[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Proposed Rules]
[Pages 27656-27686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9236]



[[Page 27655]]

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Part VI





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Parts 149, 160, and 161



 Trichinae Certification Program; Proposed Rule

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

[[Page 27656]]


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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.

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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:
    <bullet> 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.
    <bullet> 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 egg-transmitted, 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,

[[Page 27657]]

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 flu-like 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-to-eat 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 enzyme-
linked 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:
    <bullet> 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;
    <bullet> 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;
    <bullet> 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
    <bullet> 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 
process-verification 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 Sec.  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 Sec.  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.

[[Page 27660]]

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\
---------------------------------------------------------------------------

    \1\ The 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.
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    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 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 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

[[Page 27661]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  149.3(e), a Stage II certified site must complete a site audit 
for Stage III certified status. Under Sec.  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 Sec.  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 Sec.  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 Sec.  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.

[[Page 27662]]

    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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  149.3 would contain more specific information on 
performing site audits. Proposed Sec.  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.

[[Page 27663]]

General

    Proposed Sec.  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 agreed-upon 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 Sec.  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 Sec.  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 Sec.  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\
---------------------------------------------------------------------------

    \2\ FSIS and AMS would not charge any additional program fees 
for the site audit, however, FSIS does charge $15 for export 
certificates.
---------------------------------------------------------------------------

    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]
----------------------------------------------------------------------------------------------------------------
                                                                              Hourly
                                                               Number of    salary (FY    Benefits      Direct
                                                                 hours         05)        @24.26%    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      ...........  ...........  ...........      $51.00
     whole dollar...........................................
----------------------------------------------------------------------------------------------------------------
\2\ Includes time to review the application, compare to standards, identify any nonconformities, call the
  auditor (if necessary), approve/deny application, and sign.
\3\ GS 5/step 5 clerk (includes time to process and file paperwork, identify auditing veterinarian, and perform
  data entry).
\4\ GS 11/step 5 inspector (includes time for spot audits).


[[Page 27664]]

    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 Sec.  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:
    <bullet> 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 Sec.  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.''
    <bullet> 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.
    <bullet> 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.''
    <bullet> 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 EPA-registered 
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 Sec.  149.7. Additional 
information relating to the rodent control logbook is provided below 
under the heading ``Recordkeeping at Site.''
    <bullet> 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

[[Page 27665]]

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 EPA-registered 
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 Sec.  149.7, would have to 
document that adequate rodent control procedures have been implemented 
in the feed production and feed storage areas.
    <bullet> 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.
    <bullet> 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 Sec.  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.)
    <bullet> 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 Sec.  149.7. Additional information relating to 
the animal disposal plan is provided below under the heading 
``Recordkeeping at Site.''
    <bullet> 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.
    <bullet> All records required under proposed Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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.

[[Page 27666]]

    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 
Sec.  149.2(e).

Site Audit for Renewal of Stage III Certified Status

    Proposed Sec.  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 Sec.  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 Sec.  149.4.
    The APHIS Administrator would select certified production sites at 
random for a spot audit in order to:
    <bullet> Ensure the integrity of the auditing process;
    <bullet> Verify that the audit process is performed in a consistent 
manner across the program; and
    <bullet> 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 Sec.  
149.2(e).

Offsite Identification and Segregation of Certified Swine

    Under proposed Sec.  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 Sec.  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 Sec.  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 ``Process-Verification 
Testing of Certified Swine.''
Verification of Certification
    Proposed Sec.  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 Sec.  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

[[Page 27667]]

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 Sec.  149.6(c) would require slaughter facilities handling 
and processing certified swine from certified production sites to carry 
out process-verification testing at their expense in order to determine 
the Trichinella spiralis infection status of those animals. Under 
proposed Sec.  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 Sec.  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 process-verification 
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 Sec.  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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> AMS representatives would verify through a laboratory 
approval audit that the laboratory performing process-verification 
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 Sec.  
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.
    <bullet> 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 Sec.  149.6(c)(4) would cover the requirements with regard 
to the handling of test results. We would require that the results of 
process-verification 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 27668]]

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 Sec.  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 Sec.  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 process-verification testing also would have to 
be readily available for inspection by FSIS program employees or AMS 
representatives.
    Proposed Sec.  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 Sec.  149.7 would cover recordkeeping requirements for 
producers participating in the program. Under proposed Sec.  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:
    <bullet> 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.
    <bullet> Specify how often and at what intervals the swine pens are 
observed each day.
    <bullet> 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.
    <bullet> 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.
    <bullet> Be updated as animal disposal practices are changed at the 
site.
    <bullet> 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).
    <bullet> 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:
    <bullet> Be filled out completely and properly, accounting for the 
movement of all non-breeding swine into and from the pork production 
site.
    <bullet> 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.
    <bullet> In the case of non-breeding swine leaving the site, 
include the date and number of departing animals, and their 
destination.
    <bullet> 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.
    All entries to the animal movement record would have to be signed 
or

[[Page 27669]]

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:
    <bullet> 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.
    <bullet> Document the number of rodent traps set (if applicable), 
the number of new rodent bait stations set, and how often bait is 
refreshed.
    <bullet> Document the disposal method for all unused bait that is 
replaced.
    <bullet> 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).
    <bullet> If possible, document the number of rodents caught or 
killed and indicate whether they are mice or rats.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> Be kept up-to-date with documentation evidencing adherence 
to applicable State and Federal food waste feeding laws and 
regulations.
    <bullet> Provide information as to the method used in cooking the 
meat-containing food waste.
    <bullet> 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.
    <bullet> For each batch of meat-containing food waste cooked, 
document the sources of meat.
    <bullet> 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 meat-containing 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
APHIS-employed 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.

[[Page 27670]]

    In addition to the cost of the site audit, proposed Sec.  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 Sec.  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 Sec.  149.9, pork production sites that are 
participating in an APHIS-approved 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 Sec.  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 Sec.  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 Sec.  161.5 on 
specializations for accredited veterinarians. Under proposed Sec.  
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 Sec.  161.5, the Administrator of APHIS would grant 
the status of qualified accredited veterinarian or QAV to those 
accredited veterinarians who complete an APHIS-approved orientation or 
training program covering that particular specialization. Therefore, an 
accredited veterinarian who completes the APHIS-approved 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

[[Page 27671]]

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.
----------------------------------------------------------------------------------------------------------------
1 Assumes site audit and program fees for attaining both Stage I Enrolled and Stage II Certified status during
  year 1.
2 Site audit and program fees for moving from Stage II to Stage III Certified status.
3 Site audit and program fees for renewal of Stage III Certified status.
4 Experience 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

[[Page 27672]]

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\
---------------------------------------------------------------------------

    \3\ These 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.
---------------------------------------------------------------------------

    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

[[Page 27673]]

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/ 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 EU-approved 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.
---------------------------------------------------------------------------

    \4\ Testing 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.
---------------------------------------------------------------------------

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

[[Page 27674]]

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 on-
farm 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
------------------------------------------------------------------------
                                                         Average annual
  Percentage of sites that would incur no additional   cost per pig over
   costs, minimal GPP costs, or moderate GPP costs          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

[[Page 27675]]

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:
    <bullet> A description of the reasons why action by the agency is 
being considered;
    <bullet> A succinct statement of the objectives of, and legal basis 
for, the proposed rule;
    <bullet> A description of and, where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
    <bullet> 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;
    <bullet> An identification, to the extent practicable, of all 
relevant Federal rules which may duplicate, overlap or conflict with 
the proposed rule;
    <bullet> 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,

[[Page 27676]]

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).

[[Page 27677]]

    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.


Sec.  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.


Sec.  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\
---------------------------------------------------------------------------

    \1\ The 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.
---------------------------------------------------------------------------

    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

[[Page 27678]]

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 Sec.  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.


Sec.  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 Sec.  149.3(d). Under Sec.  
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

[[Page 27679]]

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 Sec.  149.3(e). Under Sec.  
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 Sec.  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

[[Page 27680]]

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.


Sec.  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\ 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.
---------------------------------------------------------------------------

    (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 APHIS-approved 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 APHIS-employed 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 
Sec.  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 
Sec.  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 APHIS-employed 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 Sec.  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

[[Page 27681]]

mill quality assurance affidavit, as provided in Sec.  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-to-day 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \3\ The 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.
---------------------------------------------------------------------------

    (2) Upon completion of the initial site audit and submission of the 
completed audit form and payment, APHIS will

[[Page 27682]]

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 Sec.  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 Sec.  149.2(e).


Sec.  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 Sec.  149.2(e).


Sec.  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.


Sec.  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

[[Page 27683]]

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. Process-verification testing must be performed 
by using a validated test.\4\
---------------------------------------------------------------------------

    \4\ A 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.
---------------------------------------------------------------------------

    (2) Laboratory approval. Process-verification 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 
process-verification 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.
---------------------------------------------------------------------------

    \5\ A copy of the AMS Trichinae Accredited Laboratory Program 
Requirements may be obtained by contacting the Trichinae Program 
Manager (see footnote 3).
---------------------------------------------------------------------------

    (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
----------------------------------------------------------------------------------------------------------------
                                                                                Samples to         Samples to
                                                                             collect from the   collect from the
  Certified swine from certified production sites processed per slaughter     population per     population per
                             facility per year                                 year at a 99      month at a 99
                                                                                 percent            percent
                                                                             confidence level   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 process-verification 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.

[[Page 27684]]

    (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 
process-verification 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.


Sec.  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

[[Page 27685]]

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 meat-containing 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 cross-contamination 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.


Sec.  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

[[Page 27686]]

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.


Sec.  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 Sec.  160.1, a new definition would be added, in alphabetical 
order, for qualified accredited veterinarian (QAV) to read as follows:


Sec.  160.1  Definitions.

* * * * *
    Qualified accredited veterinarian (QAV). An accredited veterinarian 
who has been granted an accreditation specialization by the 
Administrator pursuant to Sec.  161.5 of this subchapter based on 
completion of an APHIS-approved 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:


Sec.  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\
---------------------------------------------------------------------------

    \1\ For 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.

    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