60464 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2006-0089. 

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. 

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. 

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 processverification 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.’’ 


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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 meatcontaining 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 byproducts 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 § 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 § 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 § 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 § 149.1, the proposed definition 

waste feeding logbook has been 

removed. Such a logbook is no longer 

necessary. 

• In § 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 § 149.7, the introductory text of 

paragraph (a) no longer refers to a 

‘‘waste feeding logbook.’’ In the same 

section, we have removed paragraph 

(a)(5), which would have established 

requirements for a waste feeding 

logbook. 

Two commenters stated that, while 

the proposed rule stipulates that 

slaughter facility representatives must 

collect and test enough samples of 

swine from a certified production site to 

achieve a 99 percent confidence level of 


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detecting trichinae if it exists in a 

certified herd based on a prevalence of 

0.013 percent, the EU’s trichinae 

regulations require testing sufficient to 

achieve a 95 percent confidence level in 

a sample population. One of these 

commenters stated that a 99 percent 

confidence level is therefore 

unnecessary, and that the confidence 

level ought to be lowered to 95 percent. 

The provisions of this program align 

with EU standards to the greatest extent 

possible. However, because the program 

is voluntary, we expect both the number 

of swine that could be tested under 

process-verification testing, and, 

accordingly, the number that actually 

will be tested to differ from those of the 

EU. Thus, adhering to a 99 percent 

confidence level provides an additional 

degree of assurance to our trading 

partners that the standards of the 

Trichinae Certification Program are 

sufficiently rigorous, and does not 

impose a significantly greater amount of 

process verification testing on a 

participating slaughter facility than the 

adoption of a 95 percent confidence 

level would. If we were to adopt a 95 

percent confidence level, a facility that 

slaughters 5,000 certified swine 

annually would have to conduct testing 

on 9 fewer samples yearly than it would 

in order to achieve a 99 percent 

confidence level, and a facility that 

slaughters 1 million certified swine 

annually would have to test 5,291 fewer 

samples yearly. In addition, we have 

determined that process-verification 

testing under the provisions of the 

Trichinae Certification Program will 

cost, at most, approximately $1.72 per 

swine. Thus, the adoption of a 95 

percent confidence level, as opposed to 

a 99 percent confidence level, would 

not result in a large difference in the 

annual cost of process-verification 

testing for a slaughter facility that 

participates in the program, relative to 

the total annual cost of processverification 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 processverification 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 § 149.6, paragraph 

(c)(1) now reads as follows: ‘‘Processverification 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 § 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 § 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 § 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 processverification testing at a participating 

slaughter facility, and a certificate of 

export identifying the products as being 

from the Trichinae Certification 

Program may not be issued. 


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One commenter suggested that the 

$51 program fee for producers seeking 

Stage I status is insufficient, and will 

ultimately force APHIS to request a 

larger budget allocation in order to 

offset the losses generated by the 

program. Conversely, another 

commenter pointed out that producers 

who took part in the pilot programs 

assumed all costs for obtaining and 

maintaining compliance with program 

standards, and would likely be 

unwilling to pay program fees following 

implementation of this rule. The 

commenter stated that, instead of 

imposing a program fee, APHIS should 

operate the program out of federally 

appropriated funds. 

In the proposed rule, we itemized and 

evaluated the pro rata costs associated 

with the pilot program. These costs 

included those incurred in providing 

direct and support labor for the pilot 

program, estimated agency overhead, 

and departmental charges. We then 

divided this number by the total number 

of applications that had been processed 

within the pilot program at the time and 

determined that a $51 program fee, 

assessed each time a site audit is 

performed within the Trichinae 

Certification Program, would be 

sufficient to cover our administrative 

costs in processing the audit and 

operating the program. 

However, we do recognize that this 

fee represents our best estimation of the 

probable costs associated with 

processing audit forms and 

administering the program at the time 

our evaluation took place, fiscal year 

(FY) 2005. Therefore, we have reviewed 

the fee to determine whether it needs to 

be adjusted for FY 2008 and FY 2009. 

As a result of this review, and using the 

same methodology to arrive at the fee as 

we did in the proposed rule, we have 

determined that a program fee of $ 51 

should cover costs associated with the 

program in both fiscal years. 

We note, moreover, that APHIS 

regularly reviews all fees that we assess 

for our programs and, if necessary, 

undertakes rulemaking to amend them. 

In accord with this practice, we intend 

to review the program fee yearly based 

on the date of the initial implementation 

of the program, beginning in FY 2010, 

and will initiate rulemaking each time 

we need to change it. 

Another commenter stated that, by 

not allowing producers with Stage I 

enrolled status to identify their swine as 

certified products or identify their 

facility as a certified production site, we 

are limiting the program’s ability to 

immediately facilitate the exportation of 

fresh pork and pork products to 

overseas markets. In the commenter’s 

estimation, if the program is 

operational, but pork products shipped 

overseas lack identifiable certification of 

freedom from trichinae, it may take 

foreign markets several years to formally 

acknowledge the program. To expedite 

access to those markets, the commenter 

suggested that the first sites awarded 

Stage I status should be considered 

certified and allowed to immediately 

begin process-verification testing at 

participating slaughter facilities. 

Section 149.9 of this final rule states 

that those sites that have been 

participating in an APHIS-approved 

trichinae pilot program at the time of 

implementation of the Trichinae 

Certification Program will maintain 

their same program status as Stage I, 

Stage II, or Stage III certified sites. Thus, 

pork production sites that obtained 

certified status within a pilot program 

will be allowed to immediately identify 

their swine as certified products from a 

certified production site within the 

program. This provision addresses the 

commenter’s concern. 

In addition, we regard the provisions 

of the rule precluding Stage I enrolled 

sites from immediately identifying their 

products as certified and engaging in 

process-verification testing to be 

necessary for us to determine whether 

such sites are able to adhere to the good 

production practices, recordkeeping, 

and program requirements specified by 

this rule over a sufficient period of time 

before obtaining certification. Removing 

these provisions could impede our 

ability to adequately assess such 

adherence, and thus adversely affect the 

integrity of the program. Specifically, 

before a site audit takes place for Stage 

I status within the program, APHIS has 

no assurance that the site has been 

adhering to the good production 

practices of the Trichinae Certification 

Program up to the point of the audit, 

and must take into consideration the 

possibility that swine at the site were 

produced at one point of their lives 

under standards at variance with 

program standards. Under the 

provisions of the program, any such 

swine would be sent to slaughter in 

most circumstances before the site was 

eligible for Stage II certified status. 

Comments Regarding a Change in 

Ownership of a Certified Production Site 

In § 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 § 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 § 149.2(e)(1). We have amended 

§ 149.2(d)(2) to reflect this clarification. 

Comments Regarding Site 

Decertification and Renewal 

In proposed § 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 


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2The Business Plan is available on the Internet 

at http://animalid.aphis.usda.gov/nais/. 

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 

§ 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 §§ 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 § 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 § 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. 

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 § 149.3 described measures to 

be taken to prevent infestations by 


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3To view this document, go to http:// 

www.epa.gov/pesticides/reregistration/ 

rodenticides/rodenticides_mitigation_decision.pdf. 

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. 

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 § 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 § 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 ProcessVerification Testing 

In proposed § 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 § 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 § 149.6 of the proposed rule. We 

have revised that footnote to reflect this 

change. 

In proposed § 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 


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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 § 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 

§ 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 § 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 § 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 § 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. 


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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 APHISapproved 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 APHISapproved 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 § 149.1, as a footnote to 

our definition of qualified accredited 

veterinarian. 

Miscellaneous Changes 

In proposed § 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, 

§ 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 § 149.3(e). 

In proposed § 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, 

§ 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 § 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 processverification 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 § 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. 


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4See NASS Agricultural Statistics Data Base, 

http://www.nass.usda.gov/Data_and_Statistics/ 

Quick_Stats/index.asp. 

In proposed § 149.3(a)(5) and 

proposed § 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 § 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 costbenefit 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. 

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 


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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 60473 

5National 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. 

6The 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. 

7For more information on the nature of 

‘‘moderate’’ expenditures, see the CEAH analysis. 

8For further information, see the CEAH analysis. 

9Available online at: http:// 

extension.missouri.edu/explore/agguides/ansci/ 

g02504.htm. 

10Available online at: http://www.ag.iastate.edu/ 

farms/2001reports/rhodes/ 

AnEconomicAnalysis.pdf. 

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

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. 

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. 

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. 

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 


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60474 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

11These 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. 

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

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 meatprocessing 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. 


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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 60475 

12Testing 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. 

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-andmouth 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 EUapproved 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 EUapproved 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. 

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 


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60476 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

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 onfarm 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 onfarm 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

Percentage of sites that 

would incur no additional 

costs, minimal GPP costs, or 

moderate GPP costs 

Average 

annual cost 

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. 


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


pwalker on PROD1PC71 with RULES3
60478 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

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 noncertified 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 


pwalker on PROD1PC71 with RULES3
Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 60479 

13 Go to http://www.regulations.gov/fdmspublic/ 

component/main?main=DocketDetail&d=APHIS2006-0089. The environmental assessment and 

finding of no significant impact will appear in the 

resulting list of documents. 

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. 

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. 

■ Accordingly, we are amending 9 CFR 

chapter I as follows: 

Subchapter G—Livestock Improvement 

■ 1. In subchapter G, the subchapter 

heading is revised to read as set forth 

above. 

■ 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. 

§ 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. 

§ 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 


pwalker on PROD1PC71 with RULES3
60480 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

1The 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. 

2Accredited 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. 

certified production site with identity of 

such animals or carcasses maintained 

throughout receiving, handling, and 

processing.1

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 § 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

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. 


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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. 

§ 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 

§ 149.3(d). Under § 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 

§ 149.3(e). Under § 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 § 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 

§ 149.3(f). Under § 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 § 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. 


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(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. 

§ 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 APHISapproved 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 


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in accordance with the rate and other 

conditions set by the QVMO’s 

governmental employer. If an APHISemployed 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 § 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 

§ 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 APHISemployed 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 § 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 § 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-today 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 § 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-today 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 


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3The 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. 

the walls to allow for inspection, 

baiting, and/or trapping. The rodent 

control logbook, as provided in § 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 

§ 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 

§ 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. 

(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 § 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 § 149.2(e)(1). 

(Approved by the Office of Management and 

Budget under control number 0579–0323) 

§ 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 


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4A 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. 

5A 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). 

6More 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. 

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 § 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 § 149.3. 

§ 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. 

§ 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. Processverification 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

(2) Laboratory approval. Processverification 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 processverification 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. 

(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. 

(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. 


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FSIS will report this information to 

APHIS. 

(vi) AMS representatives will verify 

through a laboratory approval audit that 

the laboratory performing processverification 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 processverification 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 processverification 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. 

§ 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. 


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

§ 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 


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(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. 

§ 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 

■ 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. 

■ 4. In § 160.1, a new definition is 

added, in alphabetical order, for 

qualified accredited veterinarian (QAV) 

to read as follows: 

§ 160.1 Definitions. 

* * * * * 

Qualified accredited veterinarian 

(QAV). An accredited veterinarian who 

has been granted an acccreditation 

specialization by the Administrator 

pursuant to § 161.5 of this subchapter 

based on completion of an APHISapproved orientation or training 

program. 

* * * * * 

PART 161—REQUIREMENTS AND 

STANDARDS FOR ACCREDITED 

VETERINARIANS AND SUSPENSION 

OR REVOCATION OF SUCH 

ACCREDITATION 

■ 5. The authority citation for part 161 

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. 

■ 6. Section 161.5 is added to read as 

follows: 

§ 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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