Trichinae Certification Program, 27656-27686 [E7-9236]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Proposed Rules]
[Pages 27656-27686]
From the Federal Register Online via the Government Printing 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:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0089 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0089, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0089.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://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,

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no further contamination can occur. Animals that are infected with 
trichinae are at least partially resistant to a subsequent infection 
due to a strong and persistent immunity.
    Trichinae may be passed on to humans who consume undercooked meat 
infected with the encysted parasite. Humans who are infected with the 
parasite generally experience 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:
     Do not feed uncooked waste products, table scraps, or 
animal carcasses to swine. This is particularly important in the case 
of carcasses from hunted or trapped wildlife.
     Eliminate or minimize the exposure of swine to live 
wildlife. Create barriers that are effective in separating swine from 
skunks, raccoons, and other small mammals.
     Implement and maintain an effective rodent control program 
at the pork production site. Biosecurity, maintaining perimeters, 
baiting, and trapping are all part of rodent control.
     Maintain good hygiene at the pork production site. Remove 
dead swine as soon as they are found. Keep barns free from clutter and 
store feed securely.

Trichinae Control

    Despite the relatively low prevalence of trichinae in swine in many 
developed countries, considerable energy goes into preventing human 
exposure to this parasite. There are a variety of ways in which 
trichinae control is approached. A number of countries require 
slaughter testing of each carcass. In fact, for pork exported to the 
European Union (EU), packers in the United States test carcasses using 
the same methods employed by European meat inspectors. While the need 
for such measures may no longer seem as immediate, given that trichinae 
is almost nonexistent in U.S.-produced pork, it is apparent that some 
organized approach to demonstrating product safety is still needed for 
overseas markets. The following discussion summarizes the potential 
methods that are currently used for trichinae control.

Slaughter Testing

    Many countries require slaughter testing of each carcass. Such 
testing is largely a continuation of measures implemented when 
trichinae was a serious problem. In many countries, slaughter 
inspection programs are required.
    Approved slaughter testing methods for trichinae in swine include 
direct methods for visualization of parasites. Since it is not possible 
to see trichinae cysts within meat tissue by macroscopic examination, 
it is necessary to perform one of several laboratory tests. The oldest 
method, and one still frequently used, is called the compression 
method. Small pieces of pork collected from the pillars (crus muscle or 
hanging tenderloin) of the diaphragm are compressed between two thick 
glass slides (a compressorium) and examined microscopically for the 
presence of Trichinella spiralis larvae.
    An improvement over the compression method, and a method that is 
now widely used in Europe, is the pooled sample digestion method. 
Samples of tissue collected from sites where parasites concentrate, 
such as the diaphragm, masseters, or tongue, are subjected to digestion 
in acidified pepsin. Larvae, which are freed from their muscle cell 
cysts by this process, are recovered by a series of settling steps, 
then visualized and counted under a microscope. Requirements for 
performing the digestion test are found in the Directives of the 
European Economic Community, in the FSIS regulations in 9 CFR 
318.10(e), and in various other publications.
    Another method of testing swine for trichinae infection is an 
indirect method that looks for antibodies to the parasites in swine 
sera, plasma, whole blood, tissue fluid, or meat juice. The 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:
     Accredited veterinarians trained in good production 
practices relative to exposure to trichinae work with producers to 
ensure that trichinae risk factors are reduced, eliminated, or avoided 
at pork production sites;
     The site audit performed by trained USDA-accredited 
veterinarians serves as a method to document that risks of infection 
are eliminated or satisfactorily controlled. Audits need to be done 
periodically to ensure that good production practices relative to 
trichinae control remain in place;
     On a regular basis, a statistically valid sample of the 
total number of swine from certified production sites is tested at the 
slaughter facility laboratory or some other onsite or offsite 
laboratory using licensed or accepted testing methods to verify the 
absence of trichinae infection; and
     QVMOs perform random ``spot audits'' of certified 
production sites to ensure the overall integrity and consistency of the 
program.
    The regular site audit takes into account those management 
practices that affect the risk of exposure of swine to trichinae, such 
as feed integrity (i.e., source and storage), building construction and 
condition as it pertains to biosecurity, integrity of rodent control 
programs, and general management and hygiene factors as they pertain to 
rodent control, swine cannibalism, and other issues. As a part of the 
process of raising swine under good production practices, the producer 
needs to maintain certain records that document its adherence to good 
production practices, with those records being verified in the site 
audit. The producer also is responsible for adhering to good production 
practices between site audits.
    A pilot program for the certification of pork production sites as 
being produced under the requirements of the Trichinae Certification 
Program that involved the above-mentioned agencies of USDA, as well as 
private industry, was conducted in Iowa, Minnesota, and South Dakota in 
1997 and 1998. The purpose of the pilot program was to evaluate a 
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.

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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\
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    \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 https://
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 https://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:
     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.''
     All non-breeding swine entering a site would have to have 
originated from another certified production site, except that non-
breeding swine less than 5 weeks of age may have originated from a 
certified or noncertified production site. We would provide this 
exception because swine less than 5 weeks of age do not as yet eat 
solid food, and therefore do not present a risk of ingesting the 
Trichinella spiralis parasite through infected food sources. The animal 
movement record would have to include the TIN of the certified 
production site from which the swine originated. If the swine are less 
than 5 weeks of age and come from a noncertified site, then the animal 
movement record would have to provide the name and full address of the 
noncertified site where the swine originated.
     Feed or feed ingredients from offsite sources that are 
used at the site would have to meet all good manufacturing practices or 
other quality assurance standards recognized by the feed industry. The 
adherence to good manufacturing practices or other quality assurance 
standards would have to be documented in a feed mill quality assurance 
affidavit. Additional information relating to the feed mill quality 
assurance affidavit is provided below under the heading ``Recordkeeping 
at Site.''
     Swine housing and feeding areas, feed preparation and 
storage areas, and office areas and connecting hallways at the site 
would have to be inspected regularly and found free of fresh signs of 
rodent and wildlife activity. Any movable rodent harborage (exterior or 
interior) on the site that is not necessary to the day-to-day operation 
of the site would have to be removed. Harborage that cannot be removed 
or is movable but necessary to the day-to-day operation of the site 
(e.g., bales of hay, etc.) would have to be checked for signs of rodent 
or wildlife activity. In addition, domesticated animals, including pets 
such as dogs and cats, would have to be excluded from the swine housing 
and feeding areas and feed preparation and storage areas at the site. 
Evidence of rodent activity or rodent infestation would consist of 
fresh rodent droppings, fresh gnawing marks, new structural damage, 
rodent urine, rodent blood, rodent sm