[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Rules and Regulations]
[Pages 60464-60488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23678]



[[Page 60463]]

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Part IV





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; Final Rule

Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / 
Rules and Regulations

[[Page 60464]]


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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: Final rule.

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SUMMARY: We are amending the regulations to establish a voluntary 
Trichinae Certification Program for U.S. pork that has been produced 
under disease-prevention conditions. Under the program, we will certify 
pork production sites that follow prescribed good production practices 
that reduce, eliminate, or avoid the risk of exposure of swine to 
zoonotic parasites of the genus Trichinella. Such a program should 
enhance the ability of producers to export pork and pork products to 
overseas markets. This program has been developed as a cooperative 
effort by the U.S. Department of Agriculture, the National Pork Board, 
and the pork processing industry. This program will 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: Effective Date: November 10, 2008.

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

    Trichinella are parasitic nematodes (roundworms) that are found in 
many warm-blooded carnivores and omnivores, including swine. There are 
eight known species of Trichinella nematodes: Trichinella britovi, 
Trichinella murrelli, Trichinella nativa, Trichinella nelsoni, 
Trichinella papuae, Trichinella pseudospiralis, Trichinella spiralis, 
and Trichinella zimbabwensis. Trichinae is a generic term that refers 
to all species of Trichinella.
    Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), 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 tribal authorities, or other persons in the 
administration of regulations for the improvement of livestock and 
livestock products.
    Under the Agricultural Marketing Act of 1946 (7 U.S.C. 1622, AMA), 
the Administrator of APHIS has authority with respect to voluntary 
inspection and certification of animal products and the inspection, 
testing, treatment, and certification of animals.
    In a proposed rule \1\ published in the Federal Register on May 16, 
2007 (72 FR 27656-27686; Docket No. APHIS-2006-0089), we proposed to 
establish regulations for a Trichinae Certification Program in 9 CFR 
part 149. We stated that the 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 spp. In the proposed 
rule, we also set forth requirements in the same part for the 
systematic monitoring and testing of products derived from pigs that 
originate from certified sites at slaughter facilities, and proposed 
certain changes to 9 CFR parts 160 and 161 covering the accreditation 
of veterinarians and veterinary medical officers that are needed for 
the Trichinae Certification Program.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0089.
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    We solicited comments concerning our proposal for 60 days, ending 
July 16, 2007. We received comments from five commenters by that date. 
They were from two organizations representing the U.S. swine industry, 
one organization representing exporters of U.S. meat products, one 
organization representing U.S. veterinarians, and a private citizen. 
They are discussed in the sections below by topic.

General Comments on the Proposed Rule

    One commenter stated that the proposed program should be mandatory, 
rather than voluntary. The commenter suggested that, under a voluntary 
program, slaughter facilities that do not adhere to production 
practices and biological security measures that are adequate to 
preclude the transmission of trichinae from or to swine will not 
participate, and thus will not be subject to sanitary inspections. The 
commenter stated that, without mandatory inspections, such sites 
present a significant risk of spreading trichinae both to the 
surrounding swine population and to consumers of pork products.
    The purpose of the Trichinae Certification Program is to facilitate 
producers' access to foreign markets by providing them with a means to 
certify their products as produced under conditions that reduce, 
eliminate, or avoid the risk of exposure of swine to zoonotic parasites 
of the genus Trichinella. The sanitary measures and site audits 
stipulated by the proposed rule are necessary for the program to be 
considered adequate by the foreign markets for which the program is 
intended. As such, these sanitary measures and audits supplement, but 
do not replace, existing Food Safety and Inspection Service (FSIS) 
regulations mandating the inspection of slaughter facilities. These 
existing regulations include 9 CFR 302.1, which requires most 
facilities, with limited exemptions, to be inspected by FSIS; 9 CFR 
309.1, which mandates ante-mortem inspections of most livestock; and 9 
CFR 310.1, which mandates post-mortem inspections of carcasses at 
slaughter facilities. APHIS regards these existing regulations to be 
sufficient to mitigate the extremely low risk of pork products infected 
with trichinae being sold to domestic or foreign consumers.
    Another commenter suggested that we combine the provisions of this 
program with the Agricultural Marketing Service's (AMS') Pork for the 
European Union (EU) program, which requires producers to engage in 
process-verification testing.
    We are making no changes in response to this comment. The Trichinae 
Certification Program is intended to facilitate the exportation of 
fresh pork and pork products to all international markets, not only 
those within the EU. Because countries outside of the EU sometimes have 
requirements for process-verification testing and the importation of 
pork products that differ from those of the EU, combining the two 
programs might not facilitate the access of domestic producers to those 
countries' markets.
    However, in this final rule, we are making a number of changes to 
the provisions of the program in order to better align them with the 
existing standards of the EU. These changes are discussed below in the 
section entitled ``Comments Regarding the Rule's Consistency with EU 
Standards.''

[[Page 60465]]

    Noting that we used ``trichinae'' throughout the proposed rule as a 
general term to refer to the nematode Trichinella spiralis, one 
commenter suggested that the term more accurately applies to all 
species of Trichinella nematodes, and we should therefore replace all 
references to Trichinella spiralis with Trichinella spp. The commenter 
suggested that this would not alter the scope of the program, which 
aims to reduce, eliminate, or avoid the risk of exposure of swine to 
all Trichinella species, not just Trichinella spiralis.
    We agree with this commenter. We did not include the other species 
of Trichinella in our proposal only because of their current rarity or 
non-existence in the United States. Accordingly, we are removing all 
occurrences of the words ``Trichinella spiralis'' in the regulatory 
text and adding ``Trichinella spp.'' in their place. The other sections 
of this final rule also reflect this change.
    Finally, one commenter suggested that, once this final rule is 
published, APHIS should coordinate with the pork and meat-processing 
industries to draft a program standards document to help producers 
better understand and participate in the program.
    We intend to produce such a document, as well as an auditor's 
handbook, after the publication of this rule.

Comments Regarding the Rule's Consistency With EU Standards

    Several commenters stated that certain provisions of the proposed 
rule were inconsistent with the standards that the EU has developed for 
its own trichinae control program. A commenter pointed out that, while 
the proposed rule's provisions would allow facilities with outdoor 
swine feeding areas to take part in the program, annex 4(1)(A)(j) of 
``Commission Regulation (EEC) No. 2075/2005 of 5 December 2005 laying 
down specific rules on official controls for Trichinella in meat'' 
forbids certified swine from having any outdoor access.
    Another commenter stated that allowing swine that are fed meat-
containing food waste to participate in our program would be 
inconsistent with the standards of other countries. The commenter did 
not explicitly cite any conflicting international standards. However, 
only one such standard exists. Articles 22(1)(a-b) of ``European 
Community Regulation (EEC) No 1774/2002 of 3 October 2002 laying down 
health rules concerning animal by-products not intended for human 
consumption'' forbid any animal from being fed processed proteins from 
the bodies of members of its own species and forbid farm animals, other 
than fur animals, from being fed certain types of meat-containing 
waste.
    Both of these commenters suggested that such discrepancies may 
impede the EU's recognition of the program, and thus hinder our ability 
to achieve the stated aim of the proposed rule: 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 
foreign markets. Accordingly, the commenters suggested that we forbid 
outdoor production facilities from participating in the program, remove 
provisions allowing swine at production facilities to be fed meat-
containing waste, and generally reevaluate the proposed rule for 
consistency with the standards of the EU.
    In response to these comments, we have undertaken such a 
reevaluation. We have determined that the inclusion of outdoor 
production facilities or facilities with outdoor feeding areas within 
the program is indeed inconsistent with the standards of the EU, and 
that such inclusion may impede the ability of the program to facilitate 
the exportation of fresh pork and pork products to overseas markets. 
Therefore, we have changed the regulations to exclude such facilities 
from participating in the Trichinae Certification Program. As a result, 
in this final rule, only pork production facilities that feed and house 
pigs in enclosed structures, known as confinement units, may 
participate in the Trichinae Certification Program. Such confinement 
units, which are already employed by more than half the pork production 
sites in the United States, including all of the pork production sites 
participating in an APHIS-approved trichinae pilot program, and which 
currently account for the majority of domestic pork production, are 
constructed in a manner to preclude swine from having outdoor access, 
to limit the exposure of swine to wildlife and birds, and to limit 
swine's contact with carrion.
    As a result of this change:
    <bullet> We now include a definition of confinement unit in Sec.  
149.1 of the regulations. We are defining a confinement unit as ``a 
structure on a pork production site in which swine are housed and fed 
that is totally roofed and that is constructed in such a manner as to 
prevent swine from being exposed to free-flying birds and other 
wildlife, and from coming into contact with the carrion of free-flying 
birds or other wildlife.'' This definition is generally consistent with 
the definition of confinement unit that is provided in existing State 
regulations governing pork production facilities.
    <bullet> In Sec.  149.1, in the definitions of pork production site 
and sterile zone, we have removed references to ``the swine housing and 
feeding areas'' and ``those buildings used to house or feed swine'' and 
added ``the confinement unit'' in their place.
    <bullet> In Sec.  149.3, paragraph (b)(4) now specifies that swine 
at the site must be housed and fed in a confinement unit. In that same 
paragraph, we have removed all references to ``swine housing and 
feeding areas,'' ``buildings housing the swine,'' and ``building(s) 
used to house and feed swine,'' and have added the words ``confinement 
unit'' in their place. We have also removed a reference to ``outdoor 
swine feeding areas.''
    <bullet> In the same section, paragraph (b)(6) now reads as 
follows: ``Swine must not have access to dead or live wildlife at the 
site. Dead or live wildlife must not be intentionally fed to swine.'' 
In the proposed rule, the paragraph had also prohibited swine from 
having access to wildlife harborage, including wooded lots and other 
natural wildlife access areas. That prohibition would have been 
necessary for outdoor production sites and production sites without 
confinement units, and thus it is not necessary to include it in this 
final rule.
    We have determined that proposed provisions that would have allowed 
swine to be fed meat-containing waste products are also inconsistent 
with EU standards, and may impede the ability of the program to 
accomplish its stated purpose. Therefore, we have removed the following 
provisions:
    <bullet> In Sec.  149.1, the proposed definition waste feeding 
logbook has been removed. Such a logbook is no longer necessary.
    <bullet> In Sec.  149.3, paragraph (b)(7), which as proposed would 
have allowed swine to be fed meat-containing waste at a certified 
production site, now reads as follows: ``Swine at the site must not be 
fed waste that contains meat.''
    <bullet> In Sec.  149.7, the introductory text of paragraph (a) no 
longer refers to a ``waste feeding logbook.'' In the same section, we 
have removed paragraph (a)(5), which would have established 
requirements for a waste feeding logbook.
    Two commenters stated that, while the proposed rule stipulates that 
slaughter facility representatives must collect and test enough samples 
of swine from a certified production site to achieve a 99 percent 
confidence level of

[[Page 60466]]

detecting trichinae if it exists in a certified herd based on a 
prevalence of 0.013 percent, the EU's trichinae regulations require 
testing sufficient to achieve a 95 percent confidence level in a sample 
population. One of these commenters stated that a 99 percent confidence 
level is therefore unnecessary, and that the confidence level ought to 
be lowered to 95 percent.
    The provisions of this program align with EU standards to the 
greatest extent possible. However, because the program is voluntary, we 
expect both the number of swine that could be tested under process-
verification testing, and, accordingly, the number that actually will 
be tested to differ from those of the EU. Thus, adhering to a 99 
percent confidence level provides an additional degree of assurance to 
our trading partners that the standards of the Trichinae Certification 
Program are sufficiently rigorous, and does not impose a significantly 
greater amount of process verification testing on a participating 
slaughter facility than the adoption of a 95 percent confidence level 
would. If we were to adopt a 95 percent confidence level, a facility 
that slaughters 5,000 certified swine annually would have to conduct 
testing on 9 fewer samples yearly than it would in order to achieve a 
99 percent confidence level, and a facility that slaughters 1 million 
certified swine annually would have to test 5,291 fewer samples yearly. 
In addition, we have determined that process-verification testing under 
the provisions of the Trichinae Certification Program will cost, at 
most, approximately $1.72 per swine. Thus, the adoption of a 95 percent 
confidence level, as opposed to a 99 percent confidence level, would 
not result in a large difference in the annual cost of process-
verification testing for a slaughter facility that participates in the 
program, relative to the total annual cost of process-verification 
testing for that facility.
    Moreover, by requiring a 99 percent confidence level, we are taking 
into account the degree of uncertainty that exists regarding the 
current or future prevalence of trichinae within the U.S. herd. If 
prevalence rates are, in fact, lower than our estimated 0.013 percent, 
or some day become lower than 0.013 percent, then the level of testing 
that we now consider to represent a 99 percent confidence level may, in 
fact, represent or come to represent a lower confidence level. This is 
important, because we believe that the maintenance of at least a 95 
percent confidence level, regardless of fluctuations in prevalence 
rates, represents a threshold for our trading partners' recognition of 
our program. For this reason, we consider the possible benefits derived 
from maintaining a 99 percent confidence level, as opposed to a 95 
percent level, to be greater than the costs associated with attaining 
that higher confidence level. Therefore, we are making no change to the 
rule to lower that level.
    Finally, as a result of our reevaluation of the provisions of the 
Trichinae Certification Program in light of EU standards, we have 
determined that slaughter facilities that conduct process-verification 
testing involving meat within the Trichinae Certification Program must 
obtain testing samples of at least 20 grams. The proposed rule did not 
mandate the size of testing samples.
    As a result, in Sec.  149.6, paragraph (c)(1) now reads as follows: 
``Process-verification testing must be performed by using a validated 
test. When testing involves meat, the sample used for such testing must 
be at least 20 grams.''

Comments Regarding the Scope of the Program

    In Sec.  149.0, ``Purpose and scope,'' we state that the purpose of 
the Trichinae Certification Program is to enhance the ability of 
domestic 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 foreign markets.
    One commenter suggested that we should widen the scope of the 
program to include the possible use of the program for domestic 
marketing purposes. Conversely, another commenter expressed concern 
that the program could result in domestic products being labeled for 
certification of freedom from trichinae or for compliance with program 
standards, and suggested that such marketing could have an adverse 
effect on producers who do not participate in the program.
    Although we recognize that producers may wish to participate in the 
program for domestic marketing purposes, such uses are currently 
outside the scope of our proposed provisions, as we noted by including 
a statement about the limited scope and purpose of the program in the 
regulations. We acknowledge that the Administrator of APHIS has 
authority under the AMA with respect to voluntary inspection and 
certification of animal products and the inspection, testing, 
treatment, and certification of animals. At this time, however, the 
intent of our rule is to establish a program that will enhance the 
ability of domestic 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 foreign markets. Any amendments to the scope of 
the program to include a domestic marketing aspect would be undertaken 
in a separate rulemaking.
    We recognize, moreover, that we referred to the labeling of pork 
products once in the regulatory text of the proposed rule. In our 
proposed definition of certified pork, footnote 1 stated that the 
labeling of all pork products leaving a slaughter or processing 
facility must comply with 9 CFR 317.4 and all other applicable FSIS 
labeling regulations.
    However, we did not intend the footnote as an endorsement of the 
labeling of pork products destined for domestic or international 
markets as certified under the Trichinae Certification Program. Rather, 
we wished to emphasize that the labeling of pork products, whether 
conducted in conjunction with the Trichinae Certification Program or 
otherwise, falls under the purview of FSIS, rather than APHIS, and must 
comply with FSIS regulations. Recognition of such a label as an 
official label would need to occur through a separate regulatory 
action.

Comments Regarding Stage I Status

    In Sec.  149.2(a) of the proposed rule, we stated that once we 
initially accept a producer into the certification program, we will 
award the production site Stage I enrolled status. This stage signifies 
that a qualified accredited veterinarian (QAV) or qualified veterinary 
medical officer (QVMO) has performed a site audit of the facility and 
found it to adhere to the good production practices set forth in Sec.  
149.3(b), as well as any additional recordkeeping and program 
requirements. This stage also signifies that APHIS has received the 
completed audit form and the program fee of $51 from the producer. A 
producer awarded Stage I status is acknowledged to be participating in 
the certification program, but cannot identify swine originating from 
his or her site as certified products from a certified production site; 
we are only allowing Stage II and Stage III sites that have passed 
subsequent site audits to identify their products as certified products 
from a certified production site. Without such identification, pork 
products from the site may not undergo process-verification testing at 
a participating slaughter facility, and a certificate of export 
identifying the products as being from the Trichinae Certification 
Program may not be issued.

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    One commenter suggested that the $51 program fee for producers 
seeking Stage I status is insufficient, and will ultimately force APHIS 
to request a larger budget allocation in order to offset the losses 
generated by the program. Conversely, another commenter pointed out 
that producers who took part in the pilot programs assumed all costs 
for obtaining and maintaining compliance with program standards, and 
would likely be unwilling to pay program fees following implementation 
of this rule. The commenter stated that, instead of imposing a program 
fee, APHIS should operate the program out of federally appropriated 
funds.
    In the proposed rule, we itemized and evaluated the pro rata costs 
associated with the pilot program. These costs included those incurred 
in providing direct and support labor for the pilot program, estimated 
agency overhead, and departmental charges. We then divided this number 
by the total number of applications that had been processed within the 
pilot program at the time and determined that a $51 program fee, 
assessed each time a site audit is performed within the Trichinae 
Certification Program, would be sufficient to cover our administrative 
costs in processing the audit and operating the program.
    However, we do recognize that this fee represents our best 
estimation of the probable costs associated with processing audit forms 
and administering the program at the time our evaluation took place, 
fiscal year (FY) 2005. Therefore, we have reviewed the fee to determine 
whether it needs to be adjusted for FY 2008 and FY 2009. As a result of 
this review, and using the same methodology to arrive at the fee as we 
did in the proposed rule, we have determined that a program fee of $ 51 
should cover costs associated with the program in both fiscal years.
    We note, moreover, that APHIS regularly reviews all fees that we 
assess for our programs and, if necessary, undertakes rulemaking to 
amend them. In accord with this practice, we intend to review the 
program fee yearly based on the date of the initial implementation of 
the program, beginning in FY 2010, and will initiate rulemaking each 
time we need to change it.
    Another commenter stated that, by not allowing producers with Stage 
I enrolled status to identify their swine as certified products or 
identify their facility as a certified production site, we are limiting 
the program's ability to immediately facilitate the exportation of 
fresh pork and pork products to overseas markets. In the commenter's 
estimation, if the program is operational, but pork products shipped 
overseas lack identifiable certification of freedom from trichinae, it 
may take foreign markets several years to formally acknowledge the 
program. To expedite access to those markets, the commenter suggested 
that the first sites awarded Stage I status should be considered 
certified and allowed to immediately begin process-verification testing 
at participating slaughter facilities.
    Section 149.9 of this final rule states that those sites that have 
been participating in an APHIS-approved trichinae pilot program at the 
time of implementation of the Trichinae Certification Program will 
maintain their same program status as Stage I, Stage II, or Stage III 
certified sites. Thus, pork production sites that obtained certified 
status within a pilot program will be allowed to immediately identify 
their swine as certified products from a certified production site 
within the program. This provision addresses the commenter's concern.
    In addition, we regard the provisions of the rule precluding Stage 
I enrolled sites from immediately identifying their products as 
certified and engaging in process-verification testing to be necessary 
for us to determine whether such sites are able to adhere to the good 
production practices, recordkeeping, and program requirements specified 
by this rule over a sufficient period of time before obtaining 
certification. Removing these provisions could impede our ability to 
adequately assess such adherence, and thus adversely affect the 
integrity of the program. Specifically, before a site audit takes place 
for Stage I status within the program, APHIS has no assurance that the 
site has been adhering to the good production practices of the 
Trichinae Certification Program up to the point of the audit, and must 
take into consideration the possibility that swine at the site were 
produced at one point of their lives under standards at variance with 
program standards. Under the provisions of the program, any such swine 
would be sent to slaughter in most circumstances before the site was 
eligible for Stage II certified status.

Comments Regarding a Change in Ownership of a Certified Production Site

    In Sec.  149.2(d) of the proposed rule, we described a protocol for 
producers to follow in the event that there is a change of ownership in 
a site participating in the program. If there is a change in ownership 
to a Stage I enrolled site, the site will continue to operate on the 
same timetable as under the previous ownership for completing a site 
audit for Stage II certified status. If there is a change in ownership 
at a Stage II or Stage III certified site, a site audit must be 
performed on that site within 60 days of the change of ownership. If 
the site audit is satisfactory, the site will continue in the program 
only as a Stage II certified site. A Stage III site that has reverted 
to a Stage II site because of a change of ownership will be subject to 
another site audit within 10 months' time; if that audit is 
satisfactory, we will issue the site a new program anniversary date as 
a starting date for the purposes of performing future audits. If the 
results of any site audit arising from a change of ownership are not 
satisfactory, we may decertify the site, and the site will have to 
reapply for Stage I enrolled status.
    One commenter pointed out that these provisions appear to apply 
only to a change of ownership of a participating production site. The 
commenter asked whether a change in ownership of a herd at a production 
site, without a change in ownership of the site itself, would be 
subject to a similar protocol.
    The provisions are intended to apply to site ownership, not herd 
ownership. If the ownership of the certified site remains the same, and 
site audits continue to confirm the facility's adherence to the good 
production practices stipulated by this rule, the ownership of the 
swine at the facility may change without triggering the need for the 
additional audits and other measures described in Sec.  149.2(d).
    The same commenter asked which party assumes responsibility for 
notifying APHIS of this change in ownership of the facility.
    The outgoing owner of the facility will notify APHIS of the change 
in ownership. Once such notification has occurred, the new owner will 
arrange for a site audit, provided that this new owner wishes to remain 
within the Trichinae Certification Program. Without such an audit, the 
site may be subject to decertification, in accordance with Sec.  
149.2(e)(1). We have amended Sec.  149.2(d)(2) to reflect this 
clarification.

Comments Regarding Site Decertification and Renewal

    In proposed Sec.  149.2(e)(1), we stated that 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. During the 
time a site is decertified, swine from that site cannot

[[Page 60468]]

be identified as certified product from a certified production site. 
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.
    One commenter stated that late payment or an incomplete audit form 
should not result in decertification of a production site. Instead, the 
commenter suggested that we should work with producers to address these 
errors before assessing a penalty, since such errors will usually be 
clerical in nature.
    The same commenter agreed that violations of the good production 
practices should provide a basis for decertification in certain 
instances, but stated that we should make a distinction between 
substantive violations and minor infractions. The commenter suggested 
that we could differentiate between violations based on whether they 
can easily be rectified.
    We believe decertification would be an appropriate response to 
substantive violations of good production practices as well as 
prolonged or repeated failures to observe the program's recordkeeping 
requirements or timetable for submitting forms and payment.
    However, we do recognize that there will be instances of violations 
that are minor, inadvertent, and easily rectified, and that violations 
of that nature should not necessarily lead to decertification in all 
cases. Therefore, we have amended Sec.  149.2(e)(1) to read as follows: 
``A Stage II or Stage III certified site that is found not to be 
adhering to one or more of the good production practices as a result of 
a site 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 subject to a 
review by APHIS to consider the nature of the infraction(s) and to 
determine whether the site should be decertified. Decertification will 
result from infraction(s) that APHIS determines to be substantive, 
prolonged, and/or repeated as a result of this review.''
    To reflect this change, we have also amended Sec. Sec.  149.2, 
149.3, and 149.4 to provide that APHIS will conduct a review to 
consider the nature of possible infractions of the good production 
practices or administrative requirements associated with the program 
before decertifying a production site.
    We are, however, retaining the provisions in the proposed rule that 
stated that if a test sample obtained at a slaughter facility from a 
certified swine yields positive test results based on the pooled 
digestion method of detecting trichinae, or based on the ELISA method 
as corroborated by the digestion method, we would decertify the 
production site that was the source of the swine from which the sample 
was taken.

Comments Regarding Procedures for a Request for Review

    In proposed Sec.  149.2(f), we stated that, if there is a conflict 
as to any material fact relating to the results of a site audit, spot 
audit, or other determination affecting the 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.
    One commenter pointed out that, under the terms of the proposed 
rule, APHIS is responsible both for decertifying a site and for 
evaluating the request for review. The commenter stated that this may 
present or give the appearance of presenting a conflict of interest, 
and asked that we amend the rule to have another party evaluate each 
request for review.
    We are making no change in response to this comment. The review 
process contained in the rule is intended not as a judicial process, 
but as an opportunity for producers to present information to the 
Administrator that may help to determine whether the initial decision 
was in error. Therefore, it is reasonable that APHIS should be 
responsible both for decertification and review of our determination.
    We have used such a process within other certification and approval 
programs that we administer, and have found it to provide an effective 
means of review.

Comments Regarding Good Production Practices

    In Sec.  149.3(b) of the proposed rule, we set forth good 
production practices that producers must adhere to in order to 
participate in the program.
    Proposed paragraph (b)(2) stated that all non-breeding swine 5 
weeks of age or older that enter a certified site must have originated 
from another certified production site, and the animal movement record 
between sites must include the trichinae identification number (TIN) of 
the certified production site from which the swine originated.
    Observing our reference to a TIN, and noting that we defined the 
TIN as ``a number assigned to a pork production site by the APHIS 
Administrator,'' two commenters asked whether the premises 
identification number (PIN) assigned to sites that register their 
premises for APHIS' National Animal Identification System (NAIS) could 
take the place of the TIN. The commenters stated that the TIN and PIN 
appear to serve identical functions, that there is broad support for 
premises registration within the swine industry, and that the use of an 
alternate identification system within the certification program may 
confuse producers who already have a PIN. Accordingly, the commenters 
suggested that we allow producers who already have a PIN to use this 
instead of the TIN and that we add a field to our NAIS premises 
registration forms and our National Premises Identification Repository 
(NPIR) to allow a producer to identify his or her premises as 
participating in the Trichinae Certification Program.
    On December 19, 2007, APHIS issued the NAIS Business Plan to 
Advance Animal Disease Traceability (announced at 72 FR 71871-
71873).\2\ This document recommended strategies and actions that would 
enable existing State and Federal regulated and voluntary animal health 
programs, industry-administered management and marketing programs, and 
various animal identification methods to work in harmony in the NAIS. 
One of the strategies stated that APHIS will standardize data elements 
within all APHIS-administered disease programs by using the PIN as the 
unique location identifier for these programs. Accordingly, each 
producer who enrolls in the Trichinae Certification Program will be 
issued a PIN. We have amended the regulatory text in this final rule to 
reflect this change.
---------------------------------------------------------------------------

    \2\ The Business Plan is available on the Internet at http://animalid.aphis.usda.gov/nais/.
---------------------------------------------------------------------------

    In addition, while the data entry fields in the NPIR are not 
configured in a way that would allow the association requested by the 
commenter, we are exploring whether other databases maintained by 
APHIS' National Center for Animal Health Programs can recognize a 
producer's certified status within the program and associate it with 
other data elements. We will provide notice in a future iteration of 
the program standards if such recognition and association become 
possible.
    Paragraphs (b)(4) and (b)(5) of proposed Sec.  149.3 described 
measures to be taken to prevent infestations by

[[Page 60469]]

wildlife and rodents, including requirements for the use of rodent bait 
stations. In both paragraph (b)(4) and (b)(5), we stated that all such 
rodent bait stations must be intact, systematically maintained, and 
contain fresh bait that consists of an Environmental Protection Agency 
(EPA)-registered rodenticide formulation that is applied according to 
its label.
    Noting the requirements for the use of EPA-registered rodenticides 
as part of the good production practices, one commenter asked whether 
APHIS had taken into account a notice that EPA published in the Federal 
Register on January 17, 2007 (72 FR 1992-1993; Docket No. EPA-HQ-OPP-
2006-0955; FRL-E104-7) that announced the availability of a proposed 
mitigation decision restricting the use of several rodenticides 
currently on the market. The commenter asked us to evaluate both the 
possible increased cost and decreased efficacy of rodenticides as a 
result of this decision.
    On May 28, 2008, EPA released its final decision, titled ``Risk 
Mitigation Decision for Ten Rodenticides.'' \3\ In it, EPA decided not 
to restrict the use or otherwise alter the efficacy of these 
rodenticides, but instead decided upon sale and distribution 
limitations on the products to limit their use in residential settings. 
EPA's final decision contained an evaluation of the potential economic 
impacts of these limitations for poultry and livestock producers, and 
determined that these limitations would not change the availability of 
the rodenticides for such producers.
---------------------------------------------------------------------------

    \3\ To view this document, go to http://www.epa.gov/pesticides/reregistration/rodenticides/rodenticides_mitigation_decision.pdf.
---------------------------------------------------------------------------

    Finally, one commenter asked us to consider the use of bird-
proofing shields as an additional good production practice. The 
commenter suggested that the use of such barriers would prevent pigs 
from exposure to carrion, would add another safeguard to promote rodent 
control, and would further prevent swine's contact with wildlife.
    As noted previously, this final rule provides that only pork 
production sites that house and feed pigs in confinement units may 
participate in the Trichinae Certification Program. All confinement 
units are constructed so as to prevent the exposure of swine to free-
flying birds, wildlife, and carrion.

Comments Regarding Renewal of Stage III Certified Status

    In Sec.  149.2(c) of the proposed rule, we stipulated that sites 
that achieve Stage III certified status will be subject to subsequent 
site audits to determine continued participation in the program. In 
Sec.  149.3(f), we stated that such site audits must be performed no 
sooner than 14 months, and no later than 16 months, from either the 
date the site was awarded Stage III status or the date of the last 
renewal. If, as a result of any of these renewal audits, we determine 
that the site is not adhering to one or more of the good production 
practices, the site will be subject to decertification.
    We received two comments regarding these paragraphs. The commenters 
agreed that the first few renewals should occur at intervals of 14 to 
16 months, but stated that subsequent audits for recertification should 
occur less frequently. One of the commenters stated that the change in 
frequency should occur after 5 years of successful recertification 
audits, and that the intervals should increase at that point to no less 
than 28 months and no more than 32 months. The other commenter 
suggested that the change should occur after the second successful 
renewal, and that all subsequent audits should be conducted at a 
maximum of 30-month intervals. The commenters suggested that making 
site audits less frequent should reduce the cost of the program and 
thus facilitate producer participation, yet would not alter it in a 
manner that could have a negative impact on the domestic perception or 
international recognition of our standards.
    We consider it necessary for at least the first four renewal audits 
to take place at 14- to 16-month intervals. Such intervals will ensure 
that, over time, each Stage III site is audited for adherence to the 
good production practices at least once during each major period for 
receiving and rendering swine during the calendar year, and, 
eventually, during each season within the calendar year. This is 
important, because each season of the year presents producers with 
unique climatic and environmental conditions, e.g., ground cover during 
the winter or the increased presence of rodents during the harvest 
seasons, that can make adherence to the good production practices 
difficult, and that auditors must be able to assess in determining a 
producer's ongoing adherence to those practices.
    Increasing the time between subsequent audits while the Trichinae 
Certification Program is still in its initial implementation may 
adversely impact the program's credibility, and hinder it from 
accomplishing its stated goal.
    However, as the program gains acceptance within the United States 
and is reviewed by export partners, the intervals between such audits 
will be reviewed. If we deem longer intervals to be appropriate at that 
time, we may initiate rulemaking to change them.

Comments Regarding Process-Verification Testing

    In proposed Sec.  149.6(c), we stated that slaughter facilities 
processing certified swine are responsible for performing process-
verification testing at their expense in order to determine the 
Trichinella spp. infection status of certified swine under their 
control. In proposed Sec.  149.6(c)(2), we stated that all testing must 
be performed in a laboratory that has been approved for trichinae 
testing by AMS. We further stated that the laboratory may be maintained 
and operated by the slaughter facility or by another business entity, 
and may be at the slaughter facility or offsite, but that, regardless 
of its location, the laboratory staff performing the tests must be 
approved by AMS, and will be subject to periodic proficiency test 
panels from AMS that will have to be analyzed correctly in order to 
maintain approved status.
    One commenter asked for clarification regarding the process AMS 
employs to approve a laboratory, the cost of this initial approval and 
any subsequent audits/recertification, the possibility of combining 
such audits and recertification with other programs administered by 
AMS, the causes of decertification or withdrawal of approval of a 
laboratory or its personnel, the procedure for recertification, and the 
ramifications for deviations from standard operating procedures for the 
laboratory.
    Slaughter facilities and other business entities interested in more 
information regarding the AMS approval process for process-verification 
testing laboratories should contact the AMS Trichinae Analyst and 
Laboratory Certification Program Manager. All correspondence should be 
addressed to the AMS Trichinae Analyst and Laboratory Certification 
Program Manager, USDA, AMS, Science and Technology Programs, Technical 
Services Branch, 1400 Independence Ave., SW., Mail Stop 0272, 
Washington, DC 20250-0272. The manager may be contacted by phone at 
(202) 690-0621.
    We recognize that this address differs slightly from that provided 
in footnote 4 of Sec.  149.6 of the proposed rule. We have revised that 
footnote to reflect this change.
    In proposed Sec.  149.6(c)(3)(iii), we stated that, in order to 
determine the sample size for such testing, the laboratory must use the 
Trichinae Certification Slaughter Facility Sample Size Determination 
Table set forth in that paragraph to determine the number

[[Page 60470]]

of samples they must collect from the population of swine from 
certified sites. The table included in the proposed rule set sampling 
sizes for facilities that expect to process 1,000, 5,000, 25,000, 
100,000, 200,000, 400,000, 1 million, 2 million, 4 million, and 5 
million certified swine annually, respectively. We stated that the 
facility must collect the number of samples that reflects a 99 percent 
confidence level of detecting a positive carcass in a certified herd, 
based on a disease prevalence of 0.013 percent within that population, 
and stated that, if the eligible population of swine is not listed in 
the table, the facility must use the next largest number to determine 
the number of samples to collect. The number of samples selected from 
the table will be the total number of samples that slaughter facility 
representatives must collect and test per year and per month during a 
12-month period.
    A commenter pointed out that, by requiring a facility that expects 
to process a number of swine not listed on the table to obtain samples 
from the next largest population, and by providing only 10 population 
intervals, we will often require facilities to achieve a confidence 
level of more than 99 percent. If, however, we regard a 99 percent 
confidence level to be sufficient for the purposes of our program, the 
commenter proposed that we revise the table to provide population 
numbers in increments of 1,000 from 1,000 to 10,000, increments of 
2,000 from 10,000 to 25,000, increments of 5,000 from 25,000 to 
100,000, and increments of 50,000 from 100,000 to 5 million, and that 
we revise the corresponding yearly and monthly sampling sizes 
accordingly.
    We agree with this commenter, and have therefore revised the table. 
Because the revised table is large, and because the table does not 
establish operational procedures but rather clarifies procedures 
included in Sec.  149.6(c)(3)(iii) for the benefit of participating 
slaughter facilities, we have removed the table from the regulatory 
text of the final rule. It will be available on the Internet at http://www.aphis.usda.gov/vs/trichinae. We have also added a footnote to Sec.  
149.6(c)(3)(iii) stating that more information regarding sampling sizes 
may be obtained by contacting APHIS' Trichinae Program Manager.

Comment Regarding the Results of Process-Verification Testing

    In proposed Sec.  149.6(c)(4), we stated that the results of 
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 available for 
inspection by FSIS program employees.
    Proposed paragraph (c)(4)(iii) stated that, in the event of a 
positive test result, a representative of the slaughter facility must 
notify an FSIS 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. We further stated that:
    <bullet> If a test sample yields a positive test result based on 
the digestion method of detecting trichinae, then the certified 
production site that was the source of the swine from which the sample 
was taken will be decertified.
    <bullet> 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, then the certified production site that was the 
source of the swine from which the sample was taken will be 
decertified.
    <bullet> 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. This investigation may include a spot audit of 
the affected site, as well as further testing of animals or carcasses 
from the affected site. The investigation will determine if the site 
has sufficient safeguards and is following good production practices.
    One commenter understood the rule to state that a positive test 
result will result in audits of the site that was the source of the 
swine from which the sample was taken, and will cause additional 
testing to be performed on swine from that site. The commenter 
requested that APHIS provide more information regarding the nature of 
this corroborative testing in a future program standards document.
    A positive test result from a slaughter facility will result in 
subsequent testing of other animals from the site that was the source 
of the swine from which the positive sample was taken only if the 
sample yields a positive test result under the ELISA method, but does 
not do so under the digestion method. In such cases, additional testing 
is necessary to help APHIS to resolve the discrepancy between the two 
tests. We recognize, however, that we failed to specify the nature of 
this subsequent testing in the proposed rule. The testing employed will 
be the ELISA method. We will put such information in the forthcoming 
program standards document.
    In a related matter, however, we recognize that the proposed 
provisions of this paragraph could be construed to suggest that, while 
this corroborative testing is ongoing, and while the site is, 
consequently, suspended from participation in the Trichinae 
Certification Program, no swine may be sent to slaughter from the site. 
This is not the case; swine may be sent to slaughter during this time, 
but not identified as certified products from a certified production 
site. We have modified the paragraph to reflect this clarification.

Comment Regarding Recordkeeping Requirements

    In proposed Sec.  149.7(a), we set forth recordkeeping requirements 
for producers participating in the program. We stated that all sites 
would have to maintain the following program records: Animal disposal 
plan, animal movement record, feed mill quality assurance affidavit (if 
applicable), and rodent control logbook. As part of the provisions 
regarding the animal movement record, we stated that producers must 
document the number of dead non-breeding swine that are removed from 
the site, as well as the number of non-breeding swine that are buried 
or composted at the site, if swine burial or composting is permitted in 
that State or locality.
    One commenter stated that information regarding the number of non-
breeding swine that are buried or composted at the site constitutes 
confidential business information, and requested clarification 
regarding our need to retain such records.
    APHIS representatives may need to review this information in order 
to corroborate the results of an audit. It will be the site owner, not 
APHIS, who will retain the records.

Comment Regarding QAV Standards

    In proposed Sec.  161.5, we set forth requirements for 
veterinarians who wish to be recognized as qualified accredited 
veterinarians (QAVs) for the Trichinae Certification Program. We 
stipulated that, in addition to existing accreditation requirements, 
such veterinarians need to complete an APHIS-approved orientation or 
training program regarding the specializations particular to the 
certification program. Thus, an accredited veterinarian who completes 
APHIS-approved training in good production practices in swine 
management could become a QAV and be authorized to perform site audits 
within the program.

[[Page 60471]]

    One commenter, upon evaluating the existing accreditation 
requirements and our new proposed requirement, stated that it appeared 
that the only prerequisites for obtaining certification as a QAV are 
the possession of a doctorate in veterinary medicine and successful 
completion of an APHIS-approved training program. The commenter asked 
for further clarification regarding the knowledge and experience 
necessary to obtain certification as a QAV.
    QAVs must possess a Doctorate in Veterinary Medicine, must apply 
for and obtain general accreditation from APHIS under the provisions of 
9 CFR part 161, must undergo an APHIS-approved training program in good 
production practices in swine management, must adhere to the 
``Auditor's Handbook'' that we will issue upon implementation of the 
program, and must seek recertification every two years.
    In light of the commenter's question, we recognize that we did not 
provide a point of contact in our proposal for accredited veterinarians 
interested in obtaining specializations related to the Trichinae 
Certification Program. They should contact APHIS' National Trichinae 
Coordinator, or write to the Trichinae Certification Program office. We 
are adding contact information for the coordinator and the mailing 
address for the office to Sec.  149.1, as a footnote to our definition 
of qualified accredited veterinarian.

Miscellaneous Changes

    In proposed Sec.  149.2(d)(2), we stated that within 60 days of a 
change of 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. We further stated that 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.''
    In reviewing our proposal, we have determined that these provisions 
could be construed as meaning that Stage II or Stage III certified 
sites that change ownership will be precluded from obtaining Stage III 
certified status. This is not the case. While a Stage II or Stage III 
site that changes ownership and obtains a satisfactory site audit will 
continue in the program initially as a Stage II site, a new program 
anniversary date for that site will also be established based on the 
date it was audited. Thus, such sites will be able to request an audit 
in order to obtain Stage III status 240 days after the site audit 
resulting from a change of ownership, and must request one no later 
than 300 days after that audit.
    Accordingly, in this final rule, Sec.  149.2(d)(2) states more 
clearly that a Stage II or Stage III site can continue in the program 
after a change in ownership initially as a Stage II site following a 
satisfactory audit, and that 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. The producer of 
the site will then arrange for a site audit to gain (or regain) Stage 
III certified status based on that new anniversary date and according 
to the timetable prescribed in Sec.  149.3(e).
    In proposed Sec.  149.2(e)(ii), we stated that, no more than once 
every two years, a producer may request that one or more certified 
production sites be temporarily withdrawn from the program. In order to 
obtain a withdrawal, the producer would have to submit a request in 
writing to the Administrator.
    During the period of withdrawal, swine from the site would not be 
able to be identified as certified products from a certified production 
site, but the producer would still have to continue to adhere to all 
good production practices and other program requirements, unless the 
Administrator specifically waived a certain requirement in granting the 
withdrawal.
    Before being reinstated, that is, while still under temporary 
withdrawal status, the 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 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. A site found during the audit not to be adhering to one or more 
of the good production practices, including any waived during the 
period of withdrawal, would be subject to decertification.
    In reviewing our proposal, we have determined that these provisions 
appear contradictory, insofar as we require a temporarily withdrawn 
site to adhere to all the good production practices and program 
requirements, unless a requirement is explicitly waived by the 
Administrator, yet seem to allow all temporarily withdrawn sites to 
receive swine 5 weeks of age or older from noncertified sources, in 
contravention of one of the good production practices.
    We intended these provisions to allow a temporarily withdrawn site 
to receive swine from a noncertified source, only if the Administrator 
specifically waived the good production practice prohibiting such 
reception in granting the producer's request for withdrawal. Therefore, 
in this final rule, Sec.  149.2(e)(ii) now explicitly states that, in 
order to maintain status in the program, a temporarily withdrawn 
production site must obtain a waiver from the Administrator before 
receiving swine 5 weeks of age or older from a noncertified source.
    In proposed Sec.  149.4, we stated that all certified production 
sites would be subject to spot audits. Spot audits may be performed at 
random to verify the integrity of the program or, in some cases, to 
trace back and investigate a positive test result that results from the 
testing of certified swine from that site at a slaughter facility. In 
reviewing our proposal, we realize that we failed to state whether a 
spot audit of a site will affect the timetable that site was following 
for the completion of subsequent site audits, i.e., whether a new 
anniversary date will be instituted for the site based on the date that 
it undergoes the spot audit.
    Sites subjected to a spot audit will maintain the same timetable 
for completion of site audits that they had prior to the spot audit. 
The reasons for this are twofold, depending on the nature of the spot 
audit. A site that is the source of certified swine that test positive 
for trichinae under process-verification testing at a slaughter 
facility must be considered a potential source of future trichinae 
infection, even if the site passes a spot audit for cause. It is 
therefore important that the site maintain the same timetable for 
completing subsequent audits that it had prior to the spot audit, in 
order for us to adequately assess the safeguards it has in place and to 
determine the site's ongoing adherence to the program's good production 
practices.
    A random spot audit does not affect the time table for completion 
of subsequent audits because the primary aim of such an audit is not to 
assess a production site for adherence to the good production practices 
and other program standards, but to ensure the integrity of the 
auditing process itself by verifying that it is being performed in a 
consistent manner across the program.
    Therefore, paragraph (b) of Sec.  149.4 now specifies that unless a 
spot audit results in decertification, it does not otherwise affect the 
timetables for the completion of site audits set forth in this rule.

[[Page 60472]]

    In proposed Sec.  149.3(a)(5) and proposed Sec.  149.8(a)(1), we 
stated that, if a QAV performs a site audit, the producer will pay the 
QAV directly at a mutually agreed-upon time and rate. In reviewing our 
proposal, we have determined that this provision presupposes that a QAV 
will charge a producer for the cost of each site audit, and could be 
construed to specify the nature of the agreement that would occur 
between the two parties. For these reasons, we have removed this 
provision from the two paragraphs. Similarly, since a QAV may decide 
not to charge a producer for the cost of a site audit, we have removed 
statements in the same proposed paragraphs that a producer is 
responsible for the cost of the site audit.
    Finally, in a related matter, in proposed Sec.  149.3, we twice 
stated that a producer ``may'' have to contact either a QAV or QVMO in 
order to conduct a site audit. In proposed paragraph (c)(1), we stated 
that, when a producer and the producer's herd health personnel believe 
that a site meets program standards, the producer may arrange for an 
initial site audit, while, in proposed paragraph (a)(1), we stated 
that, if a QAV is not available to perform this site audit, the 
producer may then contact the APHIS area office to request that a QVMO 
perform the audit.
    In reviewing our proposal, we have determined that the use of 
``may'' in these two paragraphs could be construed as allowing a 
producer to forego an initial site audit and yet still become enrolled 
in the program. This is not the case. We have therefore replaced 
``may'' with ``must'' in these two paragraphs.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This 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.
    In accordance with the Animal Health Protection Act (7 U.S.C. 8301 
et seq.), 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 tribal 
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.
    In this rule, we are establishing regulations for a Trichinae 
Certification Program. The Trichinae Certification Program provides 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 spp., in order to facilitate 
producer access to foreign markets. The regulations also set forth 
requirements for the systematic monitoring and testing of pork products 
derived from pigs that originate from certified sites at slaughter 
facilities. Finally, we are making changes to 9 CFR parts 160 and 161 
covering the accreditation of veterinarians and veterinary medical 
officers that are needed for the Trichinae Certification Program.
    In accordance with 5 U.S.C. 604, we have prepared a Final 
Regulatory Flexibility Analysis, which is set out below, regarding the 
economic impact of this rule on small entities. The discussion also 
serves as our cost-benefit analysis under Executive Order 12866.
    Based upon available data and expected effects, we believe that the 
benefits of the final rule, in terms of increased exports, may justify 
the costs of the program for at least some of the participating 
producers and facilities. It is important to note that program 
participation will be undertaken on a strictly voluntary basis. Since 
the program is not mandatory, those producers and slaughter facilities 
that perceive costs to outweigh potential benefits will opt not to 
participate in the program.
    We first consider potential costs of the rule for participating 
producers, slaughter facilities, accredited veterinarians, and Federal 
agencies. We then examine possible benefits of the rule, in terms of 
increased export market access; we do not consider benefits in terms of 
reducing the prevalence of trichinae in the domestic herd or in 
processed pork products because the prevalence rates in both swine and 
pork products are already extremely low under the status quo. Third, we 
present alternatives to the rule. Lastly, we address expected impacts 
for small entities. In that last section, we also summarize and respond 
to significant issues raised by commenters regarding our initial 
regulatory flexibility analysis.

Costs for Participating Producers

    The number of pork producers in the United States has declined in 
recent years. According to USDA's National Agricultural Statistics 
Service (NASS), there were an estimated 76,250 hog and pig producers in 
the United States in 2002.\4\ This was down from 81,220 producers in 
2001. Since 2002, the number of producers has declined even further, 
with 65,540 operations reported in 2006. Although the structure of the 
industry has changed over time, the number of swine, as well as 
consumption of pork, has remained relatively constant over the same 
period.
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    \4\ See NASS Agricultural Statistics Data Base, http://www.nass.usda.gov/Data_and_Statistics/Quick_Stats/index.asp.
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    Participation in this program will be limited to those producers 
who house and feed swine in confinement units and who do not utilize 
waste that contains meat in their feeding regimen. Below, we refer to 
such producers as producers with currently eligible sites. The number 
of such producers who will participate in the certification program is 
not known.
    Participation by producers with currently eligible sites will 
depend primarily on economic and other market competitiveness 
considerations, that is, the expected financial and competitive 
advantages of participating, or the expected financial and competitive 
disadvantages of failing to participate. Once the program is 
implemented, producers with currently eligible sites may find that 
certain slaughter facilities will be unwilling to purchase swine from 
pork production sites that are not certified, and that producers who do 
not participate in the program will therefore face a decline in the 
marketability or value of their animals. Conversely, they may also find 
that, by participating in the program, they will be able to earn a 
premium for their swine at slaughter. Participation by producers with 
currently eligible sites, therefore, could be driven in large part by 
the decisions of slaughter facilities. However, the

[[Page 60473]]

number of slaughter facilities that will want to use the program in 
order to certify that their fresh pork and pork products destined for 
export are produced under the Trichinae Certification Program is also 
uncertain. In sum, producer participation could be driven largely by 
slaughter facility participation, and, in turn, slaughter facility 
participation could be driven by the advantages of certifying pork 
products exported to foreign markets as having been produced under the 
Trichinae Certification Program.
    Nonetheless, we believe that many producers with currently eligible 
sites, especially larger ones, are likely to participate in the 
program. This is because they have already implemented and routinely 
follow many of the good production practices required for 
certification, and will likely be able to comply with program standards 
while incurring minimal costs. Approximately 53 percent of all 
production sites are classified as total confinement.\5\ It is likely 
that close to 100 percent of commercial pork production sites housing 
swine in total confinement could meet the 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).\6\
---------------------------------------------------------------------------

    \5\ National Animal Health Monitoring System. October 2007. Part 
I: Reference of Swine Health and Management Practices in the United 
States, 2006, National Health Monitoring System. <greek-i>N475.1007. 
Fort Collins, CO.
    \6\ The definition of ``minimal'' expenditures is derived from: 
Cummings, David and Kopral, Christine, ``Cost Analysis of Trichinae-
Free Program Alternatives,'' USDA, APHIS, Centers for Epidemiology 
and Animal Health, December 1998. This document is referred to below 
as the CEAH analysis. Copies of the CEAH analysis are available by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

    In general, larger producers with currently eligible sites are more 
likely to have many of the risk mitigation measures already in place, 
and should be more readily able to participate in the program. However, 
smaller producers with currently eligible sites should also be able to 
participate in the program at relatively little cost. Since these 
smaller producers already house swine in confinement units, only 
``moderate'' facility changes (i.e., those that cost $2,500 over 5 
years) will likely be required.\7\ 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.\8\ 
Although we anticipate that most producers who decide not to 
participate in this program will be small in size, other small 
producers may need to make only minimal or moderate facility changes to 
satisfy program requirements.
---------------------------------------------------------------------------

    \7\ For more information on the nature of ``moderate'' 
expenditures, see the CEAH analysis.
    \8\ For further information, see the CEAH analysis.
---------------------------------------------------------------------------

    Producers who are currently not producing swine in confinement 
facilities may participate in the program if they convert to a 
confinement operation. According to a University of Missouri Extension 
Service study, a 200-head confinement facility costs approximately 
$42,000 to construct.\9\ This includes costs for water, feeders, site 
development, and manure storage.
---------------------------------------------------------------------------

    \9\ Available online at: http://extension.missouri.edu/explore/agguides/ansci/g02504.htm.
---------------------------------------------------------------------------

    Some of these producers may currently house and feed swine in hoop 
facilities. Such structures are roofed, but are often exposed at each 
end, and are typically not constructed in order to preclude swine from 
exposure to wildlife or rodents. Because of the nature of such 
structures, these producers may decide that it is more cost-effective 
to convert their existing facilities into confinement units than to 
build new confinement units. While no figures exist regarding the cost 
to convert an existing hoop facility to a confinement unit, a research 
project conducted by Iowa State University reported the differing 
levels of investment required for a hoop facility and a confinement 
facility.\10\ According to the study, a confinement facility costs $180 
per pig space to build versus $55 per pig space for a hoop facility.
---------------------------------------------------------------------------

    \10\ Available online at: http://www.ag.iastate.edu/farms/2001reports/rhodes/AnEconomicAnalysis.pdf.
---------------------------------------------------------------------------

    All producers seeking to participate in the program will be 
required to pay the veterinarians' audit fees for performing both 
initial and subsequent site audits, assuming the veterinarian decides 
to assess these fees. APHIS has estimated the fees to be about $150 per 
audit. After the first three audits are completed, over a 14-to 18-
month period and at a possible cost of $450, certified production sites 
will be subject to audits only once every 14 to 16 months.
    In addition to the cost of the site audit, the producer will be 
responsible for paying a separate program fee to APHIS at the time of 
each site audit. This program fee will cover APHIS' administrative 
costs in processing the audit and operating the program. The program 
fee is $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 
back to them by the slaughter facilities.
    For producers who 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 decertification. 
While a site is decertified, swine from the site may not be identified 
as product from a certified production site. In order to participate in 
the program once again, the producer will have to follow the procedures 
for requesting an initial audit for Stage I enrolled status. We expect 
that the impact of decertification on a production site will depend 
upon the extent of the affected producer's reliance on a slaughter 
facility that participates in the program and that has made a decision 
regarding purchasing swine from a decertified site that could be 
disadvantageous to the producer of that site.

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 
will depend on economic competitiveness considerations. Certain regions 
(e.g., the EU and the Russian Federation) that import pork require 
testing for trichinae. Therefore, any facility that wants to export 
pork to these regions must meet their testing requirements. Slaughter 
facilities will have to determine whether it will 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 will provide them an economic 
incentive.
    Slaughter facilities that purchase swine from certified production 
sites are required to carry out certain functions relating to 
verification, segregation, testing, and recordkeeping of certified 
swine under their control. Testing at the slaughter facility entails 
taking tissue, blood, or meat juice specimens from a sample of the 
certified swine population processed at the facility in order to 
determine the Trichinella spp. 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 will 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

[[Page 60474]]

million certified swine per year is required to run 34,802 tests 
annually, but a plant that slaughters 5,000 certified swine per year 
must run 4,996 tests each year.
    Slaughter facilities may conduct sample testing using either an 
ELISA or a pooled digestion test and have the option of processing the 
test samples themselves at the slaughter facility or sending the 
samples to an offsite commercial laboratory. Any laboratory used for 
such testing must be approved to do so by AMS, and all laboratory staff 
performing process-verification testing must be accredited by AMS to 
perform this program function. 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, will 
acquire or already have acquired ELISA test readers, regardless of 
whether they participate or intend to participate in the certification 
program, due to FSIS' hazard analysis and critical control point 
(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 about $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.\11\
---------------------------------------------------------------------------

    \11\ These figures are from the CEAH analysis. It is important 
to note that, because the CEAH study was published in 1998, the 
findings are dated. Throughout this analysis, the data used in the 
CEAH analysis have been updated wherever 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 must be confirmed by using a digestion test. For a large 
slaughter facility required to run 34,802 tests each year, the ELISA 
test will cost $28,886 annually if processed by a commercial laboratory 
and $22,969 if processed by the slaughter facility itself, and the 
digestion test will 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 
will cost $4,147 annually offsite and $3,297 annually onsite, and the 
digestion test will cost $8,593 annually offsite and $4,596 annually 
onsite.
    As discussed above, the number of slaughter facilities that will 
participate in the program by purchasing swine from certified 
production sites is uncertain. Slaughter facilities that do accept 
certified swine and identify pork as produced under the Trichinae 
Certification Program may pass on some of the testing costs to 
producers or consumers, depending on price elasticities of supply and 
demand.
    Participating slaughter facilities may experience negative effects 
from this rule in the event of a trichinae positive test. Given the 
rarity of trichinae in domestic swine currently, the likelihood of a 
positive test from an animal that comes from a certified production 
site is small. However, if there is a positive test result, the 
slaughter facility will lose the production site from which the 
infected animal originated as a source of certified swine, due to that 
site's decertification within the program. On the supply side, then, 
the cost of a positive test to the slaughter facility will depend on 
whether it has alternative sources of certified swine available. In 
addition, a positive test may bring about a decreased demand for the 
facility's products, depending on buyers' perceptions of the risks 
associated with purchasing pork products from that facility.

Costs for Participating Accredited Veterinarians

    Qualified accredited veterinarians (QAVs) will conduct the site 
audits for the certification program. We are requiring that the 
accredited veterinarian be responsible for the cost of periodic 
training to perform this activity. To become qualified, accredited 
veterinarians must complete an APHIS-approved training program in good 
production practices in swine management. At least initially, APHIS' 
National Trichinae Coordinator will provide this special training to 
accredited veterinarians, charging an amount sufficient to recover 
costs. QAVs will need requalification training, but this will not occur 
more than once every 2 years, and the accredited veterinarians will 
again be charged a fee to recover costs.
    The costs for this special training will be voluntarily incurred by 
those accredited veterinarians who decide to participate. For the 
accredited veterinarians who do opt to take the training in order to 
provide site audits for producers, it will provide a potential source 
of income in the form of fees received from participating producers for 
site audits (estimated to be about $150 per audit).

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 require various forms of food security 
certification as criteria for producers who wish to sell their products 
to them.
    With this rule, trichinae certification activities will shift in 
fiscal year (FY) 2008 from being in a pilot phase to the early national 
program rollout phase, with implementation of the program in an 
increasing number of States and involving, potentially, thousands of 
herds. The program will be made available nationwide to all who 
volunteer to participate and who meet the eligibility criteria.
    Successful implementation of the Trichinae Certification Program 
will require supporting AMS and FSIS oversight of laboratory and meat-
processing facilities. The impacts of the rule on AMS and FSIS 
operations are expected to be minimal. AMS representatives will certify 
laboratories with respect to trichinae testing, and FSIS program 
employees will check records in processing 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. Indeed, AMS has 
folded expected costs for this program into existing fee structures.

Export Benefits Associated With the Program

    The program is designed to facilitate access of domestic pork 
producers to foreign markets, and may also increase the sales and 
marketability of fresh pork products destined for those markets. It 
specifically targets those markets requiring trichinae testing for 
imported pork products, including the EU and the Russian Federation. 
Although we expect these markets to acknowledge the Trichinae 
Certification Program in lieu of the current requirements of testing 
and freezing, the decision to recognize the certification program has 
not been made to date, and there is a possibility that these regions 
will not recognize the program. However, discussions with 
representatives of the regions are ongoing.

[[Page 60475]]

    The United States is a net exporter of pork and has been the second 
largest exporter of pork, trailing the EU, in recent years. Other major 
exporters include Canada and Brazil. Japan, Mexico, and Canada are the 
primary markets for U.S. pork exports, accounting for 73 percent of 
exports. The United States also exports pork to the Russian Federation 
and the EU, but these exports averaged less than 6 percent of total 
exports from 2002 to 2005. The year 2006 was marked by an increase in 
U.S. pork exports to EU and the Russian Federation, to almost 10 
percent of total exports.
    The Trichinae Certification Program may increase opportunities for 
participating producers and slaughter facilities to export to regions 
that monitor for Trichinella spp. in pork, but this outcome is 
uncertain and the extent to which the program may lead to increased 
exports cannot be determined. U.S. pork exports have been increasing 
for the past decade, and this trend is expected to continue. On 
average, 10 percent of U.S. pork production is exported. In 2006, this 
percentage was notably higher, at 14 percent. 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 
increased export demand. The Trichinae Certification Program may 
enhance U.S. pork producers' competitiveness 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 Trichinae Certification Program will automatically 
lead directly to increased exports of pork and pork products.
    As we noted above, the Russian Federation and the EU have 
traditionally been pork markets where the United States has not had a 
large presence. It is the industry's hope that the certification 
program will open these markets more widely to U.S. pork exports. Since 
2002, Brazil has been the Russian Federation's largest supplier of 
pork. However, outbreaks of foot-and-mouth disease in the latter part 
of 2005 hampered Brazil's supply to that market. Other exporters, 
including the United States, capitalized on this opportunity to gain 
market share in the Russian pork market. In addition, in early 2007, 
the United States signed an agreement with the Russian Federation that 
allowed pork into the Russian Federation after being either tested for 
trichinae or frozen. Previously, the Russian Federation had required 
both testing and freezing. However, since this agreement was signed, 
Brazil has reentered the Russian market. With the reemergence of Brazil 
in this market, and their status as the low-cost producer, the United 
States will have difficulty holding on to any market share gained.
    The Trichinae Certification Program may lead to increased exports 
to regions that require trichinae testing, such as the EU. 
Historically, the United States has been a net importer of pork from 
the EU, with exports to the EU remaining steady from 2002 to 2006. In 
2007, Bulgaria and Romania joined the EU, and exports to the EU have 
increased dramatically since their incorporation. However, this 
increase is driven primarily by trade in lower-value pork products. The 
U.S. Meat Export Federation (USMEF) believes U.S. exports to the EU 
will increase further with the certification of new EU-approved plants 
and the reduction in costs associated with trichinae testing. The 
current 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 and they 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.
    Testing costs under the Trichinae Certification Program will 
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 regions having mandatory testing and freezing 
requirements. In fact, the average costs of testing and freezing per 
swine slaughtered are $0.02,\12\ compared to $0.15 for testing 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. 
If only a relatively small amount of pork is exported, the costs of 
testing under the program will be higher than simply testing each 
carcass destined for regions with testing and freezing requirements. 
However, if exports to these regions increase, total testing costs 
under the Trichinae Certification Program would decline and may 
eventually become lower than the costs of testing and freezing 
together, or testing or freezing alone, of every carcass destined for 
these markets. Thus, benefits in the form of reduced testing costs are 
dependent upon the level of exports.
---------------------------------------------------------------------------

    \12\ 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 will be subject to certain costs if they choose to 
participate in the Trichinae Certification Program. Producers may incur 
added expenses to ensure that their sites meet good production 
practices. Similarly, slaughter facilities that choose to receive 
certified swine for processing also may 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 and have been 
followed. Accredited veterinarians who wish to perform site audits will 
incur the cost of training necessary before performing this service for 
producers, with benefits accruing in the form of fees received from 
conducting site audits. The program itself will not impose additional 
costs on U.S. consumers, although some participating slaughter 
facilities may pass on a portion of program costs to consumers.
    As indicated in the Centers for Epidemiology and Animal Health 
(CEAH) analysis and described below, a voluntary certification program 
involving periodic testing at slaughter is less expensive than a 
program involving mandatory national testing. Also, because the program 
is voluntary, producers who judge the costs to exceed the benefits for 
their individual operation may opt not to participate in the program.

Alternatives to the Rule

    In considering alternatives to the rule, we looked to the findings 
of a CEAH analysis of alternatives to the Trichinae Certification 
Program. 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

[[Page 60476]]

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 the average 
annual cost per swine over 5 years. It is important to note that, where 
possible, we have updated the data in the CEAH study through 2002, in 
order to obtain better estimates of the cost of a voluntary 
certification program versus a mandatory program. Where recent data are 
not available, data from the 1998 study were 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.
    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 (option (a) in table 1 below) and (2) large and medium 
slaughter facilities do ELISA testing quarterly (option (b) in table 1 
below). 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 CEAH study found that the most influential variables were the 
percentage of U.S. producers that would incur no, minimal, or moderate 
costs to establish and maintain good production practices (GPP) 
sufficient for on-farm certification, and how much these costs would 
be. Three GPP scenarios appear in table 1 below. In scenario 1, most 
producers would incur no additional GPP costs; in scenario 3, 
conversely, most producers would incur moderate additional costs. 
Scenario 2 supposes a more or less even distribution among producers 
who would incur no additional costs, minimal costs, or moderate costs. 
It was necessary to consider a range of scenarios regarding the 
percentages of sites that would incur costs, because data, experiences, 
and perceptions varied significantly. Regarding the dollar amounts of 
those costs, minimal startup and maintenance costs were estimated to be 
$500 over 5 years, and moderate costs were estimated to be $2,500 over 
5 years.

   Table 1--Average Annual Cost per Swine Under On-Farm Certification
------------------------------------------------------------------------
                                                              Average
   Percentage of sites that would incur no additional       annual cost
     costs, minimal GPP costs, or moderate GPP costs      per swine over
                                                              5 years
------------------------------------------------------------------------
(a) Based on monthly ELISA testing at large/medium facilities
------------------------------------------------------------------------
Scenario 1: 90, 5, 5....................................          $0.148
Scenario 2: 36, 32, 32..................................           0.225
Scenario 3: 4, 48, 48...................................           0.271
------------------------------------------------------------------------
(b) Based on quarterly ELISA testing at large/medium facilities
------------------------------------------------------------------------
Scenario 1: 90, 5, 5....................................           0.142
Scenario 2: 36, 32, 32..................................           0.219
Scenario 3: 4, 48, 48...................................           0.265
------------------------------------------------------------------------

Mandatory Certification Program

    The alternative program, national carcass testing by the digestion 
method as described in Part II of the CEAH analysis, would entail 
testing every carcass at slaughter. Under this option, USDA would 
require swine producers to participate in a trichinae certification 
program. The CEAH analysis assumes that 95 percent of all sites would 
be certified under a mandatory program. Sites that are not certified 
would also 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 swine 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 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 would 
choose not to participate based on a cost-benefit calculation, either 
formal or informal (i.e., expected costs of participating outweigh 
expected 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) criterion, 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 would forgo benefits associated with 
the program, and any potential benefits from increased exports would 
not be realized. Producers exporting to regions that monitor for 
Trichinella spp. in pork would continue to test individual animals. The 
savings that may be realized from a voluntary certification program 
that would require testing only a sample of animals would not be 
captured.

Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to evaluate the 
potential effects of their proposed and final rules on small business, 
small organizations, and small governmental jurisdictions. Section 604 
of the Act requires agencies to prepare and make available to the 
public a final regulatory flexibility analysis (FRFA) describing any 
changes made to the rule as a result of comments received and the steps 
the agency has taken to minimize any significant economic impacts on 
small entities. Section 604(a) of the Act specifies the content of a 
FRFA. In this section, we address these FRFA requirements.

Objectives and Need for the Rule

    The objective of the rule is to facilitate producer access to 
markets that require trichinae testing, specifically the EU and the 
Russian Federation. The Trichinae Certification Program will be 
strictly voluntary.
    Due to favorable policy changes by the EU regarding the 
certification of slaughter facilities in the United States, industry 
participants anticipate that the Trichinae Certification Program may 
help domestic producers obtain a larger share of the EU market, as well 
as open that market to the exportation of chilled products. There may 
be similar effects with respect to the Russian market.

[[Page 60477]]

Summary of Significant Issues Raised by Commenters

    Comments received covered various aspects of the voluntary program. 
One commenter expressed concern with the start-up costs for producers 
wishing to participate in the program that we provided in the proposed 
rule. The commenter provided revised estimates that the commenter 
believed better represented these costs. These estimates appeared to 
suggest that recordkeeping costs would be approximately $750, and 
stated that the sterile zone that must be maintained surrounding the 
confinement unit where pigs are housed and fed, as well as the rodent 
bait stations and/or traps that this zone must contain, would cost an 
additional $1,523. In total, the commenter estimated that it would cost 
the average finishing barn $2,659.60 per site, or $2.17 per pig space, 
to come into compliance with program standards.
    APHIS finds the amounts submitted by the commenter to be high, 
particularly the approximately $750 apparently allocated for 
recordkeeping. In addition, we have determined that the costs submitted 
by the commenter for constructing such a sterile zone are also on the 
high end. In estimating the cost of a sterile zone, the commenter 
assumed that the regulation requires sterile zones to be constructed of 
crushed rock. However, we do not require the use of crushed rock for 
the sterile zone that surrounds the confinement unit. Less expensive 
level dirt or well-maintained grass may be used in lieu of crushed 
rock.
    With respect to the use of crushed rock in order to construct a 
sterile zone, we also believe that the commenter overestimated the 
costs for the construction of such a zone. As a result of 
correspondence with private companies involved in the construction and 
maintenance of sterile zones for pork production sites, we have 
estimated the costs of a sterile zone composed entirely of crushed rock 
to be between $300 and $600. While we recognize that the commenter's 
figure of $1,523 also included the cost of the rodent bait stations 
and/or traps that each sterile zone must contain, we expect that the 
cost of such rodent control measures will seldom be the bulk of costs 
associated with the construction and maintenance of a sterile zone.
    Another commenter indicated that the EU is moving to align its meat 
inspection standards more closely with FSIS regulations, which will 
motivate more U.S. plants to seek EU-approved status. If these 
regulatory changes are accomplished, additional EU-approved plants will 
likely lead to increased demand for certified swine and increased 
participation in the certification program.
    Such a scenario is possible, but has not yet occurred, and thus was 
not considered in this economic analysis.
    A commenter stated that, unless packers/exporters will be able to 
sell an entire certified carcass at a premium by participating in the 
program, rather than certain certified pork products from that carcass, 
it is unlikely that most packers/exporters will participate in the 
program. Moreover, the commenter stated that it is unlikely that most 
packers/exporters will be able to sell entire carcasses for a premium.
    Within the Trichinae Certification Program, the entire carcass of a 
certified pig and all pork products derived from that carcass are 
considered certified products, and may be identified as such. The 
ability of pork packers/exporters to sell the entire certified carcass 
for a premium will depend on the marketability of U.S. pork products 
within international markets. The program is designed to facilitate 
producer access to these overseas markets, rather than to enhance the 
marketability of pork products within these markets. The decision to 
export only certain certified pork products to overseas markets, then, 
rather than entire carcasses, will lie with the packer/exporter, and 
will depend on market forces outside the scope of this program. 
However, because of the voluntary nature of the program, those packers/
exporters who perceive the costs of program participation to outweigh 
possible benefits are free to opt not to participate.
    One commenter raised the issue of the costs of testing and freezing 
pork products under the status quo, in comparison with costs of 
process-verification testing under the Trichinae Certification Program. 
The commenter stated that testing costs under the program will be lower 
than those currently paid to test each carcass and freeze the meat from 
each carcass tested for those foreign markets that require both testing 
and freezing of imported pork products. However, the commenter pointed 
out that there are only a few markets that require both testing and 
freezing of such products. Because of this, the commenter asked whether 
our analysis had taken into account the costs of process-verification 
testing as opposed to either testing or freezing, rather than both 
testing and freezing.
    We have determined that testing costs under the voluntary program 
will initially be higher than the costs of testing or freezing alone, 
or both testing and freezing together, for those carcasses destined for 
markets requiring either or both of these trichinae-mitigation 
measures. However, the reason for this is that the United States 
currently exports a small amount of pork to regions requiring both 
testing and freezing. If pork exports to these regions increase, the 
amount of testing that takes place under the program would 
commensurately increase, economies of scale would be created, and the 
cost of testing under the certification program would become more 
economical than testing or freezing costs under the current regime. We 
anticipate that such an increase in exports may occur, although we 
recognize that any increase will be gradual and will require the EU, 
the Russian Federation, and other regions requiring testing or freezing 
to accept the certification program.
    In the preliminary analysis, we stated that domestic exporters face 
a duty free quota of 45,000 metric tons (MT) of pork to the EU, and 
that, in 2005, the United States sent approximately 6,600 MT of pork to 
the EU. We stated that the National Pork Producers Council (NPPC) had 
estimated that the implementation of the Trichinae Certification 
Program would increase exports to the EU by 16,000 MT over those 
reported in 2005. Finally, we stated that the NPPC had determined that 
an increase in this magnitude would increase the value of exports by 
$60 million.
    One commenter stated that EU pork tariff rate quotas actually 
currently allow for 74,600 MT, including 60,500 MT of pork muscle 
meats, while another commenter stated that the quota of 45,000 MT 
applies only to bone-in loins and hams. The first commenter added that 
the import quotas established by the EU directly depend on the amount 
of pork consumed within the EU, and are intended to limit pork imports 
to less than 1 percent of total annual consumption. Therefore, it 
follows that the EU quotas are not set into perpetuity at any fixed 
amount.
    In addition, one commenter stated that a 16,000 MT increase would 
actually increase the value of exports by $32 million, rather than $60 
million.
    In response to these comments, we have determined that the number 
of variables precludes us from estimating the increase in U.S. pork 
that the EU will import annually as a result of the Trichinae 
Certification Program, or the value of this increase. We have therefore 
removed such information from our analysis.

[[Page 60478]]

    Finally, two commenters submitted the following corrections and 
clarifications regarding our preliminary analysis:
    <bullet> Although, on average, approximately 9 percent of U.S. pork 
production is exported annually, this percentage rose in 2006 to more 
than 14 percent.
    <bullet> Although U.S. pork exports to the EU and the Russian 
Federation did average less than 5 percent of total exports between 
2000 and 2005, this percentage rose to almost 10 percent in 2006.
    <bullet> Whereas we stated that Brazil has historically been the 
Russian Federation's largest supplier of pork, this status in fact 
dates back only to 2002. Prior to that time, the EU was the Russian 
Federation's largest supplier.
    We have incorporated this information into our final analysis.

Description and Estimated Number of Small Entities Affected

    The final rule will have potential implications for swine producers 
and slaughter facilities both in terms of the costs they may 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 not more than 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. 
Because of the voluntary nature of the program, an estimate of the 
total number of small entities affected by this rule is not possible. 
However, APHIS personnel associated with the administration of the 
trichinae pilot programs believe that the majority of producers who 
took part in those programs were small entities.
    In addition to swine producers and slaughter facilities, accredited 
veterinarians who wish to qualify to conduct site audits will also 
incur costs associated with obtaining the specialized training 
necessary for this qualification. Establishments classified as 
providing veterinary services are likely to be small, although SBA does 
not provide the level of detail necessary to determine what percentage 
of these are, in fact, considered small. Only accredited veterinarians 
who expect to profit from obtaining such specialized accreditation are 
likely to take part in the Trichinae Certification Program.
    Participation of producers in the Trichinae Certification Program 
will also be voluntary. Small operations may decide not to participate 
in the program if they believe the costs of attaining and maintaining 
certified status outweigh the benefits of producing certified swine. As 
we noted above, these costs may include construction of a confinement 
unit (approximately $42,000), for those operations that do not 
currently house and feed swine in total confinement, or ``moderate'' 
facility changes, (i.e., those that cost $2,500 over 5 years), for 
those small producers who currently use such units. Slaughter 
facilities and accredited veterinarians will also face this decision of 
whether or not to participate. Because participation is voluntary, the 
final rule is not expected to have an adverse impact on small 
businesses operating in their own self-interest.

Description and Estimate of Compliance Requirements

    Producers are required to pay for site audits by the accredited 
veterinarian, if the veterinarian charges for this service. Producers 
are also required to pay program fees for certification by APHIS, and 
possibly testing. Producers are also required to maintain the following 
program records: Animal disposal plan, animal movement record, feed 
mill quality assurance affidavit (if applicable to the producer's 
operation), and rodent control logbook. Slaughter facilities that 
purchase swine from certified production sites will be required to 
carry out certain functions relating to verification, segregation, 
testing, and recordkeeping of certified swine under their control. 
Thus, slaughter facilities will be required to keep records of the 
number of animals slaughtered from certified sites. They will also have 
to make sure that certified and non-certified animals and products are 
kept separate throughout processing. Additionally, these facilities 
will be responsible for keeping records related to testing. In the end, 
however, it is a voluntary program, so participants will only take on 
this burden if they feel the program benefits them.

Description of Steps Taken To Minimize Significant Economic Impacts on 
Small Entities

    Since the program is voluntary, we do not expect that the final 
rule will result in significant economic impacts on small entities.

Summary

    This final rule establishes a Trichinae Certification Program. 
Producers who wish to participate may have to pay for an audit of their 
production site by a qualified accredited veterinarian. Additionally, 
they may incur at least a part of the costs of process-verification 
testing passed on by the slaughter facility conducting the test. 
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 will help domestic producers gain market share in regions that 
require trichinae testing, particularly the EU and the Russian 
Federation. The EU is revising the certification requirements for U.S. 
slaughter facilities, and industry participants anticipate that the 
voluntary certification program will substitute for the mandatory 
testing of all carcasses destined for that market. The benefits of the 
rule lie in its potential to offer a less expensive alternative to 
mandatory trichinae testing and increased access to export markets. 
However, the extent to which foreign markets will become more 
accessible is unknown.
    At present, projected costs under the certification program appear 
to be higher than current testing costs due to the relatively small 
amount of product currently exported to the EU and the Russian 
Federation. However, certain producers may find it to their advantage 
to participate, given their larger volumes of production and focus on 
foreign markets.
    The program is voluntary and does not impose any direct costs on 
small or large producers not wishing to participate. If the Trichinae 
Certification Program expands to include a large percentage of 
confinement production sites and slaughter facilities, it is possible 
that non-participating producers could experience a discount in the 
price or marketability of their swine. In the end, however, producers 
will participate in the program if they expect the benefits garnered 
from the certification program will outweigh the costs incurred.

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 final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has

[[Page 60479]]

no retroactive effect; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this final rule. The environmental assessment 
provides a basis for the conclusion that the implementation of the 
Trichinae Certification Program established by this rule will not have 
a significant impact on the quality of the human environment. Based on 
the finding of no significant impact, the Administrator of the Animal 
and Plant Health Inspection Service has determined that an 
environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were 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 of 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 impact and finding of no significant impact may 
be viewed on the Regulations.gov Web site.\13\ Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, room 1141, South Building, 
14th Street and Independence Avenue, SW., Washington, DC, between 8 
a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons 
wishing to inspect copies are requested to call ahead on (202) 690-2817 
to facilitate entry into the reading room. In addition, copies may be 
obtained by writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.
---------------------------------------------------------------------------

    \13\ Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0089. The environmental 
assessment and finding of no significant impact will appear in the 
resulting list of documents.
---------------------------------------------------------------------------

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0323.

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 rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

Lists 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.

0
Accordingly, we are amending 9 CFR chapter I as follows:

Subchapter G--Livestock Improvement

0
1. In subchapter G, the subchapter heading is revised to read as set 
forth above.

0
2. In subchapter G, a new part 149 is 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. 1622 and 8301-8317; 21 U.S.C. 136a; 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 foreign 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 Program as provided in this part.
    Certified pork. Pork products originating from certified swine from 
a

[[Page 60480]]

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.
    Confinement unit. A structure on a pork production site in which 
swine are housed and fed that is totally roofed and that is constructed 
in such a manner as to prevent swine from being exposed to free-flying 
birds and other wildlife, and from coming into contact with the carrion 
of free-flying birds or other wildlife.
    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 spp. 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 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 spp.
    Good production practices. Pork production management practices 
that reduce, eliminate, or avoid the risk of exposure of swine to 
Trichinella spp.
    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 spp. 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 confinement unit.
    Positive test result. Outcome of a validated test indicating the 
presence of Trichinella spp.
    Premises Identification Number (PIN). A number assigned to a pork 
production site by the APHIS Administrator.
    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 spp. 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 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.\2\
---------------------------------------------------------------------------

    \2\ Accredited veterinarians interested in obtaining 
specializations related to the Trichinae Certification Program 
should contact APHIS' National Trichinae Coordinator at (515) 284-
4122 or write to: USDA, APHIS, Veterinary Services, Trichinae 
Certification Program, 210 Walnut St., Room 891, Des Moines, IA 
50309.
---------------------------------------------------------------------------

    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 spp.
    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 
the confinement unit 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 spp.
    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 spp.

[[Page 60481]]

    Trichinella spp. Parasitic nematodes (roundworms) 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 spp. 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.


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 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 be subject to a review 
by APHIS to consider the nature of the infraction(s), and may 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 products 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 subject to a 
review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in paragraph 
(e)(1) of this section. During the time a site is decertified, swine 
from that site cannot be identified as certified products 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) In order to maintain Stage III certified status, sites must 
arrange for site audits to renew such status according to the timetable 
set forth in Sec.  149.3(f). Under Sec.  149.3(f), 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 status was 
last renewed.
    (5) 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 subject to a review by APHIS to consider the 
nature of the infraction(s) and determine whether to decertify the 
site, as provided in paragraph (e)(1) of this section. During the time 
a site is decertified, swine from that site cannot be identified as 
certified products 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. When a change of 
ownership occurs at a Stage II or Stage III certified site, the 
previous owner of the site must notify APHIS of this change as soon as 
the transaction is finalized. Within 60 days of this notification, 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 this notification, otherwise the 
site may be subject to decertification, in accordance with paragraph 
(e)(1) of this section. If the site audit is satisfactory, then the 
Stage II or Stage III certified site will continue in the program, 
initially as a Stage II certified site. However, 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, and the producer of the site must arrange for a site audit to 
gain (or regain) Stage III certified status based on that new 
anniversary date and according to the timetable prescribed in Sec.  
149.3(e). If the results of the site audit do not meet program 
requirements, the Stage II or Stage III site will be subject to a 
review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in paragraph 
(e)(1) of this section. 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.

[[Page 60482]]

    (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 of the good production practices as a result of 
a site 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 subject to a 
review by APHIS to consider the nature of the infraction(s) and to 
determine whether the site should be decertified. Decertification will 
result from infraction(s) that APHIS determines to be substantive, 
prolonged, and/or repeated as a result of this review.
    (ii) During the time a site is decertified, swine from such sites 
cannot be identified as certified products 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 
products 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, including documentation in the animal movement record of the 
arrival and departure of all swine from this site, as well as whether 
the swine arriving at the site are from certified or noncertified 
sources, unless a program requirement is specifically waived by the 
Administrator.
    (iv) If granted a waiver by the Administrator, a producer may 
receive swine 5 weeks of age or older originating from a noncertified 
source during the period of withdrawal.
    (v) Before being reinstated as a certified production site, the 
temporarily withdrawn site must pass a site audit to indicate that it 
is now adhering to all good production practices (including any 
practices waived by the Administrator at the beginning of the period of 
withdrawal) 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 a noncertified source have been 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 a 
noncertified source 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 now adhering to good production practices 
and other program 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, or, if 
the period of temporary withdrawal has exceeded 180 days, then the site 
will be subject to a review by APHIS to consider the nature of the 
infraction(s) and to determine whether to decertify the site, as 
provided in paragraph (e)(1) of this section. 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 or QVMO 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. If a QAV is not available to perform a 
site audit, the producer must then contact the APHIS area office to 
request that a QVMO perform the site audit. The site audit is to be 
arranged at a mutually agreed-upon time.
    (2) The producer or the producer's designated representative will 
accompany the auditor during the site audit.
    (3) During the site audit, the auditor will record whether the 
producer is adhering to all of the required good production practices 
at the site, as provided in paragraph (b) of this section, in order to 
reduce, eliminate, or avoid the risk of exposure of swine to 
Trichinella spp.
    (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) If a QVMO performs the site audit, then the producer will pay 
the QVMO at the time the site audit is performed

[[Page 60483]]

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 possible 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 substantively 
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 spp. 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 PIN 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 mill quality assurance affidavit, as provided 
in Sec.  149.7.
    (4) Swine at the site must be housed and fed in a confinement unit. 
The confinement unit, feed preparation and storage areas, and office 
areas and connecting hallways at the site must be inspected regularly 
and found free of signs of rodent and wildlife activity (evidence of 
rodent activity 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). 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., 
equipment) must be checked for signs of rodent or wildlife activity. In 
addition, domesticated animals, including pets such as dogs and cats, 
must be excluded from the confinement unit and feed preparation and 
storage areas at the site. Exterior rodent bait stations and/or traps 
must be placed around the perimeter of the confinement unit. Exterior 
rodent bait stations and/or traps also must be placed around areas of 
potential rodent entry into the confinement unit (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 the confinement unit. 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., equipment, 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 as 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

[[Page 60484]]

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 dead or live wildlife at the 
site. Dead or live wildlife must not be intentionally fed to swine.
    (7) Swine at the site must not be fed waste that contains meat.
    (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 must 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 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 be subject to 
a review by APHIS to consider the nature of the infraction(s), and may 
lose its status as a Stage I 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 
a review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in Sec.  
149.2(e)(1).
    (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 the that 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 as a 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 
a review by APHIS to consider the nature of the infraction(s) and 
determine whether to decertify the site, as provided in Sec.  
149.2(e)(1).

(Approved by the Office of Management and Budget under control 
number 0579-0323)


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

[[Page 60485]]

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 a review by APHIS to consider the nature of the infraction 
and to determine whether to decertify the site, as provided in Sec.  
149.2(e)(1). Unless a spot audit results in decertification, it does 
not otherwise affect the timetables for the completion of site audits 
set forth in paragraphs (e) and (f) of Sec.  149.3.


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 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 to determine the Trichinella spp. infection status of certified 
swine under its control as follows:
    (1) Validated tests. Process-verification testing must be performed 
by using a validated test. When testing involves meat, the sample used 
for such testing must be at least 20 grams.\4\
---------------------------------------------------------------------------

    \4\ A copy of the testing methods and checklist for conducting 
validated tests may be obtained by contacting the AMS Trichinae 
Analyst and Laboratory Certification Program Manager, USDA, AMS, 
Science and Technology Programs, Technical Services Branch, 1400 
Independence Ave., SW., Mail Stop 0272, Washington, DC 20250-0272. 
The manager may be contacted by phone 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 AMS Trichinae Analyst 
and Laboratory Certification Program Manager (see footnote 4).
---------------------------------------------------------------------------

    (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 on the 
Internet at http://www.aphis.usda.gov/vs/trichinae to find the number 
of samples to collect from the population of swine from certified 
production sites.\6\ If the eligible population is not listed in that 
table, 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 on that table that reflects a 99 percent confidence level of 
detecting a positive carcass in a population with a prevalence rate of 
0.013 percent. The number selected from the table 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.
---------------------------------------------------------------------------

    \6\ More information regarding sampling sizes may be obtained by 
writing to USDA, APHIS, Veterinary Services, Trichinae Certification 
Program, 210 Walnut St., Room 891, Des Moines, IA 50309.
---------------------------------------------------------------------------

    (iv) For each sample collected, slaughter facility representatives 
must maintain the identity of the sample using the PIN 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.

[[Page 60486]]

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.
    (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 PIN 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. During this suspension, swine at 
the site may be sent to slaughter; 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 PIN 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), 
and rodent control logbook. 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.

[[Page 60487]]

    (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 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 
PIN 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 PIN 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 information 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.
    (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.

(Approved by the Office of Management and Budget under control 
number 0579-0323)

Sec.  149.8  Program fees and charges.

    (a) Site audit. 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 1 for each employee required to 
perform the service. If the APHIS-employed QVMO performs the site audit 
on a Sunday, on 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 2 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 1--Rates for Services of QVMO
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Hourly rate:
    Per hour.................................................     $84.00
    Per quarter hour.........................................      21.00
Per service minimum fee......................................      25.00
------------------------------------------------------------------------


  Table 2--Overtime Rates for Services of QVMO (Outside the Employee's
                          Normal Tour of Duty)
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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
------------------------------------------------------------------------


[[Page 60488]]

    (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 November 10, 2008 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

0
3. The authority citation for part 160 continues 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.


0
4. In Sec.  160.1, a new definition is 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 acccreditation 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

0
5. The authority citation for part 161 continues 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.

0
6. Section 161.5 is 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.

    Done in Washington, DC, this 2nd day of October 2008.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E8-23678 Filed 10-8-08; 11:15 am]
BILLING CODE 3410-34-P