Trichinae Certification Program, 60464-60488 [E8-23678]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Rules and Regulations]
[Pages 60464-60488]
From the Federal Register Online via the Government Printing 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

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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 https://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:
     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.
     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.
     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.''
     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:
     In Sec.  149.1, the proposed definition waste feeding 
logbook has been removed. Such a logbook is no longer necessary.
     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.''
     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

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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 https://
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 https://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 https://
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:
     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.
     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.
     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 livesto