 

movement record would have to: 

• Be filled out completely and 

properly, accounting for the movement 

of all non-breeding swine into and from 

the pork production site. 

• In the case of non-breeding swine 

coming into the site, include the date 

and number of arriving animals, as well 

as the TIN of the certified production 

site where the animals originated, or 

alternatively, if the swine are less than 

5 weeks of age and originated from a 

noncertified site, the name and full 

address of the noncertified site where 

the animals originated. The animal 

movement record would have to clearly 

document that all non-breeding swine 5 

weeks of age or older that arrive at the 

site originated from another certified 

production site. 

• In the case of non-breeding swine 

leaving the site, include the date and 

number of departing animals, and their 

destination. 

• Document the number of dead nonbreeding swine that are removed from 

the site, as well as the number of dead 

non-breeding swine that are buried or 

composted at the site, if swine burial or 

composting is permitted in that State or 

locality. 

All entries to the animal movement 

record would have to be signed or 


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initialed, as well as dated, by the 

producer or other site caretaker making 

the entry. We would take into account 

that pork production sites seeking Stage 

I enrolled status may have limited 

documentation regarding these 

activities. However, we would still 

require that such sites have initiated 

documentation that addresses these 

matters. The 180-day enrollment period 

would provide Stage I sites further 

opportunity to develop their 

recordkeeping. 

Rodent Control Logbook 

The rodent control logbook, which 

may include records from a pest control 

operator, would have to meet certain 

minimum requirements. Specifically, 

the rodent control logbook would have 

to: 

• Include a rodent control diagram for 

the site indicating the location of all 

rodent bait stations and rodent traps at 

the site. The diagram would have to be 

updated whenever bait stations are 

added, moved, or removed. 

• Document the number of rodent 

traps set (if applicable), the number of 

new rodent bait stations set, and how 

often bait is refreshed. 

• Document the disposal method for 

all unused bait that is replaced. 

• Document the brand name and 

active ingredient of bait, which would 

have to be EPA registered and applied 

according to its label, as well as the 

quantity of bait used (number of 

pounds). 

• If possible, document the number of 

rodents caught or killed and indicate 

whether they are mice or rats. 

• If possible, document the number of 

rats sighted monthly. 

All entries to the rodent control 

logbook would have to be signed or 

initialed, as well as dated, by the 

producer or other site caretaker making 

the entry. It would have to be updated 

at least monthly. 

Feed Mill Quality Assurance Affidavit 

The feed mill quality assurance 

affidavit, to be used in conjunction with 

feed or feed ingredients delivered to the 

pork production site, would have to 

meet certain minimum requirements. 

Specifically, the feed mill quality 

assurance affidavit would have to: 

• Include the name of the producer 

and the identity of the site, including 

the TIN if it has been issued, and the 

site address, as well as the name and 

address of the feed mill and the name 

and title of the feed mill representative. 

• Provide that the feed mill is 

following good manufacturing practices, 

and further specify, as evidence of these 

good manufacturing practices, the 

following: 

That the feed mill has a rodent control 

system that is maintained by the feed 

mill itself or by a pest control firm 

(include name and address of pest 

control firm); 

The frequency with which such 

rodent control system is maintained 

(i.e., on a weekly basis, etc.); and 

That the feed mill maintains records 

of pest management practices or has 

records generated by a pest control 

operator, which would have to be made 

available to the producer upon request. 

• Be signed by the feed mill 

representative and by the producer or 

the producer’s designated 

representative, and would remain in 

effect for a period of 2 years. 

Waste Feeding Logbook 

If the producer feeds meat-containing 

food waste to swine at the site, the 

producer would have to maintain a 

waste feeding logbook that meets certain 

minimum requirements. Specifically, 

the waste feeding logbook would have 

to: 

• Include the name of the producer 

and the identity of the site, including 

the TIN if it has been issued, the site 

address, and the number of the license 

or permit authorizing the feeding of 

such waste to swine. 

• Be kept up-to-date with 

documentation evidencing adherence to 

applicable State and Federal food waste 

feeding laws and regulations. 

• Provide information as to the 

method used in cooking the meatcontaining food waste. 

• For each batch of meat-containing 

food waste cooked, record the batch 

number (if applicable to the operation), 

the temperature at which such food 

waste is cooked and the length of time 

it is held at that temperature, and the 

method for verifying the temperature 

and length of time cooked. 

• For each batch of meat-containing 

food waste cooked, document the 

sources of meat. 

• Evaluate and document on at least 

a monthly basis the level of sanitation 

of the site, taking into account the 

following factors: 

Whether garbage containers are clean 

and covered with lids; 

Sanitation of cooking area and 

equipment; 

Sanitation of feeding areas and waste 

disposal; 

Sanitation of storage areas; 

Rodent control system around 

equipment, storage, and feeding areas; 

Sanitation of waste hauling trucks or 

containers; 

Access of other animal species to food 

waste (wild animals, dogs, cats, etc.); 

and 

The potential for cross-contamination 

between cooked product and raw meatcontaining food waste. 

All entries to the waste feeding 

logbook would have to be signed or 

initialed, as well as dated, by the 

producer or other site caretaker making 

the entry. 

Under proposed § 149.7(b), we would 

require that all required records and 

other documentation to be maintained 

by producers in the program would 

have to be kept at the pork production 

site for a period of 2 years. In addition, 

under proposed § 149.7(c), we would 

require that these records be readily 

available for inspection at the pork 

production site at the time of an audit 

by a QAV or QVMO, or by other APHIS 

representatives during normal business 

hours. 

Program Fees and Charges 

Proposed § 149.8 would address the 

subject of program fees and charges. The 

producer would be responsible for the 

cost of each site audit performed at the 

pork production site. If a QAV performs 

the site audit, then the producer would 

have to pay the QAV directly at a 

mutually agreed-upon time and rate. If 

a QVMO performs the site audit, then 

the producer would pay the QVMO at 

the time the site audit is performed in 

accordance with the rate and other 

conditions set by the QVMO’s 

governmental employer. Further, if the 

QVMO who performs the site audit is 

employed by APHIS, then the producer 

would have to pay APHIS for this 

service at a prescribed hourly rate as set 

forth in proposed § 149.8. We are 

proposing that the rates for the services 

of an APHIS-employed QVMO would be 

$84 per hour and $21 per quarter hour, 

with a minimum charge of $25 per 

service. If an APHIS-employed QVMO 

performs the site audit outside his or 

her normal tour of duty, then the rates 

would increase to $100 per hour and 

$25 per quarter hour for Monday 

through Saturday and holidays and 

$112 per hour and $28 per quarter hour 

for Sundays. These proposed rates are 

comparable to current rates charged for 

other veterinary services conducted by 

APHIS employees, and are designed to 

recover the cost incurred by APHIS in 

providing these services. Payment to 

APHIS for the services of an APHISemployed QVMO would have to be in 

the form of a certified check or U.S. 

money order and would have to be 

remitted to the QVMO at the time the 

service is provided. 


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In addition to the cost of the site 

audit, proposed § 149.8 would provide 

that the producer also would have to 

pay APHIS a program fee at the time of 

each site audit in the amount of $51 to 

cover APHIS’ administrative costs in 

processing the audit and operating the 

program. This program fee, payable to 

APHIS by certified check or U.S. money 

order, would be due at the time of 

submitting the completed site audit 

form for APHIS evaluation. This 

program fee would not be subject to 

refund, regardless of the results of the 

site audit or other determination as to 

the producer’s program status. 

Finally, proposed § 149.8 provides 

that a producer would not be charged 

for the cost of having a spot audit 

performed at the pork production site. 

Pilot Program Sites 

In proposed § 149.9, pork production 

sites that are participating in an APHISapproved trichinae pilot program at the 

time the final rule for establishing the 

Trichinae Certification Program 

becomes effective would maintain their 

same program status as either a Stage I 

enrolled, Stage II certified, or Stage III 

certified site, as well as their same 

program anniversary date for purposes 

of completing future site audits and 

submitting completed audit forms and 

payment. We are proposing this 

provision to recognize those producers 

that volunteered to participate in our 

pilot program and invested their time 

and effort, as well as the expenditure of 

money to upgrade their sites, in order to 

be in compliance with good production 

practices and other pilot program 

requirements. 

Changes to 9 CFR Part 160 

Section 160.1 of the regulations in 9 

CFR part 160 contains definitions for 

terms appearing in parts 160 through 

162 on accreditation of veterinarians. 

We are proposing to add a new 

definition to § 160.1 for the term 

qualified accredited veterinarian or 

QAV, which we would define as an 

accredited veterinarian who has been 

granted an accreditation specialization 

by the APHIS Administrator pursuant to 

§ 161.5 of our regulations based on 

completion of an APHIS-approved 

orientation or training program. We 

would make this change in conjunction 

with another proposed change to part 

161, as discussed below. 

Changes to 9 CFR Part 161 

The regulations in 9 CFR part 161 

contain the requirements and standards 

for accredited veterinarians and 

suspension or revocation of such 

accreditation. We are proposing to add 

a new § 161.5 on specializations for 

accredited veterinarians. Under 

proposed § 161.5, an accreditation 

specialization recognized by the APHIS 

Administrator may be granted to an 

accredited veterinarian upon 

completion of an orientation or training 

program approved by APHIS. An 

accredited veterinarian who is granted 

such a specialization would be referred 

to as a qualified accredited veterinarian 

or QAV. For certain accredited 

specializations, the cost of orientation or 

training would be borne by the 

accredited veterinarian. 

QAVs would be authorized to perform 

those activities and functions 

specifically provided for elsewhere in 

chapter I of 9 CFR. Additional 

information on accreditation 

specializations, including training 

requirements and fees, could be 

obtained by contacting the National 

Veterinary Accreditation Program, VS, 

APHIS, 4700 River Road Unit 46, 

Riverdale MD 20737, (301) 734–6188. 

Under proposed § 161.5, the 

Administrator of APHIS would grant the 

status of qualified accredited 

veterinarian or QAV to those accredited 

veterinarians who complete an APHISapproved orientation or training 

program covering that particular 

specialization. Therefore, an accredited 

veterinarian who completes the APHISapproved training in good production 

practices in swine management could 

become a QAV, and then be authorized 

to perform site audits and other 

specified program services under the 

Trichinae Certification Program in part 

149. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This proposed rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be significant 

for the purposes of Executive Order 

12866 and, therefore, has been reviewed 

by the Office of Management and 

Budget. 

For this proposed rule, we have 

prepared an economic analysis. The 

economic analysis, which is set out 

below, provides a cost-benefit analysis 

as required by Executive Order 12866 

and an analysis of the potential 

economic effects of this proposed rule 

on small entities as required by the 

Regulatory Flexibility Act. 

We currently do not have all of the 

data necessary for a comprehensive 

analysis of the effects of this proposed 

rule on small entities. Therefore, in 

accordance with 5 U.S.C. 603, we have 

prepared an initial regulatory flexibility 

analysis. We are inviting comments 

about potential effects of this proposed 

rule on small entities. In particular, we 

are interested in determining the 

number and kinds of small entities that 

may incur benefits or costs from the 

implementation of this proposed rule, 

and the economic effects of those 

benefits or costs. 

In accordance with the Animal Health 

Protection Act (7 U.S.C. 8301–8317), the 

Secretary of Agriculture has the 

authority to promulgate regulations and 

conduct programs to detect, control, or 

eradicate any pest or disease of livestock 

(including the drawing of blood and 

diagnostic testing of animals). Such 

programs can include animals at a 

slaughterhouse, stockyard, or other 

point of concentration. The Secretary 

may also cooperate with State 

authorities, Indian tribe authorities, or 

other persons in the administration of 

regulations for the improvement of 

livestock and livestock products. 

In accordance with 21 U.S.C. 601 et 

seq., the Secretary of Agriculture is 

authorized to inspect meat and meat 

products at any slaughtering, packing, 

meat-canning, rendering, or similar 

establishment, while under 21 U.S.C. 

451 et seq., the Secretary of Agriculture 

is authorized to inspect poultry and 

poultry products at official 

establishments. Finally, in accordance 

with 7 U.S.C. 1621 through 1627, the 

Secretary of Agriculture is authorized to 

provide a range of voluntary inspection, 

certification, and identification services 

to assist in the orderly marketing of 

various animal products and 

byproducts. 

Based upon available data and 

expected effects, we believe that some 

producers and facilities may come to the 

conclusion that the benefits of the 

proposed program, in terms of increased 

exports and lower costs to meet the 

requirements of importing countries, 

would justify the costs of their 

participation. 

Costs for Participating Producers 

According to USDA’s National 

Agricultural Statistics Service (NASS), 

there were an estimated 75,350 hog and 

pig producers in the United States in 

2002 [see NASS Agricultural Statistics, 

2003 (Table 7–26)]. This was down from 

80,880 producers in 2001. Since 2002, 

the number of producers has declined 

even further with 67,330 operations 

reported in 2005. Although the structure 

of the industry has changed over time, 

the number of hogs as well as 

consumption of pork has remained 

relatively constant over the same period. 

The number of producers who would 

participate in the certification program 

is not known. Participation by 

producers would depend primarily on 


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economic and other market 

competitiveness considerations. 

Participation will be based on how 

much of the producers’ pork would 

enter into export markets that have 

trichinae requirements. 

We believe that most producers, 

especially the larger ones, are likely to 

participate in the program. This is 

because they have already implemented 

and routinely follow many of the 

proposed good production practices 

required for certification. Industry 

experts have estimated that 90 to 95 

percent of commercial pork production 

sites in the United States could meet the 

proposed program requirements for site 

certification with, at most, only minimal 

facility changes (i.e., those costing 

approximately $500 over a 5-year 

period, equivalent to a present value of 

about $440 when discounted at 7 

percent). However, recent experience 

with the pilot program has shown that 

while 90 to 95 percent of these sites 

could meet the requirements with only 

minimal changes, it is likely that only 

40 to 50 percent would actually choose 

to participate. In general, larger 

producers have more mitigations in 

place so they are more readily able to 

participate. Small producers could 

participate in the program as well as 

long as they are able to meet program 

risk mitigations. At worst, only 

moderate facility changes (i.e., those 

that cost $2,500 over 5 years) would 

likely be required. The estimated cost of 

$2,500 for moderate facility changes 

consists of $1,500 in first year startup 

costs and maintenance costs of $250 per 

year for the next 4 years. (For further 

information, see Cummings, David and 

Kopral, Christine, ‘‘Cost Analysis of 

Trichinae-Free Program Alternatives,’’

USDA, APHIS, Centers for 

Epidemiology and Animal Health, 

December 1998, referred to below as the 

CEAH analysis. Copies of the CEAH 

analysis are available by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT). 

Producers seeking to participate in the 

program would be required to pay the 

veterinarians’ audit fees to perform both 

the initial and subsequent site audits. 

These fees are estimated at about $150 

per audit. After the first three audits are 

completed over a 15-month period at a 

cost of $450, certified production sites 

would be subject to audits only once 

every 15 months. 

In addition to the cost of the site 

audit, the producer would be 

responsible for paying a separate 

program fee to APHIS at the time of 

each site audit. This program fee would 

cover APHIS’ administrative costs in 

processing the audit and operating the 

program. As proposed, the program fee 

would be $51. Also, producers may 

have to pay for the postmortem blood, 

tissue, or meat juice sample tests if the 

cost of these tests is passed on to them 

by the slaughter facilities. 

Based on the information presented in 

the preceding paragraphs, we have 

prepared the following table 

summarizing the estimated costs of 

participating in the program over 5 

years: 

TABLE 2.—ESTIMATED COSTS FOR PARTICIPATING PRODUCERS

Year 

1 2 3 4 5 

Estimated site audit fees ................................................................................................................. $300 $150 $150 $150 $150 

Program fees ................................................................................................................................... 102 51 51 51 51 

Subtotal ..................................................................................................................................... 1 402 2 201 3 201 3 201 3 201 

Facility improvement costs: 4

Minimal ...................................................................................................................................... 100 100 100 100 100 

Moderate ................................................................................................................................... 1,500 250 250 250 250 

Yearly total ......................................................................................................................... $502 to $1,902 year 1; $301 to $451 each 

year, years 2 to 5. 

5-year total ......................................................................................................................... $1,706 to $3,706 over 5 years. 

1Assumes site audit and program fees for attaining both Stage I Enrolled and Stage II Certified status during year 1. 

2Site audit and program fees for moving from Stage II to Stage III Certified status. 

3Site audit and program fees for renewal of Stage III Certified status. 

4Experience with the pilot program has shown that 90 to 95 percent of sites could meet program requirements with only minimal facility improvements, so only 5 to 10 percent of sites might have to incur the moderate facility improvement costs. 

For producers that decide to 

participate in the program, a potential 

downside is the possibility that swine 

from their sites could test positive for 

trichinae at slaughter, resulting in a loss 

of program status as a certified site. 

Once a site is decertified, swine from 

that site could not be identified as 

product from a certified production site. 

In order to participate in the program 

once again, the producer would have to 

follow the procedures for requesting an 

initial audit for Stage I enrolled status. 

It is reasonable to assume that most 

producers who decide not to participate 

in this program would be small in size, 

although there are some small producers 

that would also need to make only 

minimal changes to satisfy program 

requirements. 

Costs for Participating Slaughter 

Facilities 

The number of slaughter facilities that 

may wish to process certified swine and 

export their meat as produced under the 

Trichinae Certification Program is 

uncertain. As with producers, 

participation would depend on 

economic competitiveness 

considerations. Certain countries that 

import pork require testing for trichinae. 

Therefore, any facility that wants to 

export pork must meet these testing 

requirements. Slaughter facilities would 

have to determine whether it would be 

better to continue to follow their 

traditional trichinae testing protocols, or 

whether sourcing animals from certified 

producers while observing the program 

requirements for slaughter facilities 

would provide them an economic 

incentive. 

Slaughter facilities that purchase 

swine from certified production sites 

would be required to carry out certain 

functions relating to verification, 

segregation, testing, and recordkeeping 

of certified swine under its control. 

Testing at the slaughter facility would 

entail taking tissue, blood, or meat juice 

specimens from a sample of the certified 

swine population processed at the 

facility in order to determine the 


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3These figures are from the CEAH analysis. It is 

important that because the CEAH study was 

published in 1998, the findings are somewhat dated 

Throughout this analysis, the data used in the 

CEAH analysis have been updated where possible 

in order to obtain a more current estimate of the 

cost. 

Trichinella spiralis infection status of 

the tested animals and to verify that the 

trichinae management practices at the 

production level are adequate. The 

number of required test samples would 

vary among individual facilities, 

depending on the total number of 

animals from certified production sites 

that are slaughtered. The testing 

requirements are designed to produce a 

99 percent confidence level of detecting 

a positive carcass in the population 

based on a prevalence of 0.013 percent. 

For example, a plant that slaughters 1 

million certified swine per year would 

be required to run 34,802 tests annually, 

but a plant that slaughters 5,000 

certified swine per year would need to 

run 4,996 tests each year. 

Slaughter facilities could conduct 

sample testing using either an ELISA or 

a pooled diaphragm test and would 

have the option of processing the test 

samples themselves at the slaughter 

facility or sending it to an offsite 

commercial laboratory. On-site 

processing of test samples should result 

in lower costs per test once the 

necessary testing equipment is in place. 

In this regard, it is anticipated that 

many slaughter facilities, especially the 

large and medium ones, would acquire 

ELISA test readers, regardless of 

whether they participate in the 

certification program, due to FSIS’

HACCP inspection procedures and 

because of the public’s demand for food 

safety and quality. ELISA test readers 

cost about $5,000 each, while pooled 

diaphragm digestion test readers cost 

$2,900. 

An ELISA test costs approximately 

$0.83 per swine using the services of a 

commercial laboratory, and up to $0.66 

per swine if processed by the slaughter 

facility itself. By comparison, a 

digestion test costs approximately $1.72 

per swine if processed by a commercial 

laboratory, and $0.92 per swine if 

processed by the slaughter facility.3

An ELISA test, therefore, is less costly 

than a digestion test. However, if an 

ELISA test is used and the results are 

positive, then those findings would 

have to be confirmed by using a 

digestion test. For a large slaughter 

facility required to run 34,802 tests each 

year, the ELISA test would cost $28,886 

annually if processed by a commercial 

laboratory and $22,969 if processed by 

the slaughter facility itself, and the 

digestion test would cost $59,859 

annually if processed by a commercial 

laboratory and $32,018 if processed by 

the slaughter facility itself. For a small 

plant required to run 4,996 tests each 

year, the ELISA test would cost $4,147 

annually off site and $3,297 annually on 

site, and the digestion test would cost 

$8,593 annually off site and $4,596 

annually on site. 

As discussed above, the number of 

slaughter facilities that would 

participate in the program by 

purchasing swine from certified 

production sites is uncertain. If 

slaughter facilities do wish to accept 

certified swine and identify pork as 

produced under the Trichinae 

Certification Program, it is not known 

whether they would absorb all the 

testing costs or pass on some of those 

costs to producers or consumers. 

Slaughter facilities may experience 

negative effects from this proposed rule 

in the event of a trichinae positive test. 

Given the rarity of trichinae in swine 

currently, the likelihood of a positive 

test from an animal that comes from a 

certified production site would be 

small. However, if there was a positive 

test result, presumably there would be 

some cost to the slaughter facility since 

it could lose a source of certified 

animals if the site is decertified. The 

total cost to the slaughter facility in the 

event of a positive test is uncertain at 

this time. 

Costs for Participating Accredited 

Veterinarians 

The proposed rule would provide 

accredited veterinarians who are 

qualified to conduct site audits under 

the program with another source of 

revenue. To become qualified, 

accredited veterinarians would need to 

complete an APHIS-approved 

orientation or training program in good 

production practices in swine 

management. At least initially, APHIS 

would provide this special training to 

accredited veterinarians itself, charging 

them an amount sufficient to recover the 

Agency’s costs, estimated at $50 per 

trainee. QAVs would need 

requalification training, but this would 

not occur more than once every 2 years, 

and the accredited veterinarians would 

be charged the same $50 fee. Currently, 

veterinarians do not have to pay a fee 

or receive periodic training to maintain 

accreditation status. However, for 

certain accredited specializations, such 

as conducting site audits under the 

trichinae certification program, we are 

proposing that the accredited 

veterinarian would be responsible for 

the cost of orientation and periodic 

training to perform this activity. 

The special training would not be 

mandatory for accredited veterinarians, 

so any training costs would be 

voluntarily assumed. For those 

accredited veterinarians who do opt for 

the training in order to perform site 

audits for producers, the cost of the 

training would be offset by income in 

the form of fees received from producers 

for site audits. 

Impact on Federal Agencies 

Unlike traditional disease eradication 

programs, herd certification programs 

are indefinite, and exist for as long as 

the producer wishes to maintain 

certification status. Due to the changes 

in the meat inspection process that have 

occurred at the slaughter and processing 

level, increasingly, packers will require 

various forms of food security 

certifications as criteria for producers 

that wish to sell their product to them. 

In fiscal year (FY) 2007, trichinae 

certification activities would shift from 

being in the pilot phase to the early 

national program roll out phase, 

assuming this proposed rule is 

implemented. In late FY 2007 or early 

FY 2008, the trichinae certification 

program would become a national 

program, available in increasing 

numbers of States and involving 

potentially thousands of herds. Initial 

national program emphasis would be 

placed on 5 of the 17 major swine 

producing States that account for 

approximately 94 percent of the 

Nation’s total swine production, but the 

program would be made available to all 

who volunteer to participate. 

Successful implementation of the 

trichinae certification program would 

require integration of APHIS on-farm 

activities with AMS and FSIS plant and 

processing actions to ensure the safety 

and quality of animal derived food 

products. The impacts on AMS and 

FSIS are expected to be minimal. AMS 

representatives would certify 

laboratories with respect to trichinae 

testing, and FSIS program employees 

would check records in plants to ensure 

compliance with testing and 

recordkeeping requirements, as well as 

provide general oversight that plants are 

carrying out other program 

responsibilities properly. The personnel 

and time requirements for AMS and 

FSIS to meet their obligations are not 

expected to be significant. 

Export Benefits Associated with the 

Program 

The proposed program is designed to 

increase sales and marketability of fresh 

pork products destined for foreign 

markets, which would benefit 


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4Testing costs are derived from the 1998 CEAH 

study and have been adjusted for inflation. Freezing 

costs were obtained from Dave Pyburn, the APHIS 

National Trichinae Coordinator. 

participating swine producers and 

slaughter facilities. 

The United States is a net exporter of 

pork and has been the second largest 

exporter of pork, trailing the European 

Union (EU), in recent years. Other major 

exporters include Canada and Brazil. 

Japan, Mexico, and Canada are the 

primary markets for U.S. pork exports. 

The United States also exports pork to 

Russia and the EU, but these averaged 

less than 5 percent of total exports over 

the 2000 to 2005 period. Additionally, 

the United States is a net importer of 

pork in trade with the EU, with exports 

to the EU declining from 2001 to 2005. 

Although not certain, a voluntary 

trichinae certification program could 

increase opportunities for participating 

producers and slaughter facilities to 

export to countries that monitor for 

Trichinella spiralis in pork. 

How much this program would 

increase U.S. pork exports is not known. 

U.S. pork exports have been increasing 

for the past decade and are expected to 

continue to increase. Approximately 9 

percent of U.S. pork production is 

exported. Given the steady per capita 

domestic consumption over the past 

decade, if U.S. pork production is to 

continue to grow, the growth likely will 

be driven by export demand. A 

voluntary trichinae certification 

program is one step in keeping U.S. 

producers competitive in the world 

market. 

According to Canadian animal health 

personnel, maintaining trichinae free 

status for most of Canada has been 

instrumental in facilitating the country’s 

$1 billion annual export market for pork 

($410 million in fresh cuts), as well as 

in maintaining its annual per capita 

consumption of pork totaling 28 kg (H. 

Ray Gamble, Trichinae Fact Sheet, 

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

trichinae/). However, it should be noted 

that the majority of Canadian exports of 

pork go to the United States and 

Mexico, neither of which have 

trichinae-specific entry requirements for 

imported pork. So while it may be 

helpful, it is not certain that the 

proposed voluntary trichinae 

certification program would 

automatically lead directly to increased 

exports of pork and pork products. 

The EU and Russia have traditionally 

been markets where the United States 

has not had a large presence. It is the 

industry’s hope that the certification 

program would open these markets to 

more pork from the United States. The 

United States recently signed an 

agreement with the Russian Federation 

that would allow pork into Russia either 

after being tested for trichinae or frozen. 

Before now, Russia required both in 

order to be permitted into the country. 

Additionally, Brazil has historically 

been Russia’s largest supplier of pork. 

However, outbreaks of foot-and-mouth 

disease in the latter part of 2005 

hampered Brazil’s ability to supply that 

market. Thus, other exporters, including 

the United States, are looking to 

capitalize on this opportunity to gain 

market share in the Russian pork 

market. 

The voluntary certification program 

could potentially lead to increased 

exports to countries that require 

trichinae testing, such as the European 

Union. The U.S. Meat Export Federation 

(USMEF) believes U.S. exports to the EU 

would increase with the certification of 

new EU-approved plants and reduction 

in costs associated with trichinae 

testing. The weak dollar will also help 

the cause of U.S. exports. Increases in 

exports may not be immediate since 

there are currently only three EUapproved plants that are not able to fill 

the U.S. quota. Furthermore, the USMEF 

sees a potential for growth in the 

processed pork products market, i.e., 

fully cooked bacon, rather than the 

fresh, chilled, and frozen sector. 

Currently, domestic exporters face a 

duty free quota of 45,000 metric tons of 

pork to the EU. In 2005, the United 

States sent approximately 6,600 metric 

tons of pork to the EU, which accounted 

for 0.7 percent of total U.S. exports. If 

exports to the EU were to increase by 

16,000 metric tons over those reported 

in 2005 as expected by the National 

Pork Producers Council (NPPC), the EU 

share of U.S. exports would increase to 

approximately 2.5 percent. 

Additionally, the NPPC estimates that 

an increase of this magnitude would 

increase the value of exports by $60 

million. This represents a threefold 

increase in the 2005 value of exports to 

the EU, or a 3.4 percent share of the 

total $2.3 billion pork export market. 

However, based on historical unit 

values for U.S. exports of pork to the EU 

and the world and the estimated 

increase in exports to the EU, the value 

increase predicted by the NPPC appears 

to be overly optimistic. Additionally, 

based on the expert opinion of pork 

analysts at USDA’s Economic Research 

Service, it is unlikely that the voluntary 

certification program would change the 

European Union’s mix of pork imports. 

Testing costs under the voluntary 

certification program outweigh the costs 

of testing and freezing under the current 

regime. This is a result of the fact that 

the United States does not export large 

amounts of pork to countries having 

mandatory testing and freezing 

requirements. In fact, the average costs 

of testing and freezing per pig 

slaughtered are $0.02,4 compared to 

$0.15 in the lowest cost scenario under 

the voluntary certification program. 

This cost comparison assumes the same 

slaughter numbers in both cases, and a 

50 percent participation rate in the 

trichinae certification program. 

However, there may be certain 

producers that would benefit since 

APHIS is not able to look at each 

producer individually and must average 

results across all producers. APHIS 

welcomes any comments the public may 

have on the potential cost savings 

related to testing and freezing. 

Cost-Benefit Summary 

As discussed, producers, slaughter 

facilities, and accredited veterinarians 

would be subject to certain costs if they 

chose to participate in the trichinae 

certification program. Producers would 

likely incur added expenses to ensure 

that their sites meet good production 

practices. Similarly, slaughter facilities 

that choose to receive certified swine for 

processing also would likely incur 

additional costs in following program 

requirements, including the testing of 

certified swine processed at the facility 

in order to verify that the good 

production practices at the production 

level are adequate. Accredited 

veterinarians who wish to perform site 

audits would have to pay the cost of the 

training that would be necessary before 

performing this service for producers. 

The program itself would not impose 

additional costs on U.S. consumers, 

although some slaughter facilities may 

pass on a portion of their costs to 

consumers. 

As indicated in the CEAH analysis, a 

voluntary certification program 

involving periodic testing at slaughter 

would be less expensive than a program 

that would involve mandatory national 

testing. Also, because the program is 

voluntary, producers who judge the 

costs to exceed the benefits for their 

individual operation could opt not to 

participate in the program. 

We expect that costs incurred by 

producers, slaughter facilities, and 

accredited veterinarians in choosing to 

participate in the voluntary program 

would be justified in the long term by 

the program’s export and food safety 

benefits. Producers and slaughter 

facilities should benefit from increased 

export opportunities that develop as a 

result of the increased availability of 

certified pork products, while 

accredited veterinarians participating in 


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the program would have a potential 

source of additional income. 

Alternatives to the Proposed Rule 

In considering alternatives to the 

proposed rule, we looked to the findings 

of the CEAH analysis of Trichinae 

Certification Program alternatives. The 

CEAH analysis compared the costs of 

two alternative methods for achieving 

Trichinae Certification Program status 

in U.S. swine: An evolving on-farm 

certification program (i.e., voluntary 

program) that involves periodic testing 

at the slaughter facility versus a national 

carcass testing program by the pooled 

sample digestion method (i.e., 

mandatory program). Part I of the CEAH 

analysis describes inputs, assumptions, 

and projected costs for an evolving onfarm certification alternative. Part II 

describes inputs, assumptions, and 

projected costs for a national carcass 

testing program using the digestion 

method. 

Bottom-line results of this analysis are 

expressed as average annual cost per pig 

over 5 years. It is important to note that 

where possible, the data in the CEAH 

study have been updated through 2002 

in order to obtain better estimates of the 

cost of a voluntary certification program 

versus a mandatory program. Where 

recent data were not available, data from 

the 1998 study was used and adjusted 

for inflation in years 2 through 5. 

Although startup and maintenance costs 

for on-farm certification were averaged 

over 5 years, actual spending by 

producers may be higher in the first year 

and lower in years 2 through 5 of each 

5-year period. 

In the CEAH analysis, one component 

of proposed on-farm certification is 

periodic ELISA testing at slaughter. 

Projected costs for on-farm certification 

were calculated in Part I under options 

in which (1) large and medium 

slaughter facilities do required ELISA 

testing monthly and (2) large and 

medium slaughter facilities do ELISA 

testing quarterly. It was assumed that 

small slaughter facilities could only 

accomplish the required ELISA testing 

quarterly. 

Voluntary Certification Program 

In projecting costs for on-farm 

certification using ELISA testing, the 

most influential variables were the 

percentage of U.S. producers that would 

incur zero, minimal, or moderate costs 

to establish and maintain good 

production practices (GPP) sufficient for 

on-farm certification, and how much 

these costs would be. Regarding the 

percentages of sites that would incur 

costs, it was necessary to consider a 

range of scenarios because data, 

experiences, and perceptions varied 

significantly. The three GPP scenarios 

appear in table 3 below. Regarding the 

dollar amounts of those costs, minimal 

startup and maintenance costs were 

estimated to be $500 over 5 years, and 

moderate costs to be $2,500 over 5 

years. 

TABLE 3.—AVERAGE ANNUAL COST PER PIG UNDER ON-FARM CERTIFICATION

Percentage of sites that would incur no additional costs, minimal GPP costs, or moderate GPP costs 

Average annual 

cost per pig over 

5 years 

(a) Based on monthly ELISA testing at large/medium facilities: 

Scenario 1: 90, 5, 5 ................................................................................................................................................................ $0.148 

Scenario 2: 36, 32, 32 ............................................................................................................................................................ 0.225 

Scenario 3: 4, 48, 48 .............................................................................................................................................................. 0.271 

(b) Based on quarterly ELISA testing at large/medium facilities: 

Scenario 1: 90, 5, 5 ................................................................................................................................................................ 0.142 

Scenario 2: 36, 32, 32 ............................................................................................................................................................ 0.219 

Scenario 3: 4, 48, 48 .............................................................................................................................................................. 0.265 

Mandatory Certification Program 

The alternative program, national 

carcass testing by the digestion method 

as described in Part II of the CEAH 

analysis, would entail testing every 

carcass at slaughter. Under this option, 

USDA would require swine producers 

to participate in a trichinae certification 

program. The CEAH analysis assumes 

that 95 percent of all sites would be 

certified under a mandatory program. 

Sites that are not certified would have 

to have their swine undergo testing by 

the digestion method at slaughter. The 

producers of these non-certified animals 

would assume the cost of testing. 

It is assumed that larger facilities 

would use their own laboratories for 

testing, and smaller facilities would 

send their samples to independent 

laboratories for testing. All laboratories 

would be monitored by AMS. Average 

annual cost per pig under national 

carcass testing by the digestion method 

was calculated to be $0.854, which 

significantly exceeded the highest cost 

scenario for an on-farm certification 

program. 

Would the additional benefits of a 

mandatory program outweigh the costs? 

The CEAH analysis shows that a 

voluntary certification program 

involving periodic testing at slaughter is 

less expensive than under a national 

carcass testing program using the 

digestion method. While there are no 

cost estimates for producers who choose 

not to participate in a voluntary 

program, it is reasonable to assume that 

they choose not to participate based on 

some benefit-cost calculation, either 

formal or informal (i.e., costs of 

participating outweigh the benefits). 

The CEAH analysis assumes that most 

of the sites that would not participate in 

a voluntary program would involve 

producers with fewer than 100 head of 

swine. These producers would qualify 

as small businesses under the Small 

Business Administration (SBA) criteria, 

under which producers with not more 

than $750,000 in annual receipts are 

considered small businesses. Imposing a 

mandatory certification program could 

place an undue burden on swine 

producers considered to be small 

businesses. 

Maintain Status Quo 

Under this option, USDA would not 

establish a voluntary trichinae 

certification program. Producers and 

consumers would forgo benefits 

associated with the program and any 

potential benefits from increased 

exports and improved food safety would 

not be realized. Producers exporting to 

countries that monitor for Trichinella 

spiralis in pork would have to continue 

to test individual animals. The savings 

that could be realized from a voluntary 

certification program that would require 

testing only a sample of animals would 

not be captured. 

Initial Regulatory Flexibility Analysis 

The Regulatory Flexibility Act 

requires agencies to evaluate the 

potential effects of their proposed and 


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final rules on small business, small 

organizations and small governmental 

jurisdictions. Section 603 of the Act 

requires agencies to prepare and make 

available for public comment an initial 

regulatory flexibility analysis (IRFA) 

that describes expected impacts of a 

proposed rule on small entities. Section 

603(b) of the Act specifies that an IRFA 

shall contain: 

• A description of the reasons why 

action by the agency is being 

considered; 

• A succinct statement of the 

objectives of, and legal basis for, the 

proposed rule; 

• A description of and, where 

feasible, an estimate of the number of 

small entities to which the proposed 

rule will apply; 

• A description of the projected 

reporting, recordkeeping and other 

compliance requirements of the 

proposed rule including an estimate of 

the classes of small entities which will 

be subject to the requirement and the 

type of professional skills necessary for 

preparation of the report or record; 

• An identification, to the extent 

practicable, of all relevant Federal rules 

which may duplicate, overlap or 

conflict with the proposed rule; 

• A description of any significant 

alternatives to the proposed rule which 

accomplish the stated objectives of 

applicable statutes and which minimize 

any significant economic impact of the 

proposed rule on small entities. 

Reasons for the Action 

APHIS is proposing a voluntary 

trichinae certification program. 

Currently, any pork going into the 

European Union and Russia, along with 

a few other countries, must be tested 

and found free of Trichinella spiralis. 

Additionally, the meat must be frozen 

before shipment. Under the proposed 

voluntary program, producers could 

choose to certify a production site rather 

than undergo testing of each carcass at 

the slaughter facility that is destined for 

certain markets. 

Due to favorable changes in Europe 

regarding the certification of slaughter 

facilities in the United States, industry 

participants feel a certification program 

like the one proposed here could help 

domestic producers obtain a larger share 

of the EU market, as well as open that 

market to the exportation of fresh 

chilled, rather than frozen, products. 

Additional market forces, combined 

with the effects of this voluntary 

program, may also open the Russian 

market to additional imports of U.S. 

pork. 

Objectives and Legal Basis 

The objective of the rule is to give 

producers the ability to certify a 

production site rather than testing each 

individual carcass destined for markets 

that require trichinae testing, 

specifically the EU and Russia. The 

certification program presented here 

would be strictly voluntary, thus APHIS 

would not require producers to undergo 

certification. The program is based on 

APHIS’ authority under the Animal 

Health Protection Act. 

Small Entities That May Be Affected 

The proposed rule, if implemented, 

would have potential implications for 

swine producers and slaughter facilities 

both in terms of the costs they might 

incur to satisfy program requirements 

and in terms of the benefits associated 

with any increase in fresh pork sales as 

a result of the program’s establishment. 

For both producers and slaughter 

facilities, the majority of establishments 

that we expect to take part in the 

program are small entities (not more 

than $750,000 in annual receipts for 

producers and 500 employees for 

slaughter facilities). Over 80 percent of 

U.S. swine producers and 95 percent of 

slaughter facilities are small businesses 

according to these SBA guidelines. 

Participation of producers in the 

trichinae certification program would be 

voluntary. Small operations could 

decide not to participate in the program 

if they believe the costs of maintaining 

certified status outweigh the benefits of 

producing certified swine. Slaughter 

facilities would also face this decision. 

Because participation is voluntary, the 

proposed rule is not expected to have an 

adverse impact on small businesses. 

Reporting, Recordkeeping, and Other 

Compliance Requirements 

Producers would have to pay for a site 

audit by the accredited veterinarian, 

program fees for certification from 

APHIS, and possibly testing. Slaughter 

facilities that purchase swine from 

certified production sites would be 

required to carry out certain functions 

relating to verification, segregation, 

testing, and recordkeeping of certified 

swine under its control. Thus, the 

slaughter facility would have to keep 

records of the number of animals 

slaughtered from certified sites. They 

would also have to make sure that 

certified and non-certified animals were 

kept separate throughout the whole 

process. These facilities would also be 

responsible for keeping records related 

to testing. In the end, however, it is a 

voluntary program, so participants only 

take on this burden if they feel the 

program would benefit them. 

Duplicating, Overlapping, or Conflicting 

Federal Rules 

APHIS has not identified any 

duplication, overlap, or conflict of the 

proposed rule with other Federal rules. 

Economic Impact on Small Entities 

The Agency does not expect the 

proposed rule to result in significant 

economic impacts on small entities, and 

has therefore not set forth alternatives to 

minimize such impacts. Participation of 

producers in the Trichinae Certification 

Program would be voluntary. Small 

operations could opt to not join or 

withdraw from the program if they 

found the costs of maintaining certified 

status outweigh the benefits of 

producing certified swine. Because it is 

voluntary, the proposed rule is not 

expected to have an adverse impact on 

small businesses. 

Summary of Initial Regulatory 

Flexibility Analysis 

The proposed rule would establish a 

voluntary trichinae certification 

program. Producers who wish to 

participate would have to pay for an 

audit by an accredited veterinarian of 

their site. Additionally, they may incur 

the costs of carcass testing if the 

slaughter facility conducting the testing 

passes that cost to the producer. 

However, since this is a purely 

voluntary program, producers may opt 

not to incur any of these expenses. 

Individuals in the pork industry are 

hopeful this certification program 

would help domestic producers gain 

market share in countries that require 

trichinae testing, particularly the EU 

and Russia. The EU is reducing the 

certification requirements for slaughter 

facilities, and industry participants feel 

the voluntary certification program 

would substitute for the mandatory 

testing of all carcasses destined for that 

market. The benefits of the rule lie in its 

potential to open markets requiring 

mandatory trichinae testing to 

additional domestic product. However, 

the extent to which these markets would 

open is unknown. Costs under the 

certification program appear to be 

higher than current testing costs due to 

the fact that a small amount of product 

is currently sent to the EU and Russia. 

However, certain producers may find it 

to their advantage to participate given 

their particular situation. Since the 

program is voluntary and does not 

impose any costs on producers not 

wishing to participate, small entities 

would not be negatively impacted by 

this proposed rule. In the end, 


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producers will participate in the 

program if they feel the benefits 

garnered from the certification program 

will outweigh the costs they incur. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. If this proposed rule is 

adopted: (1) All State and local laws and 

regulations that are in conflict with this 

rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 

National Environmental Policy Act 

An environmental assessment has 

been prepared for this proposed rule. 

The assessment provides a basis for the 

conclusion that the implementation of 

the Trichinae Certification Program, as 

provided for in the proposed rule, 

would preclude any potential adverse 

effects on endangered and threatened 

species and their habitats, and would 

not have a significant impact on the 

quality of the human environment. 

The environmental assessment has 

been prepared in accordance with: (1) 

The National Environmental Policy Act 

of 1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The environmental assessment may 

be viewed on the Regulations.gov Web 

site or in our reading room. (Instructions 

for accessing Regulations.gov and 

information on the location and hours of 

the reading room are provided under the 

heading ADDRESSES at the beginning of 

this proposed rule.) In addition, copies 

may be obtained by calling or writing to 

the individual listed under FOR FURTHER

INFORMATION CONTACT. Comments on the 

environmental assessment may be 

submitted using the methods described 

under ADDRESSES. 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

requirements included in this proposed 

rule have been submitted for approval to 

the Office of Management and Budget 

(OMB). Please send written comments 

to the Office of Information and 

Regulatory Affairs, OMB, Attention: 

Desk Officer for APHIS, Washington, DC 

20503. Please state that your comments 

refer to Docket No. APHIS–2006–0089. 

Please send a copy of your comments to: 

(1) Docket No. APHIS–2006–0089, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road, Unit 118, Riverdale, MD 

20737–1238, and (2) Clearance Officer, 

OCIO, USDA, room 404–W, 14th Street 

and Independence Avenue, SW., 

Washington, DC 20250. A comment to 

OMB is best assured of having its full 

effect if OMB receives it within 30 days 

of publication of this proposed rule. 

The proposed Trichinae Certification 

Program is a voluntary program to 

certify pork as produced under good 

production practices that reduce, 

eliminate, or avoid the animal’s risk of 

exposure to Trichinella spiralis 

infection risk factors. Trichinella 

spiralis or trichinae is a parasitic disease 

of warm-blooded carnivores and 

omnivores, including swine. Uniform 

program standards have been developed 

by organizations representing the pork 

industry, State animal health agencies, 

and USDA. These standards provide the 

guidelines for implementing the 

requirements for this voluntary 

program. 

In this program, pork production sites 

would be audited by USDA trained and 

accredited veterinarians. During the site 

audit, the veterinarian would observe 

and collect information about the site, 

including swine sources, feed sources, 

rodent and wildlife control, and facility 

hygiene. This information would be 

collected on USDA-approved official 

program audit forms. APHIS would 

review the information obtained from 

the site audit to ensure that the required 

program standards relating to good 

production practices are in place and 

being maintained at the site in order to 

reduce, eliminate, or avoid the risk of 

exposure of swine to trichinae. APHIS 

would maintain a database containing 

records for each pork production site 

participating in the program. Listings of 

certified production sites by TIN and 

program status would be posted on the 

Trichinae Certification Program Web 

site at http://www.aphis.usda.gov/vs/ 

trichinae and would be accessible to 

APHIS personnel, as well as slaughter 

facility representatives whose facilities 

handle certified swine. 

In most instances, the information 

relating to a pork production site’s 

adherence to required good production 

practices would be collected during the 

audit. Completed forms would be 

submitted to the local APHIS area office. 

Site suitability for program enrollment 

or certification would be determined by 

the local APHIS area office. Program 

data would be entered locally. National 

summary data would be available to 

APHIS personnel involved in 

administering the program. 

Producers choosing to participate in 

the program would be subject to certain 

recordkeeping requirements that 

evidence their adherence to all of the 

required good production practices. 

Producers would have to maintain the 

following records: Animal disposal 

plan, animal movement record, feed 

mill quality assurance affidavit (if 

applicable), rodent control logbook, and 

waste feeding logbook (if applicable). 

Slaughter facilities handling certified 

swine also would be subject to certain 

recordkeeping requirements as to the 

number of certified swine processed, the 

source of the certified swine, and test 

results relating to process-verification 

testing. Such slaughter facilities also 

would be required to have documented 

procedures on how certified swine 

under its control, and the edible pork 

products derived from these animals, 

would remain segregated from swine 

and pork from noncertified sources. 

Approved laboratories that perform 

process-verification testing under the 

Trichinae Certification Program would 

be required to maintain written 

procedures that pertain to the 

performance of process-verification 

testing. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our proposed information 

collection and recordkeeping 

requirements. These comments will 

help us: 

(1) Evaluate whether the proposed 

information collection is necessary for 

the proper performance of our agency’s 

functions, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the proposed 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 


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1The labeling of all certified pork or pork 

products leaving a slaughter or processing facility 

must comply with 9 CFR 317.4 and all other 

applicable FSIS labeling regulations. 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 0.3842102 hours 

per response. 

Respondents: Auditors, herd owners, 

slaughter facilities, and approved 

laboratories. 

Estimated annual number of 

respondents: 54,500. 

Estimated annual number of 

responses per respondent: 2.992532. 

Estimated annual number of 

responses: 163,093. 

Estimated total annual burden on 

respondents: 62,662 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

Copies of this information collection 

can be obtained from Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 734–7477. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this proposed rule, please contact 

Mrs. Celeste Sickles, APHIS’

Information Collection Coordinator, at 

(301) 734–7477. 

List of Subjects 

9 CFR Part 149 

Animal diseases, Hogs, Laboratories, 

Meat and meat products, Meat 

inspection, Reporting and 

recordkeeping requirements. 

9 CFR Part 160 

Veterinarians. 

9 CFR Part 161 

Reporting and recordkeeping 

requirements, Veterinarians. 

Accordingly, we propose to amend 

title 9 CFR chapter I as follows: 

SUBCHAPTER G—LIVESTOCK 

IMPROVEMENT 

1. In subchapter G, the subchapter 

heading would be revised to read as set 

forth above. 

2. In subchapter G, a new part 149 

would be added to read as follows: 

PART 149—VOLUNTARY TRICHINAE 

CERTIFICATION PROGRAM 

Sec. 

149.0 Purpose and scope. 

149.1 Definitions. 

149.2 Program participation. 

149.3 Site audit. 

149.4 Spot audit. 

149.5 Offsite identification and segregation 

of certified swine. 

149.6 Slaughter facilities. 

149.7 Recordkeeping at site. 

149.8 Program fees and charges. 

149.9 Pilot program sites. 

Authority: 7 U.S.C. 8301–8317; 7 U.S.C. 

1622; 7 CFR 2.22, 2.80, and 371.4. 

§ 149.0 Purpose and Scope. 

The Trichinae Certification Program 

described in this part is intended to 

enhance the ability of swine producers, 

as well as slaughter facilities and other 

persons that handle or process swine 

from pork production sites that have 

been certified under the program, to 

export fresh pork and pork products to 

overseas markets. 

§ 149.1 Definitions. 

Accredited veterinarian. A 

veterinarian approved by the APHIS 

Administrator in accordance with part 

161 of this chapter to perform functions 

specified in subchapters B, C, D, and G 

of this chapter. 

Agricultural Marketing Service (AMS). 

The Agricultural Marketing Service of 

the United States Department of 

Agriculture. 

AMS Administrator. The 

Administrator, Agricultural Marketing 

Service, or any person authorized to act 

for the AMS Administrator. 

AMS representative. Any individual 

employed by or acting as an agent on 

behalf of the Agricultural Marketing 

Service who is authorized by the AMS 

Administrator to perform services 

required by this part. 

Animal and Plant Health Inspection 

Service (APHIS). The Animal and Plant 

Health Inspection Service of the United 

States Department of Agriculture. 

Animal disposal plan. A written 

document that describes methods for 

the removal and disposal of dead swine 

or swine remains from a pork 

production site. 

Animal movement record. A written 

record of the movement of swine into or 

from a pork production site. 

APHIS Administrator. The 

Administrator, Animal and Plant Health 

Inspection Service, or any person 

authorized to act for the APHIS 

Administrator. 

APHIS representative. Any individual 

employed by or acting as an agent on 

behalf of the Animal and Plant Health 

Inspection Service who is authorized by 

the APHIS Administrator to perform the 

services required by this part. 

Approved laboratory. A non-Federal 

laboratory approved by the Agricultural 

Marketing Service and recognized by 

the APHIS Administrator or FSIS 

Administrator for performing validated 

tests to determine the presence of 

trichinae infection in reference to the 

Trichinae Certification Program. 

Audit. An inspection process, as 

provided in this part, that generates a 

written record documenting a pork 

production site’s adherence to the 

required good production practices. 

Auditor. A qualified accredited 

veterinarian (QAV) or a qualified 

veterinary medical officer (QVMO) who 

is trained and authorized by APHIS to 

perform auditing activities under the 

Trichinae Certification Program. 

Certification (certified). A designation 

given by the APHIS Administrator to a 

pork production site for compliance 

with good production practices and 

other program requirements of the 

Trichinae Certification as provided in 

this part. 

Certified pork. Pork products 

originating from certified swine from a 

certified production site with identity of 

such animals or carcasses maintained 

throughout receiving, handling, and 

processing.1

Certified production site. A pork 

production site that has attained a 

program status of Stage II or higher, 

based on adherence to good production 

practices and other program 

requirements as provided in this part. 

Certified swine. Swine produced 

under the Trichinae Certification 

Program on a certified production site. 

Decertification (decertified). Removal 

of the certified status of a production 

site by the APHIS Administrator when 

it has been determined that the criteria 

of the Trichinae Certification Program 

are not being met or maintained. 

Enzyme-linked immunosorbent assay 

(ELISA). A method of testing swine for 

the presence of trichinae infection by 

looking for antibodies to Trichinella 

spiralis in the sera, plasma, whole 

blood, tissue fluid, or meat juice of 

swine. 

EPA. The United States 

Environmental Protection Agency. 

Feed mill quality assurance affidavit. 

A written statement signed by the feed 

mill representative and the producer 

that documents the quality and safety of 

feed or feed ingredients delivered from 

the feed mill to the pork production site. 

Food Safety and Inspection Service 

(FSIS). The Food Safety and Inspection 

Service of the United States Department 

of Agriculture. 

FSIS Administrator. The 

Administrator, Food Safety and 


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Inspection Service, or any person 

authorized to act for the Administrator. 

FSIS program employee. Any 

individual employed by or acting as an 

agent on behalf of the Food Safety and 

Inspection Service who is authorized by 

the FSIS Administrator to perform the 

services required by this part. 

Good manufacturing practices. Feed 

manufacturing practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. 

Good production practices. Pork 

production management practices that 

reduce, eliminate, or avoid the risk of 

exposure of swine to Trichinella 

spiralis. 

Harborage. Any object, debris, clutter, 

or area that could serve as shelter or 

refuge for rodents or wildlife. 

Laboratory approval audit. An audit 

performed by AMS representatives to 

determine if a laboratory meets 

minimum requirements for approval, as 

established by AMS, for performing 

validated tests under this part. 

National Trichinae Certified Herd. All 

swine raised on certified production 

sites in the United States. 

Person. Any individual, corporation, 

company, association, firm, partnership, 

society, joint stock company, or other 

legal entity. 

Pest control operator. A person 

trained and State-licensed in the control 

of pests and vermin (particularly 

rodents). 

Pooled sample digestion method 

(digestion method). A method of testing 

swine for trichinae infection by 

identifying the presence of Trichinella 

spiralis from a sample of the animal’s 

muscle tissue. 

Pork production site (site). A 

geographically definable area that 

includes pork production facilities and 

ancillary structures under common 

ownership or management systems and 

the surrounding space within a 100-foot 

perimeter of the swine housing and 

feeding areas. 

Positive test result. Outcome of a 

validated test indicating the presence of 

Trichinella spiralis. 

Process-verification testing. Testing of 

a statistically valid sample of swine 

belonging to the National Trichinae 

Certified Herd at the time of slaughter 

using a validated test to verify that the 

adherence to good manufacturing 

practices and good production practices 

is resulting in the absence of Trichinella 

spiralis infection in swine from that 

herd. 

Producer. An individual or entity that 

owns or controls the production or 

management of swine. 

Qualified accredited veterinarian 

(QAV). An accredited veterinarian who 

has been granted an accreditation 

specialization by the APHIS 

Administrator pursuant to § 161.5 of 

this chapter based on completion of an 

APHIS-approved orientation or training 

program in good production practices in 

swine management, and who is 

authorized by the APHIS Administrator 

to perform site audits and other 

specified program services required by 

this part. 

Qualified veterinary medical officer 

(QVMO). A VMO of the State or Federal 

Government who is trained in good 

production practices and is authorized 

by the APHIS Administrator to perform 

site audits, spot audits, and other 

specified program services required by 

this part. 

Rodent control logbook. A written 

record that documents a rodent control 

program for a pork production site. 

Site audit. An audit, performed by a 

QAV or a QVMO, to determine the 

trichinae risk factor status of a pork 

production site based on the site’s 

adherence to all of the required good 

production practices that reduce, 

eliminate, or avoid the risk of exposure 

of swine to Trichinella spiralis. 

Slaughter facility. A slaughtering 

establishment operating under the 

Federal Meat Inspection Act (21 U.S.C. 

601 et seq.) or a State meat inspection 

act that receives certified swine under 

the Trichinae Certification Program. 

Slaughter facility representative. Any 

individual employed by, or acting as an 

agent on behalf of, a slaughter facility 

who is authorized by the slaughter 

facility to perform the specified program 

services required by this part. 

Spot audit. An audit of a certified 

pork production site performed by a 

QVMO to ensure program integrity and 

consistency. 

Stage I enrolled. Preliminary program 

status of a pork production site attained 

when the APHIS Administrator 

approves the outcome of an initial site 

audit. 

Stage II certified. Program status 

attained upon APHIS approval of a site 

audit of a Stage I enrolled site. 

Stage III certified. Program status 

attained upon APHIS approval of a site 

audit of a Stage II certified site and 

maintained upon APHIS approval of 

subsequent site audits for renewal of 

Stage III certified status. 

Sterile zone. An open area 

immediately adjacent to and 

surrounding those building(s) used to 

house and feed swine that serves as both 

a buffer and detection zone for rodent 

and wildlife activity. 

Temporary withdrawal. The voluntary 

withdrawal of a certified production site 

from the Trichinae Certification 

Program at the request of the producer 

for a period not to exceed 180 days. 

Trichinae. A generic term that refers 

to Trichinella spiralis. 

Trichinae Certification Program 

(program). A voluntary pre-harvest pork 

safety program in which APHIS certifies 

pork production sites that follow all of 

the required good production practices 

that reduce, eliminate, or avoid the risk 

of exposure of swine from their sites to 

Trichinella spiralis. 

Trichinae Identification Number 

(TIN). A number assigned to a pork 

production site by the APHIS 

Administrator. 

Trichinella spiralis. A parasitic 

nematode (roundworm) capable of 

infecting many warm-blooded 

carnivores and omnivores, including 

swine. 

USDA. The United States Department 

of Agriculture. 

Validated test. An analytical method 

licensed by APHIS or accepted by AMS 

for the diagnosis of Trichinella spiralis 

in swine. 

Veterinary medical officer (VMO). A 

veterinarian employed by the State or 

Federal Government who is authorized 

to perform official animal health 

activities on their behalf. 

Waste feeding logbook. A written 

record that documents the presence of 

good production practices with respect 

to the feeding of meat-containing waste 

to swine and compliance with 

applicable State and Federal food waste 

feeding laws and regulations. 

§ 149.2 Program participation. 

A producer’s initial enrollment and 

continued participation in the trichinae 

certification program requires that the 

producer adhere to all of the good 

production practices, as confirmed by 

periodic site audits, and comply with 

other recordkeeping and program 

requirements provided in this part. Pork 

production sites accepted into the 

program by APHIS will participate 

under one of the following three 

program stages: 

(a) Stage I enrolled status. (1) Stage I 

enrolled status signifies that the site has 

met good production practices and other 

recordkeeping and program 

requirements provided in this part. 

(2) Swine from a Stage I enrolled site 

cannot be identified as products from a 

certified production site. 

(3) A Stage I enrolled site must 

complete a site audit for Stage II 

certified status in accordance with 

§ 149.3(d). Under § 149.3(d), the site 

audit must be performed no sooner than 

150 days from the date the site was 

awarded Stage I enrolled status, and 

must be completed, with the audit form 


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and payment submitted to APHIS, no 

later than 210 days from the date the 

site was awarded Stage I enrolled status. 

(4) A Stage I enrolled site that is 

found not to be adhering to one or more 

good production practices as a result of 

a site audit or spot audit, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment 

for consideration as a Stage II certified 

site, will lose its status as a Stage I 

enrolled site. 

(b) Stage II certified status. (1) Stage 

II certified status signifies that the site 

is adhering to all of the required good 

production practices and other 

recordkeeping and program 

requirements provided in this part. 

(2) An APHIS-issued certificate or 

letter indicating the site’s status as a 

Stage II certified site must be filed at the 

site and be readily available for 

inspection. 

(3) Swine from a Stage II certified site 

may be identified as certified product 

from a certified production site. 

(4) A Stage II certified site must 

complete a site audit for Stage III 

certified status in accordance with 

§ 149.3(e). Under § 149.3(e), the site 

audit must be performed no sooner than 

240 days from the date the site was 

awarded Stage II certified status, and 

must be completed, with the audit form 

and payment submitted to APHIS, no 

later than 300 days from the date the 

site was awarded Stage II certified 

status. 

(5) A Stage II certified site that is 

found not to be adhering to one or more 

good production practices as a result of 

a site audit or spot audit, or that fails to 

meet the Stage III site audit 

requirements of § 149.3(e) within the 

prescribed timetable, will be decertified 

by APHIS as provided in paragraph (e) 

of this section. During the time a site is 

decertified, swine from that site cannot 

be identified as product from a certified 

production site. 

(c) Stage III certified status. (1) Stage 

III certified status signifies that the site 

is adhering to all of the required good 

production practices and other 

recordkeeping and program 

requirements provided in this part. 

(2) An APHIS-issued certificate or 

letter indicating the site’s status as a 

Stage III certified site must be filed at 

the site and be readily available for 

inspection. 

(3) Swine from a Stage III certified site 

may be identified as certified products 

from a certified production site. 

(4) A Stage III certified site that is 

found not to be adhering to one or more 

good production practices as a result of 

a site audit or spot audit, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment 

to determine its continued participation 

as a Stage III certified site, will be 

decertified by APHIS as provided in 

paragraph (e) of this section. During the 

time a site is decertified, swine from 

that site cannot be identified as product 

from a certified production site. 

(d) Change of ownership. (1) Stage I 

enrolled site. If there is a change in 

ownership in a Stage I enrolled site, and 

the new ownership wishes to remain in 

the program, then the Stage I enrolled 

site will remain on the same timetable 

as under the previous ownership for 

purposes of completing a site audit for 

Stage II certified status. No additional 

site audit is necessary as a result of the 

change of ownership of the site. 

(2) Stage II or Stage III certified sites. 

Within 60 days of a change in 

ownership of a Stage II or Stage III 

certified site, a site audit must be 

performed in order for the site to 

maintain its certified status. It is the 

new ownership’s responsibility that a 

site audit be performed within 60 days 

of the change in ownership, otherwise 

the site will be decertified. If the site 

audit is satisfactory, then the Stage II or 

Stage III certified site will continue in 

the program only as a Stage II certified 

site. A new program anniversary date 

for that site will be established based on 

the date the site was audited to continue 

in the program as a Stage II certified 

site. If the results of the site audit do not 

meet program requirements, as 

determined by APHIS, the Stage II or 

Stage III site will be decertified. Once a 

site is decertified by APHIS, either 

because the new ownership fails to 

arrange for a site audit to be performed 

within the allotted 60-day time period, 

or because the site is found not to meet 

program requirements, a producer 

wishing to participate in the program 

again must follow the procedures for 

requesting an initial audit for Stage I 

enrolled status. If a decertified site is 

reenrolled after a successful Stage I site 

audit, a new program anniversary date 

for that site will be established based on 

the date of reenrollment. 

(e) Site decertification and program 

withdrawal. (1) Decertification by 

APHIS. 

(i) A Stage II or Stage III certified site 

that is found not to be adhering to one 

or more good production practices as a 

result of a site audit or spot audit, or 

that fails to follow the prescribed 

timetable for completing a site audit and 

submitting the completed audit form 

and payment to continue participation 

in the program, will be decertified by 

APHIS. 

(ii) During the time a site is 

decertified, swine from such sites 

cannot be identified as certified product 

from a certified production site. 

(iii) Once a site is decertified by 

APHIS, a producer wishing to 

participate in the program again must 

follow the procedures for requesting a 

site audit for Stage I enrolled status. If 

a decertified site is reenrolled after a 

successful Stage I site audit, a new 

program anniversary date for that site 

will be established based on the date of 

recertification. If a decertified site is 

recertified after a successful Stage II site 

audit, a new program anniversary date 

for that site will be established based on 

the date of recertification. 

(2) Temporary withdrawal by 

producer. (i) A producer may request 

that one or more certified production 

sites be temporarily withdrawn. A 

producer’s request must be made in 

writing and is subject to the APHIS 

Administrator’s approval. 

(ii) Each certified production site can 

be temporarily withdrawn no more than 

once every 2 years for a period not to 

exceed 180 days. 

(iii) During the time a site is 

temporarily withdrawn: 

(A) Swine from such sites cannot be 

identified as certified product from a 

certified production site; and 

(B) The producer must continue to 

adhere to all good production practices 

and other recordkeeping and program 

requirements provided in this part, 

unless specifically waived by the 

Administrator, including 

documentation in the animal movement 

record of the arrival and departure of all 

swine from the site, as well as whether 

the swine arriving at the site are from 

certified or noncertified sources. 

(iv) Before being reinstated as a 

certified production site, the 

temporarily withdrawn site must pass a 

site audit to indicate that it is adhering 

to all good production practices 

(including any practices previously 

waived by the Administrator) as 

follows: 

(A) The site audit must be performed 

while the site is still under temporary 

withdrawal status. If swine 5 weeks of 

age or older originating from 

noncertified sources are received at the 

site during the time of withdrawal, then 

the site audit for reinstatement must be 

performed within 30 days of the date 

the last swine from noncertified sources 

was removed from the site, but no later 

than 180 days from the date the site was 

granted temporary withdrawal status. 

(B) If the results of the site audit are 

satisfactory and it is determined that the 

site is adhering to good production 

practices and other program 


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2Telephone numbers for APHIS area offices can 

be found in local telephone books or on the Internet 

at http://www.aphis.usda.gov/vs/area_offices.htm. 

requirements provided in this part, then 

the withdrawn site will be reinstated as 

a Stage II certified site. The timetable for 

performing future site audits for 

attaining and renewing Stage III 

certified status will be based on the date 

the site was reinstated as a Stage II 

certified site. 

(C) If the results of the site audit are 

not satisfactory due to the producer’s 

failure to adhere to one or more good 

production practices, or, if the period of 

temporary withdrawal has exceeded 180 

days, then the site will be decertified by 

APHIS. Once the site is decertified by 

APHIS, the producer must follow the 

procedures for requesting an initial site 

audit for Stage I enrolled status in order 

for the site to be reenrolled in the 

program. If a site is decertified by 

APHIS and then reenrolled after a 

successful Stage I site audit, a new 

program anniversary date for that site 

will be established based on the date of 

enrollment. 

(3) Program withdrawal. (i) If a 

producer decides to withdraw one or 

more of pork production sites from the 

program, then it is the producer’s 

responsibility to notify the APHIS 

Administrator in writing of this intent. 

When this is done, the site will be 

removed from the program. 

(ii) If at a later date the producer 

requests that a site be reinstated in the 

program, then the producer must follow 

the procedures for requesting an initial 

audit for Stage I enrolled status. If a 

withdrawn site is reenrolled after a 

successful Stage I site audit, then a new 

program anniversary date for that site 

will be established based on the date of 

reenrollment. 

(f) Request for review. If there is a 

conflict as to any material fact relating 

to the results of a site audit, spot audit, 

or other determination affecting a 

producer’s program status or ability to 

participate in the program, the producer 

may submit a written request for review 

to the Administrator. The producer 

must include in the request the reasons, 

including any supporting 

documentation, why the audit result or 

other determination should be different 

than the result or determination made 

by the Administrator. The initial audit 

result or other determination will 

remain in force pending the completion 

of the Administrator’s review. The 

decision by the Administrator upon 

reviewing the producer’s written request 

will be final. 

§ 149.3 Site audit. 

(a) General. (1) The producer must 

contact a QAV to request a site audit. A 

list of available QAVs may be obtained 

by accessing the Trichinae Certification 

Program Web site on the Internet at 

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

or by contacting the APHIS area office.2

If a QAV is not available to perform a 

site audit, the producer may then 

contact the APHIS area office to request 

that a QVMO perform the site audit. The 

site audit is to be arranged at a mutually 

agreed-upon time. 

(2) The producer or the producer’s 

designated representative will 

accompany the auditor during the site 

audit. 

(3) During the site audit, the auditor 

will record whether the producer is 

adhering to all of the required good 

production practices at the site, as 

provided in paragraph (b) of this 

section, in order to reduce, eliminate, or 

avoid the risk of exposure of swine to 

Trichinella spiralis. 

(4) The auditor will use APHISapproved audit forms in performing the 

site audit. After the auditor has 

completed all sections of the audit form, 

the producer or the producer’s 

designated representative must sign the 

audit form attesting to the accuracy of 

the information obtained during the site 

audit and to evidence his or her intent 

to continue adhering to the good 

production practices and other program 

requirements, as provided in this part. 

The auditor also must sign the audit 

form at this time. 

(5) The producer is responsible for the 

cost of each site audit performed at the 

pork production site. If a QAV performs 

the site audit, then the producer will 

pay the QAV directly at a mutually 

agreed-upon time and rate. If a QVMO 

performs the site audit, then the 

producer will pay the QVMO at the time 

the site audit is performed in 

accordance with the rate and other 

conditions set by the QVMO’s 

governmental employer. If an APHISemployed QVMO performs the site 

audit, then the producer will pay APHIS 

by certified check or U.S. money order 

for this service at a rate determined in 

accordance with § 149.8. 

(6) In addition to the cost of the site 

audit, the producer is also responsible 

for paying a separate program fee in an 

amount specified in § 149.8 to cover 

APHIS’ administrative costs in 

processing the audit and operating the 

program. This program fee, payable to 

APHIS by certified check or U.S. money 

order, must be remitted to the auditor at 

the time each site audit is performed. 

(7) The auditor will submit the 

completed audit form, program fee, and 

payment for the services of an APHISemployed QVMO, if applicable, to the 

nearest APHIS area office. If a QAV 

performs the site audit, the producer 

will be responsible for ensuring that the 

QAV submits the completed audit form 

and program fee to APHIS in a timely 

manner. 

(8) Upon receipt of the completed 

audit form and payment, APHIS will 

determine the initial enrollment or 

certification status for the site based on 

an evaluation of the site audit. APHIS 

will provide the producer with written 

notification of the audit results. Pork 

production sites that meet all good 

production practices as provided in 

paragraph (b) of this section, as well as 

other program requirements provided in 

this part, will be issued program status 

at the appropriate program stage. 

(9) If the site audit shows that the site 

does not meet all good production 

practices or other program 

requirements, APHIS will provide the 

producer with written notification that 

includes documentation of the 

deficiencies that prevented the site from 

being conferred program status. 

(b) Good production practices. In a 

site audit, the auditor will determine 

whether all of the required good 

production practices are being carried 

out at the site to reduce, eliminate, or 

avoid the risk of exposure of swine to 

Trichinella spiralis as follows: 

(1) The movement of all non-breeding 

swine 5 weeks of age or older into or 

from the pork production site must be 

documented in an animal movement 

record, as provided in § 149.7, that 

ensures that all such swine moved into 

or from the site can be subsequently 

traced back to that site, or to any 

previous site (if applicable). 

(2) All non-breeding swine entering a 

site must have originated from another 

certified production site, except that 

non-breeding swine less than 5 weeks of 

age may have originated from either a 

certified or noncertified production site. 

The animal movement record must 

include the TIN of the certified 

production site from which the swine 

originated. If the swine are less than 5 

weeks of age and come from a 

noncertified site, then the animal 

movement record must provide the 

name and full address of the 

noncertified site where the swine 

originated. 

(3) Feed or feed ingredients from 

offsite sources that are used at the site 

must meet good manufacturing practices 

or other quality assurance standards 

recognized by the feed industry. The 

adherence to good manufacturing 

practices or other quality assurance 

standards must be documented in a feed 


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3The pre-audit information packet may be 

obtained from a qualified accredited veterinarian 

(QAV), State or Federal animal health offices, or the 

National Pork Board, or by writing to: USDA, 

APHIS, Veterinary Services, Trichinae Certification 

Program, 210 Walnut St., Room 891, Des Moines, 

IA 50309. A pre-audit packet also may be requested 

electronically through the program Web site on the 

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

mill quality assurance affidavit, as 

provided in § 149.7. 

(4) Swine housing and feeding areas, 

feed preparation and storage areas, and 

office areas and connecting hallways at 

the site must be inspected regularly and 

found free of fresh signs rodent and 

wildlife activity. Any movable 

harborage (exterior or interior) on the 

site that is not necessary to the day-today operation of the site must be 

removed. Harborage that cannot be 

removed or is movable but necessary to 

the day-to-day operation of the site (e.g., 

bales of hay, etc.) must be checked for 

signs of rodent or wildlife activity (e.g. 

fresh droppings, tracks, signs of 

gnawing or burrowing). In addition, 

domesticated animals, including pets 

such as dogs and cats, must be excluded 

from the swine housing and feeding 

areas and feed preparation and storage 

areas at the site (evidence of rodent 

activity or rodent infestation consists of 

fresh rodent droppings, fresh gnawing 

marks, new structural damage, rodent 

urine, rodent blood, rodent smear marks 

(body oil), rodent tracks, or recent 

burrowing or burrow use. Evidence of 

wildlife activity consists of wildlife 

feces, footprints, fur, or hair observed in 

or near the stored feed or feed 

ingredients, dead or live wildlife 

observed in or near the stored feed or 

feed ingredients, or wildlife burrows or 

nests observed in or near the stored feed 

or feed ingredients). Exterior rodent bait 

stations and/or traps must be placed 

around the perimeter of those 

building(s) housing the swine, as well as 

around the perimeter of outdoor swine 

feeding areas. Exterior rodent bait 

stations and/or traps also must be 

placed around areas of potential rodent 

entry into building(s) used to house and 

feed swine (i.e., doorways, vent 

openings, loading chutes, cool cells, 

etc.). Interior rodent bait stations and/or 

traps must be placed near high-risk 

rodent zones such as entryways, 

hallways, office areas, swine load out 

areas, vents, cool cells, storage areas, 

utility rooms, cabinets, locker rooms, 

bathrooms, and break rooms, and 

systematically maintained. Interior 

rodent bait stations and/or traps must be 

placed so that swine will not come in 

contact with the bait or trap. Rodent bait 

stations and/or traps also must be 

placed near exterior or interior 

harborage on the site that cannot be 

removed or that is movable but 

necessary to the day-to-day operation of 

the site. In all instances, rodent bait 

stations must be intact, systematically 

maintained, and contain fresh bait that 

consists of an EPA-registered 

rodenticide formulation that is applied 

according to its label. In addition, a 

sterile zone must be maintained around 

the perimeter of those building(s) used 

to house and feed swine. The sterile 

zone must be devoid of any harborage 

or feed or water sources that could 

attract rodents or wildlife, but must 

contain rodent bait stations and/or 

rodent traps. The sterile zone also must 

be devoid of any vegetation unless it is 

decorative vegetation that is well 

maintained (i.e., residential height grass, 

flowers, shrubs, or trees). A sterile zone 

with decorative vegetation will require 

increased rodent control measures. The 

producer must provide documentation 

of rodent control practices by 

maintaining at the site an up-to-date 

rodent control logbook with a site 

diagram and other recordkeeping 

evidencing implementation of rodent 

control measures, which can include 

documents provided by a pest control 

operator, as provided in § 149.7. 

(5) Feed or feed ingredients stored at 

the site must be prepared, maintained, 

and handled in a manner that protects 

the feed or feed ingredients from 

possible exposure to or contamination 

by rodents or wildlife. Any movable 

harborage in the immediate vicinity of 

feed production and feed storage areas 

that is not necessary to the day-to-day 

operation of the site must be removed. 

Harborage that cannot be removed or 

harborage that is movable but necessary 

to the day-to-day operation of the site 

(e.g., bales of hay, etc.) must be checked 

for signs of rodent or wildlife activity. 

Rodent bait stations and/or traps must 

be placed around (and in, if applicable) 

all feed preparation and storage areas, as 

well near any harborage in the vicinity 

that cannot be removed or that is 

movable but necessary to the day-to-day 

operation of the site. Rodent bait 

stations must be intact, systematically 

maintained, and contain fresh bait that 

consists of an EPA-registered 

rodenticide formulation that is applied 

according to its label. In addition, feed 

or feed ingredients that are stored in 

paper bags must be elevated off the floor 

and be a sufficient distance away from 

the walls to allow for inspection, 

baiting, and/or trapping. The rodent 

control logbook, as provided in § 149.7, 

must document that adequate rodent 

control procedures have been 

implemented in the feed production and 

feed storage areas. 

(6) Swine must not have access to 

wildlife harborage or dead or live 

wildlife at the site. This harborage 

limitation includes wood or wooded 

lots and other natural wildlife access 

areas. Dead or live wildlife must not be 

intentionally fed to swine. 

(7) If meat-containing waste is fed to 

swine at the site, then the producer 

must hold a license or permit that 

authorizes the feeding of such waste to 

swine. Cooking times and temperatures 

of meat-containing waste must be 

consistent with applicable State and 

Federal laws and regulations. In 

addition, up-to-date records of waste 

feeding and cooking practices, in the 

form of a waste feeding logbook must be 

maintained at the site, as provided in 

§ 149.7. Cooked food waste products 

that are stored prior to feeding must not 

be mixed or contaminated with 

uncooked or undercooked meat waste 

material. Household food waste, 

regardless of whether it contains meat or 

is cooked or undercooked, also must not 

be fed to swine. 

(8) Procedures must be in place and 

carried out for the prompt removal and 

proper disposal of dead swine or swine 

remains found in pens in order to 

eliminate the opportunity for 

cannibalism, as well as to prevent the 

attraction of rodents or wildlife. Such 

procedures must be documented in the 

animal disposal plan, as provided in 

§ 149.7. 

(9) General hygiene and sanitation of 

the site must be maintained at all times 

to prevent the attraction of rodents and 

wildlife. Solid non-fecal waste (facility 

refuse) must be placed in covered 

receptacles and be regularly removed 

from the site. Spilled feed also must be 

regularly removed and properly 

disposed of. 

(10) All records required under 

§ 149.7 must be kept up-to-date and 

readily available for inspection at the 

site. 

(c) Initial site audit for Stage I 

enrolled status. (1) Producers interested 

in participating in the program should 

request and review a pre-audit 

information packet prepared by APHIS 

that discusses the program, as well as 

the steps in preparing for and requesting 

an initial site audit.3 When the producer 

and the producer’s herd health 

personnel believe that a site meets 

program standards, the producer may 

arrange for an initial site audit, as 

provided in paragraph (a) of this 

section. 

(2) Upon completion of the initial site 

audit and submission of the completed 

audit form and payment, APHIS will 


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review the completed audit form and 

make a determination within 30 days as 

to enrollment of the site in the program. 

A pork production site that is found to 

meet all good production practices and 

other program requirements in this part 

will be awarded Stage I enrolled status. 

(d) Site audit for Stage II certified 

status. (1) A producer of a Stage I 

enrolled site must arrange for another 

site audit for Stage II certified status. 

The site audit must be performed no 

sooner than 150 days (i.e., 

approximately 5 months) from the date 

the site was awarded Stage I enrolled 

status, and must be completed, with the 

audit form and payment submitted to 

APHIS, no later than 210 days (i.e., 

approximately 7 months) from the date 

the site was awarded Stage I enrolled 

status. 

(2) APHIS will review the completed 

audit form and make a determination as 

to Stage II certified status within 7 days 

of receipt of the audit form and 

payment. (i) A Stage I enrolled site that 

is found to meet all good production 

practices and other program 

requirements in this part will be 

awarded Stage II certified status. 

(ii) A Stage I enrolled site that is 

found, during a site audit, not to be 

adhering to one or more good 

production practices, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment, 

will not be awarded Stage II certified 

status and will lose its program status as 

a Stage I enrolled site. 

(e) Site audit for Stage III certified 

status. (1) A producer of a Stage II 

enrolled site must arrange for another 

site audit for Stage III certified status. 

The site audit must be performed no 

sooner than 240 days (i.e., 

approximately 8 months) from the date 

the site was awarded Stage II certified 

status, and must be completed, with the 

audit form and payment submitted to 

APHIS, no later than 300 days (i.e., 

approximately 10 months) from the date 

the site was awarded Stage II certified 

status. 

(2) APHIS will review the completed 

audit form and make a determination as 

to Stage III certified status within 30 

days of receipt of the audit form and 

payment. (i) A Stage II certified site that 

is found to meet all good production 

practices and other program 

requirements in this part will be 

awarded Stage III certified status. 

(ii) A Stage II certified site that is 

found, during a site audit, not to be 

adhering to one or more good 

production practices, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment, 

will be subject to decertification by 

APHIS as provided in § 149.2(e). 

(f) Site audit for renewal of Stage III 

certified status. (1) A producer seeking 

to renew a site’s Stage III certified status 

must arrange for another site audit. The 

site audit must be performed no sooner 

than 14 months from the date the site 

was awarded Stage III certified status or 

the date that status was last renewed, 

and must be completed, with the audit 

form and payment submitted to APHIS, 

no later than 16 months from either the 

date the site was awarded Stage III 

certified status or the date that the status 

was last renewed. 

(2) APHIS will review the completed 

audit form and make a determination as 

to renewing the site’s Stage III certified 

status within 30 days of receipt of the 

audit form and payment. (i) A Stage III 

certified site that is found to meet all 

good production practices and other 

program requirements in this part will 

have its status Stage III certified site 

renewed. 

(ii) A Stage III certified site that is 

found, during a site audit, not to be 

adhering to one or more good 

production practices, or that fails to 

follow the prescribed timetable for 

completing a site audit and submitting 

the completed audit form and payment, 

will be subject to decertification by 

APHIS as provided in § 149.2(e). 

§ 149.4 Spot audit. 

(a) In addition to regularly scheduled 

site audits, certified production sites 

will be subject to spot audits. (1) 

Random spot audit. Certified 

production sites will be selected by the 

APHIS Administrator at random for a 

spot audit in order to: 

(i) Ensure the integrity of the audit 

process; 

(ii) Verify that the audit process is 

performed in a consistent manner across 

the program; and 

(iii) Verify that all required good 

production practices are being 

maintained between regularly 

scheduled site audits. 

(2) Spot audit for cause. A certified 

production site may be subject to a spot 

audit to trace back and investigate any 

positive test results as a result of testing 

of certified swine from that site at the 

slaughter facility. 

(b) All spot audits will be performed 

by a QVMO. The producer of the 

certified production site subject to spot 

audit will not be charged for the spot 

audit. APHIS will provide the producer 

with written notification of the results 

of the spot audit, including 

documentation of any deficiencies 

noted during the audit. If the site is 

found not to be adhering to one or more 

of the required good production 

practices, then the site will be subject to 

decertification by APHIS as provided in 

§ 149.2(e). 

§ 149.5 Offsite identification and 

segregation of certified swine. 

Certified swine moved from a 

certified production site to another 

location, whether to another certified 

production site, buying station, 

collection point, or slaughter facility, 

must remain segregated from 

noncertified swine at all times and 

otherwise maintain their identity as 

certified swine in such a way that they 

could be readily traced back to the 

certified production site from which 

they came. Information relating to the 

identification of the certified swine 

must be documented in the animal 

movement record maintained by the 

producer. Failure to properly segregate 

or maintain the identity of certified 

swine from noncertified swine after 

leaving the certified production site will 

result in the loss of certified status for 

that shipment of swine. 

§ 149.6 Slaughter facilities. 

Only slaughter facilities that are 

under continuous inspection by the 

Food Safety and Inspection Service or 

under State inspection that the Food 

Safety and Inspection Service has 

recognized as equivalent to Federal 

inspection may participate in the 

program. To participate in the program, 

slaughter facilities must follow the 

relevant provisions of this section 

relating to verification, segregation, 

testing, and recordkeeping. Participating 

slaughter facilities that fail to comply 

with any of the applicable requirements 

of this section will not be allowed to 

continue to participate in the Trichinae 

Certification Program and the pork or 

pork products prepared by the facility 

will not be eligible for a certificate of 

export that identifies the product as 

meeting the standards of the Trichinae 

Certification Program. 

(a) Verification of certification. A 

slaughter facility receiving certified 

swine must verify the current 

certification status of the pork 

production site from which the animals 

came. The current certification status 

may be verified by maintaining dated 

certification documentation on file or by 

accessing the Trichinae Certification 

Program Web site on the Internet at 

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

If the slaughter facility is unable to 

verify a site’s certification status 

through documentation on file or 

through the program Web site, the 


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4A copy of the testing methods and checklist for 

conducting validated tests may be obtained by 

contacting the Trichinae Program Manager, USDA, 

AMS, Science and Technology, Technical Services 

Branch, 1400 Independence Avenue, SW., Mail 

Stop 0272, Washington, DC 20250–0272; or by 

telephone at (202) 690–0621. 

5A copy of the AMS Trichinae Accredited 

Laboratory Program Requirements may be obtained 

by contacting the Trichinae Program Manager (see 

footnote 3). 

slaughter facility then should contact 

the APHIS area office in the State where 

the site is located. 

(b) Maintaining identity and 

segregation of certified swine and pork 

products. For certified swine to be 

identified as certified pork, certified 

swine and edible pork products derived 

from certified swine must remain 

segregated from swine and edible pork 

products from noncertified sites 

throughout receiving, handling, and 

processing at the slaughter facility, as 

well as while awaiting shipment from 

the facility. The slaughter facility must 

maintain the identity of the certified 

swine or pork in a manner that allows 

the certified swine or pork to be traced 

back to the certified production site 

from which it came. A slaughter 

facility’s failure to properly segregate or 

maintain the identity of certified swine 

and edible pork products derived from 

the certified swine will result in the loss 

of certified status for that shipment of 

swine, as well as the edible pork 

products derived from those animals. 

(c) Process-verification testing. A 

slaughter facility processing certified 

swine is responsible for performing 

process-verification testing at its 

expense to determine the Trichinella 

spiralis infection status of certified 

swine under its control as follows: 

(1) Validated tests. Processverification testing must be performed 

by using a validated test.4

(2) Laboratory approval. Processverification testing must be performed 

in an approved laboratory that has been 

approved for trichinae testing by the 

Agricultural Marketing Service (AMS).5

The approved laboratory may be 

maintained and operated by the 

slaughter facility or by another business 

entity either on the premises of the 

slaughter facility or at another location. 

Laboratory staff performing processverification testing must be accredited 

by AMS to perform this program 

function. For purposes of quality 

assurance, all laboratory staff approved 

to perform process-verification testing 

will receive periodic proficiency test 

panels from AMS that must be analyzed 

correctly in order to maintain their 

approval status. 

(3) Testing sample size and frequency. 

Process-verification testing must meet 

the following minimum requirements 

relating to sample size and frequency: 

(i) Slaughter facility representatives 

shall determine the yearly processing 

capacity of the slaughter facility for the 

next 12 months. Officials may use the 

processing capacity over the previous 12 

months if this period is representative of 

a typical processing year. 

(ii) Slaughter facility representatives 

shall estimate the percentage of swine 

processed that are likely to come from 

certified production sites considering all 

swine expected to be processed at the 

slaughter facility during the selected 12- 

month period. Swine that come from 

certified production sites are considered 

the eligible population to be sampled. 

(iii) Slaughter facility representatives 

shall use the Trichinae Certification 

Slaughter Facility Sample Size 

Determination Table (see table 1) to find 

the number of samples to collect from 

the population of swine from certified 

production sites. If the eligible 

population is not listed in table 1, the 

next largest number will be used to 

determine the number of samples to 

collect. Select the number of samples to 

collect from the column that reflects a 

99 percent confidence level of detecting 

a positive carcass in the population. The 

number selected from table 1 will be the 

total number of samples that slaughter 

facility representatives must collect and 

test per year and per month during the 

selected 12-month period. 

TABLE 1.—TRICHINAE CERTIFICATION SLAUGHTER FACILITY SAMPLE SIZE DETERMINATION

Certified swine from certified production sites processed per slaughter facility per year 

Samples to collect 

from the population per year at 

a 99 percent 

confidence level 

Samples to collect 

from the population per month 

at a 99 percent 

confidence level 

1,000 ............................................................................................................................................................ 1,000 84 

5,000 ............................................................................................................................................................ 4,996 417 

25,000 .......................................................................................................................................................... 18,938 1,578 

100,000 ........................................................................................................................................................ 29,828 2,486 

200,000 ........................................................................................................................................................ 32,462 2,705 

400,000 ........................................................................................................................................................ 33,899 2,825 

1,000,000 ..................................................................................................................................................... 34,802 2,900 

2,000,000 ..................................................................................................................................................... 35,110 2,926 

4,000,000 ..................................................................................................................................................... 35,266 2,939 

5,000,000 ..................................................................................................................................................... 35,297 2,942 

(iv) For each sample collected, 

slaughter facility representatives must 

maintain the identity of the sample 

using the TIN of the certified production 

site that was the source of the swine 

from which the sample was taken. 

(v) FSIS program employees at the 

slaughter facility will review and verify 

that an adequate number of samples 

have been collected and that proper 

frequency of collection is maintained. 

FSIS will report this information to 

APHIS. 

(vi) AMS representatives will verify 

through a laboratory approval audit that 

the laboratory performing processverification testing is correctly following 

written procedures relating to the 

receipt, handling, identification, and 

testing of samples. These written 

procedures must be maintained by the 

laboratory in a quality assurance 

manual, as provided in paragraph (c)(6) 

of this section. In addition, a laboratory 

that performs process-verification 

testing at a location other than the 

slaughter facility must include a 

declaration of methodology used to test 

samples when providing test results. 

(vii) The APHIS Administrator may, 

at APHIS’ expense, periodically request 

that testing be performed on swine 

brought to the slaughter facility from 

specific certified production sites. 

Requests to test swine from specific 

certified production sites will count 

towards the slaughter facility’s total 

monthly testing requirement. 


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(4) Results of testing. (i) The results of 

all process-verification testing relating 

to certified swine handled at the 

slaughter facility must be retained in a 

separate file or notebook as written 

records at the slaughter facility and 

must be readily available for inspection 

by FSIS program employees. 

(ii) FSIS will report to APHIS the 

results of all process-verification testing. 

(iii) In the event of a positive test 

result, the slaughter facility 

representative must notify the FSIS 

program employee designated by the 

FSIS Administrator immediately, who 

in turn will report the TIN of the 

certified production site that was the 

source of the swine from which the 

sample was taken and the test results of 

the affected sample to the respective 

APHIS area office. The following 

sequence of events must take place 

following a positive test result: 

(A) If a test sample yields a positive 

test result based on the digestion 

method, the certified production site 

that was the source of the swine from 

which the sample was taken will be 

decertified. 

(B) If a test sample yields a positive 

test result based on an ELISA method 

and is confirmed positive by further 

testing using the digestion method, the 

certified production site that was the 

source of the swine from which the 

sample was taken will be decertified. 

(C) If a test sample yields a positive 

test result based on an ELISA method, 

but is not confirmed positive by further 

testing using the digestion method, then 

the certified production site that was the 

source of the swine from which the 

sample was taken will be investigated 

by APHIS. 

(1) The investigation may include a 

spot audit of the affected site. Further 

testing of animals or carcasses from the 

affected site also may be performed as 

part of the investigation. This 

investigation would determine if the 

production facility has sufficient 

safeguards and is following good 

production practices. 

(2) While the affected site is under 

investigation, its program status as a 

certified production site will be 

suspended. While the site is under 

suspension, the producer must continue 

to adhere to all of the required good 

production practices and other 

recordkeeping and program 

requirements provided in this part; 

however, swine from the suspended site 

cannot be identified as product from a 

certified production site. The 

Administrator will determine the 

program status of the affected site 

within 30 days of the initiation of the 

suspension. 

(3) A finding that risk factors are 

inadequately addressed in the site 

investigation or the finding of additional 

positive test results based on samples 

from animals or carcasses from the 

affected site will be grounds for APHIS 

decertification of the site. 

(5) Slaughter facility recordkeeping. 

(i) All slaughter facilities that receive 

certified swine must maintain records 

relating to such animals, including the 

number of certified swine processed, the 

source of the certified swine, including 

the TIN of the certified production site 

from which the swine came from, and 

all test results relating to processverification testing. Records relating to 

certified swine must be retained at the 

slaughter facility for a period of at least 

3 years following the processing of such 

animals. 

(ii) All slaughter facilities must have 

documented procedures on how 

certified swine under its control, and 

edible pork products derived from 

certified swine, will remain segregated 

from swine and edible pork products 

from noncertified sites throughout 

receiving, handling, and processing at 

the facility, as well as while awaiting 

shipment from the facility. The 

slaughter facility must also have 

documented procedures for maintaining 

the identity of the certified swine or 

pork with respect to the certified 

production site from which it came. 

(iii) All such records and other 

documentation required to be 

maintained by slaughter facilities under 

this part must be readily available for 

inspection by FSIS program employees. 

(6) Approved laboratory 

recordkeeping. Approved laboratories 

must have written procedures that 

specify standards for sample size, 

sample handling, sample identification, 

and sample test methods used in 

process-verification testing. All such 

written procedures must be maintained 

in a laboratory quality assurance manual 

specifically for this program, or as a 

separate section of an existing 

laboratory quality assurance manual, 

and must be retained at the approved 

laboratory throughout the time the 

approved laboratory is performing 

process-verification testing under this 

program. All such written procedures 

relating to process-verification testing 

must be readily available for inspection 

by FSIS program employees or AMS 

representatives. 

(7) Slaughter facility overall 

responsibility for process-verification 

testing. The slaughter facility is 

responsible for obtaining testable 

samples and for ensuring that the 

correct number of testable samples are 

sent to the testing laboratory. Once the 

slaughtering facility receives the test 

results, it is responsible for reporting 

those results in its facility trichinae 

testing record. Moreover, the slaughter 

facility is responsible for ensuring that 

process-verification testing is carried 

out in accordance with this part, 

including the reporting of test results, 

regardless of whether it is performed at 

the slaughter facility or another 

location, and regardless of whether the 

testing is performed by slaughter facility 

personnel or other persons. 

§ 149.7 Recordkeeping at site. 

(a) Stage I enrolled sites, Stage II or 

Stage III certified sites, and any site that 

has been suspended or voluntarily 

decertified must maintain the following 

program records: Animal disposal plan, 

animal movement record, feed mill 

quality assurance affidavit (if 

applicable), rodent control logbook, and 

waste feeding logbook (if applicable). 

All such records must be readily 

available for inspection at the pork 

production site at the time of an audit 

by a QAV or QVMO, or by other APHIS 

representatives during normal business 

hours. 

(1) Animal disposal plan. The animal 

disposal plan must meet the following 

minimum requirements: 

(i) It must provide for the removal of 

all dead swine or swine remains from 

swine pens immediately upon 

detection. Inspections for purposes of 

detecting dead animals must occur at 

least once every 24 hours. 

(ii) It must specify how often and at 

what intervals the swine pens are 

observed each day. 

(iii) It must provide for the proper 

storage of dead swine or swine remains 

in accordance with local, State, and 

Federal laws and regulations. If the 

carcass storage facility or composting 

facility is located on the site, then the 

animal disposal plan must provide for a 

storage or composting facility that 

precludes rodent or wildlife contact 

with dead swine or swine remains being 

stored or composted. 

(iv) It must provide for the disposal of 

swine and other mammals by rendering, 

incineration, composting, burial, or 

other means, as allowed by and in 

accordance with local, State, and 

Federal laws and regulations. For sites 

that use rendering services, the animal 

disposal plan also must include the 

name, address, and phone number of 

the renderer. 

(v) It must be updated as animal 

disposal practices are changed at the 

site. 

(vi) It must be signed and dated by the 

producer, as well as the caretaker of the 


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site (if the caretaker is a different person 

than the producer). 

(vii) It may be valid for a period no 

longer than 2 years after the date of 

signature by the producer and (if 

applicable) the site caretaker. 

(2) Animal movement record. The 

animal movement record must meet the 

following minimum requirements: 

(i) It must be filled out completely 

and properly, accounting for the 

movement of all non-breeding swine 

into and from the pork production site. 

(ii) In the case of non-breeding swine 

coming into the site, it must include the 

date and number of arriving animals, as 

well as the TIN of the certified 

production site where the animals 

originated, or alternatively, if the swine 

are less than 5 weeks of age and 

originated from a noncertified site, the 

name and full address of the 

noncertified site where the animals 

originated. The animal movement 

record must clearly document that all 

non-breeding swine 5 weeks of age or 

older arriving at the site originated from 

another certified production site. 

(iii) In the case of non-breeding swine 

leaving the site, it must include the date 

and number of departing animals, and 

their destination. 

(iv) It must document the number of 

dead non-breeding swine that are 

removed from the site, as well as the 

number of dead non-breeding swine that 

are buried or composted at the site, if 

swine burial or composting is permitted 

in that State or locality. 

(v) All entries to the animal 

movement record must be signed or 

initialed and dated by the producer or 

other site caretaker making the entry. 

(3) Rodent control logbook. The 

rodent control logbook, which may 

include records from a pest control 

operator, must meet the following 

minimum requirements: 

(i) It must include a rodent control 

diagram for the site indicating the 

location of all rodent bait stations and 

rodent traps at the site. The diagram 

must be updated whenever bait stations 

are added, moved, or removed. 

(ii) It must document the number of 

rodent traps set (if applicable), the 

number of new rodent bait stations set, 

and how often bait is refreshed. 

(iii) It must document the disposal 

method for all unused bait that is 

replaced. 

(iv) It must document the brand name 

and active ingredient of bait, which 

must be EPA registered and applied 

according to its label, as well as the 

quantity of bait used (number of 

pounds). 

(v) If possible, it should document the 

number of rodents caught or killed and 

indicate how many were rats. 

(vi) If possible, it should document 

the number of rats sighted monthly. 

(vii) All entries to the rodent control 

logbook must be signed or initialed, as 

well as dated by the producer or other 

site caretaker making the entry. It must 

be updated at least monthly. 

(4) Feed mill quality assurance 

affidavit. The feed mill quality 

assurance affidavit, to be used in 

conjunction with feed or feed 

ingredients delivered to the pork 

production site, must meet the 

following minimum requirements: 

(i) It must include the name of the 

producer and the identity of the site, 

including the TIN if it has been issued, 

and the site address, as well as the name 

and address of the feed mill and the 

name and title of the feed mill 

representative. 

(ii) It must provide that the feed mill 

is following good manufacturing 

practices, and further specify, as 

evidence of these good manufacturing 

practices, the following: 

(A) That the feed mill has a rodent 

control system that is maintained by the 

feed mill itself or by a pest control firm 

(include name and address of pest 

control firm). 

(B) The frequency with which such 

rodent control system is maintained 

(i.e., on a weekly basis, etc.); and 

(C) That the feed mill maintains 

records of pest management practices or 

has records generated by a pest control 

operator, which must be made available 

to the producer upon request. 

(iii) It must be signed by the feed mill 

representative and by the producer or 

the producer’s designated 

representative, to remain in effect for a 

period of 2 years. 

(5) Waste feeding logbook. If the 

producer feeds meat-containing food 

waste to swine at the site, the producer 

must maintain a waste feeding logbook 

that meets the following minimum 

requirements: 

(i) It must include the name of the 

producer and the identity of the site, 

including the TIN if it has been issued, 

the site address, and the number of the 

license or permit authorizing the 

feeding of such waste to swine. 

(ii) It must be kept up-to-date with 

documentation evidencing adherence to 

applicable State and Federal food waste 

feeding laws and regulations. 

(iii) It must provide information as to 

the method used in cooking the meatcontaining food waste. 

(iv) For each batch of meat-containing 

food waste cooked, it must record the 

batch number (if applicable to the 

operation), the temperature at which 

such food waste is cooked and the 

length of time it is held at that 

temperature, and the method for 

verifying the temperature and length of 

time cooked. 

(v) For each batch of meat-containing 

food waste cooked, it must document 

the sources of meat. 

(vi) It must evaluate and document on 

at least a monthly basis the level of 

sanitation of the site, taking into 

account the following factors: 

(A) Whether garbage containers are 

clean and covered with lids; 

(B) Sanitation of cooking area and 

equipment; 

(C) Sanitation of feeding areas and 

waste disposal; 

(D) Sanitation of storage areas; 

(E) Rodent control system around 

equipment, storage, and feeding areas; 

(F) Sanitation of waste hauling trucks 

or containers; 

(G) Access of other animal species to 

food waste (wild animals, dogs, cats, 

etc.); and 

(H) The potential for crosscontamination between cooked product 

and raw meat-containing food waste. 

(vii) All entries to the waste feeding 

logbook must be signed or initialed, as 

well as dated, by the producer or other 

site caretaker making the entry. 

(b) All such records and other 

documentation required under this 

section must be retained at the pork 

production site for a period of 2 years. 

(c) All such records and other 

documentation required under this 

section must be readily available for 

inspection at the pork production site at 

the time of an audit by a QAV or 

QVMO, or by other APHIS 

representatives during normal business 

hours. 

§ 149.8 Program fees and charges. 

(a) Site audit. The producer is 

responsible for the cost of each site 

audit performed at the pork production 

site. 

(1) If a QAV performs the site audit, 

then the producer will pay the QAV 

directly at a mutually agreed-upon time 

and rate. 

(2) If a QVMO performs the site audit, 

then the producer will pay the QVMO 

at the time the site audit is performed 

in accordance with the rate and other 

conditions set by the QVMO’s 

governmental employer. Further, if the 

QVMO who performs the site audit is 

employed by APHIS, then the producer 

will pay APHIS for this service at the 

hourly rate listed in table 2 for each 

employee required to perform the 

service. If the APHIS-employed QVMO 

performs the site audit on a Sunday, on 


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1For further information on accreditation 

specializations, including training requirements 

and fees, contact the National Veterinary 

Accreditation Program, VS, APHIS, 4700 River 

Road Unit 46, Riverdale, MD 20737, phone (301) 

734–6188. 

a holiday, or at any time outside the 

normal tour of duty of that employee, 

then the producer will pay APHIS for 

this service at the hourly rate listed in 

table 3 for each employee required to 

perform the service. Payment to APHIS 

for the services of an APHIS-employed 

QVMO, by certified check or U.S. 

money order, must be remitted to the 

QVMO at the time the site audit is 

performed. 

TABLE 2.—RATES FOR SERVICES OF

QVMO 

Beginning 

Oct. 1, 2003 

Hourly rate: 

Per hour ......................... $84.00 

Per quarter hour ............ 21.00 

Per service minimum fee 25.00 

TABLE 3.—OVERTIME RATES FOR

SERVICES OF QVMO (OUTSIDE THE

EMPLOYEE’S NORMAL TOUR OF

DUTY) 

Beginning 

Oct. 1, 2003 

Premium hourly rate Monday 

through Saturday and holidays: 

Per hour ......................... $100.00 

Per quarter hour ............ 25.00 

Premium hourly rate for Sundays: 

Per hour ......................... 112.00 

Per quarter hour ............ 28.00 

(b) Program fee. The producer must 

pay APHIS a program fee at the time of 

each site audit in the amount of $51 to 

cover APHIS’ administrative costs in 

processing the audit and operating the 

program. This program fee, payable to 

APHIS by certified check or U.S. money 

order, is due at the time of submitting 

the completed site audit form for APHIS 

evaluation. 

(c) A producer will not be charged for 

the cost of having a spot audit 

performed at the pork production site. 

§ 149.9 Pilot program sites. 

Pork production sites participating in 

an APHIS-approved trichinae pilot 

program at the time of implementation 

of the Trichinae Certification Program 

on [effective date of final rule] will 

maintain their same program status as 

either a Stage I enrolled, Stage II 

certified, or Stage III certified site, as 

well as their same program anniversary 

date for purposes of completing a site 

audit and submitting the completed 

audit form and payment. 

PART 160—DEFINITION OF TERMS 

3. The authority citation for part 160 

would continue to read as follows: 

Authority: 7 U.S.C. 8301–8317; 15 U.S.C. 

1828; 7 CFR 2.22, 2.80, and 371.4. 

4. In § 160.1, a new definition would 

be added, in alphabetical order, for 

qualified accredited veterinarian (QAV) 

to read as follows: 

§ 160.1 Definitions. 

* * * * * 

Qualified accredited veterinarian 

(QAV). An accredited veterinarian who 

has been granted an accreditation 

specialization by the Administrator 

pursuant to § 161.5 of this subchapter 

based on completion of an APHISapproved orientation or training 

program. 

* * * * * 

PART 161—REQUIREMENTS AND 

STANDARDS FOR ACCREDITED 

VETERINARIANS AND SUSPENSION 

OR REVOCATION OF SUCH 

ACCREDITATION 

5. The authority citation for part 161 

would continue to read as follows: 

Authority: 7 U.S.C. 8301–8317; 15 U.S.C. 

1828; 7 CFR 2.22, 2.80, and 371.4. 

6. Section 161.5 would be added to 

read as follows: 

§ 161.5 Specialization. 

An accreditation specialization 

recognized by the Administrator may be 

granted to an accredited veterinarian 

upon completion of an orientation or 

training program approved by APHIS. 

For certain accredited specializations, 

the cost of orientation or training may 

be borne by the accredited veterinarian. 

An accredited veterinarian granted an 

accreditation specialization will be 

referred to as a qualified accredited 

veterinarian or QAV. A QAV will be 

authorized to perform those activities 

and functions specifically provided for 

elsewhere in this chapter, for example, 

in part 149.1

Done in Washington, DC, this 7th day of 

May 2007. 

Bruce Knight, 

Under Secretary for Marketing and Regulatory 

Programs. 

[FR Doc. E7–9236 Filed 5–15–07; 8:45 am] 

BILLING CODE 3410–34–P 


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