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[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Rules and Regulations]
[Page 60463-60488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc08-13]
[[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
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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:
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
[[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.
[[Page 60467]]
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.
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\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.
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\3\ To view this document, go to http://www.epa.gov/pesticides/
reregistration/rodenticides/rodenticides_mitigation_decision.pdf.
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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:
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 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\
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\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. 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.
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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/). 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:
Although, on average, approximately 9 percent of U.S. pork
production is exported annually, this percentage rose in 2006 to more
than 14 percent.
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.
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.
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\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.
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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\
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\1\ The labeling of all certified pork or pork products leaving
a slaughter or processing facility must comply with 9 CFR 317.4 and
all other applicable FSIS labeling regulations.
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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\
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\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.
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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
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/ 2008
/ October
/ Friday, October 10, 2008
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