We have determined that proposed provisions that would have allowed swine to be fed meatcontaining 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:

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 processverification 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 Sec. 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 Sec. 149.0, ``Purpose and scope,'' we state that the purpose of the Trichinae Certification Program is to enhance the ability of domestic swine producers, as well as slaughter facilities and other persons that handle or process swine from pork production sites that have been certified under the program, to export fresh pork and pork products to foreign markets.

One commenter suggested that we should widen the scope of the program to include the possible use of the program for domestic marketing purposes. Conversely, another commenter expressed concern that the program could result in domestic products being labeled for certification of freedom from trichinae or for compliance with program standards, and suggested that such marketing could have an adverse effect on producers who do not participate in the program.

Although we recognize that producers may wish to participate in the program for domestic marketing purposes, such uses are currently outside the scope of our proposed provisions, as we noted by including a statement about the limited scope and purpose of the program in the regulations. We acknowledge that the Administrator of APHIS has authority under the AMA with respect to voluntary inspection and certification of animal products and the inspection, testing, treatment, and certification of animals. At this time, however, the intent of our rule is to establish a program that will enhance the ability of domestic swine producers, as well as slaughter facilities and other persons that handle or process swine from pork production sites that have been certified under the program, to export fresh pork and pork products to foreign markets. Any amendments to the scope of the program to include a domestic marketing aspect would be undertaken in a separate rulemaking.

We recognize, moreover, that we referred to the labeling of pork products once in the regulatory text of the proposed rule. In our proposed definition of certified pork, footnote 1 stated that the labeling of all pork products leaving a slaughter or processing facility must comply with 9 CFR 317.4 and all other applicable FSIS labeling regulations.

However, we did not intend the footnote as an endorsement of the labeling of pork products destined for domestic or international markets as certified under the Trichinae Certification Program. Rather, we wished to emphasize that the labeling of pork products, whether conducted in conjunction with the Trichinae Certification Program or otherwise, falls under the purview of FSIS, rather than APHIS, and must comply with FSIS regulations. Recognition of such a label as an official label would need to occur through a separate regulatory action.

Comments Regarding Stage I Status

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

Section 149.9 of this final rule states that those sites that have been participating in an APHISapproved 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 processverification testing to be necessary for us to determine whether such sites are able to adhere to the good production practices, recordkeeping, and program requirements specified by this rule over a sufficient period of time before obtaining certification. Removing these provisions could impede our ability to adequately assess such adherence, and thus adversely affect the integrity of the program. Specifically, before a site audit takes place for Stage I status within the program, APHIS has no assurance that the site has been adhering to the good production practices of the Trichinae Certification Program up to the point of the audit, and must take into consideration the possibility that swine at the site were produced at one point of their lives under standards at variance with program standards. Under the provisions of the program, any such swine would be sent to slaughter in most circumstances before the site was eligible for Stage II certified status.
Comments Regarding a Change in Ownership of a Certified Production Site

In Sec. 149.2(d) of the proposed rule, we described a protocol for producers to follow in the event that there is a change of ownership in a site participating in the program. If there is a change in ownership to a Stage I enrolled site, the site will continue to operate on the same timetable as under the previous ownership for completing a site audit for Stage II certified status. If there is a change in ownership at a Stage II or Stage III certified site, a site audit must be performed on that site within 60 days of the change of ownership. If the site audit is satisfactory, the site will continue in the program only as a Stage II certified site. A Stage III site that has reverted to a Stage II site because of a change of ownership will be subject to another site audit within 10 months' time; if that audit is satisfactory, we will issue the site a new program anniversary date as a starting date for the purposes of performing future audits. If the results of any site audit arising from a change of ownership are not satisfactory, we may decertify the site, and the site will have to reapply for Stage I enrolled status.

One commenter pointed out that these provisions appear to apply only to a change of ownership of a participating production site. The commenter asked whether a change in ownership of a herd at a production site, without a change in ownership of the site itself, would be subject to a similar protocol.

The provisions are intended to apply to site ownership, not herd ownership. If the ownership of the certified site remains the same, and site audits continue to confirm the facility's adherence to the good production practices stipulated by this rule, the ownership of the swine at the facility may change without triggering the need for the additional audits and other measures described in Sec. 149.2(d).

The same commenter asked which party assumes responsibility for notifying APHIS of this change in ownership of the facility.

The outgoing owner of the facility will notify APHIS of the change in ownership. Once such notification has occurred, the new owner will arrange for a site audit, provided that this new owner wishes to remain within the Trichinae Certification Program. Without such an audit, the site may be subject to decertification, in accordance with Sec. 149.2(e)(1). We have amended Sec. 149.2(d)(2) to reflect this clarification.

Comments Regarding Site Decertification and Renewal

In proposed Sec. 149.2(e)(1), we stated that a Stage II or Stage III certified site that is found not to be adhering to one or more good production practices as a result of a site audit or spot audit, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment to continue participation in the program, will be decertified by APHIS. During the time a site is decertified, swine from that site cannot
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be identified as certified product from a certified production site. Once a site is decertified by APHIS, a producer wishing to participate in the program again must follow the procedures for requesting a site audit for Stage I enrolled status.

One commenter stated that late payment or an incomplete audit form should not result in decertification of a production site. Instead, the commenter suggested that we should work with producers to address these errors before assessing a penalty, since such errors will usually be clerical in nature.

The same commenter agreed that violations of the good production practices should provide a basis for decertification in certain instances, but stated that we should make a distinction between substantive violations and minor infractions. The commenter suggested that we could differentiate between violations based on whether they can easily be rectified.

We believe decertification would be an appropriate response to substantive violations of good production practices as well as prolonged or repeated failures to observe the program's recordkeeping requirements or timetable for submitting forms and payment.

However, we do recognize that there will be instances of violations that are minor, inadvertent, and easily rectified, and that violations of that nature should not necessarily lead to decertification in all cases. Therefore, we have amended Sec. 149.2(e)(1) to read as follows: ``A Stage II or Stage III certified site that is found not to be adhering to one or more of the good production practices as a result of a site audit, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment to continue participation in the program, will be subject to a review by APHIS to consider the nature of the infraction(s) and to determine whether the site should be decertified. Decertification will result from infraction(s) that APHIS determines to be substantive, prolonged, and/or repeated as a result of this review.''

To reflect this change, we have also amended Sec. Sec. 149.2, 149.3, and 149.4 to provide that APHIS will conduct a review to consider the nature of possible infractions of the good production practices or administrative requirements associated with the program before decertifying a production site.

We are, however, retaining the provisions in the proposed rule that stated that if a test sample obtained at a slaughter facility from a certified swine yields positive test results based on the pooled digestion method of detecting trichinae, or based on the ELISA method as corroborated by the digestion method, we would decertify the production site that was the source of the swine from which the sample was taken.

Comments Regarding Procedures for a Request for Review

In proposed Sec. 149.2(f), we stated that, if there is a conflict as to any material fact relating to the results of a site audit, spot audit, or other determination affecting the producer's program status or ability to participate in the program, the producer may submit a written request for review to the Administrator. The producer must include in the request the reasons, including any supporting documentation, why the audit result or other determination should be different than the result or determination made by the Administrator. The initial audit result or other determination will remain in force pending the completion of the Administrator's review. The decision by the Administrator upon reviewing the producer's written request will be final.

One commenter pointed out that, under the terms of the proposed rule, APHIS is responsible both for decertifying a site and for evaluating the request for review. The commenter stated that this may present or give the appearance of presenting a conflict of interest, and asked that we amend the rule to have another party evaluate each request for review.

We are making no change in response to this comment. The review process contained in the rule is intended not as a judicial process, but as an opportunity for producers to present information to the Administrator that may help to determine whether the initial decision was in error. Therefore, it is reasonable that APHIS should be responsible both for decertification and review of our determination.

We have used such a process within other certification and approval programs that we administer, and have found it to provide an effective means of review.

Comments Regarding Good Production Practices

In Sec. 149.3(b) of the proposed rule, we set forth good production practices that producers must adhere to in order to participate in the program.

Proposed paragraph (b)(2) stated that all nonbreeding 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, industryadministered 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 APHISadministered disease programs by using the PIN as the unique location identifier for these programs. Accordingly, each producer who enrolls in the Trichinae Certification Program will be issued a PIN. We have amended the regulatory text in this final rule to reflect this change.
\2\ The Business Plan is available on the Internet at http:// animalid.aphis.usda.gov/nais/.

In addition, while the data entry fields in the NPIR are not configured in a way that would allow the association requested by the commenter, we are exploring whether other databases maintained by APHIS' National Center for Animal Health Programs can recognize a producer's certified status within the program and associate it with other data elements. We will provide notice in a future iteration of the program standards if such recognition and association become possible.

Paragraphs (b)(4) and (b)(5) of proposed Sec. 149.3 described measures to be taken to prevent infestations by
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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 EPAregistered 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 19921993; Docket No. EPAHQOPP 20060955; FRLE1047) that announced the availability of a proposed mitigation decision restricting the use of several rodenticides currently on the market. The commenter asked us to evaluate both the possible increased cost and decreased efficacy of rodenticides as a result of this decision.

On May 28, 2008, EPA released its final decision, titled ``Risk Mitigation Decision for Ten Rodenticides.'' \3\ In it, EPA decided not to restrict the use or otherwise alter the efficacy of these rodenticides, but instead decided upon sale and distribution limitations on the products to limit their use in residential settings. EPA's final decision contained an evaluation of the potential economic impacts of these limitations for poultry and livestock producers, and determined that these limitations would not change the availability of the rodenticides for such producers.
\3\ To view this document, go to http://www.epa.gov/pesticides/ reregistration/rodenticides/rodenticides_mitigation_decision.pdf.

Finally, one commenter asked us to consider the use of bird proofing shields as an additional good production practice. The commenter suggested that the use of such barriers would prevent pigs from exposure to carrion, would add another safeguard to promote rodent control, and would further prevent swine's contact with wildlife.

As noted previously, this final rule provides that only pork production sites that house and feed pigs in confinement units may participate in the Trichinae Certification Program. All confinement units are constructed so as to prevent the exposure of swine to free flying birds, wildlife, and carrion.

Comments Regarding Renewal of Stage III Certified Status

In Sec. 149.2(c) of the proposed rule, we stipulated that sites that achieve Stage III certified status will be subject to subsequent site audits to determine continued participation in the program. In Sec. 149.3(f), we stated that such site audits must be performed no sooner than 14 months, and no later than 16 months, from either the date the site was awarded Stage III status or the date of the last renewal. If, as a result of any of these renewal audits, we determine that the site is not adhering to one or more of the good production practices, the site will be subject to decertification.

We received two comments regarding these paragraphs. The commenters agreed that the first few renewals should occur at intervals of 14 to 16 months, but stated that subsequent audits for recertification should occur less frequently. One of the commenters stated that the change in frequency should occur after 5 years of successful recertification audits, and that the intervals should increase at that point to no less than 28 months and no more than 32 months. The other commenter suggested that the change should occur after the second successful renewal, and that all subsequent audits should be conducted at a maximum of 30month 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 16month 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 Sec. 149.6(c), we stated that slaughter facilities processing certified swine are responsible for performing process verification testing at their expense in order to determine the Trichinella spp. infection status of certified swine under their control. In proposed Sec. 149.6(c)(2), we stated that all testing must be performed in a laboratory that has been approved for trichinae testing by AMS. We further stated that the laboratory may be maintained and operated by the slaughter facility or by another business entity, and may be at the slaughter facility or offsite, but that, regardless of its location, the laboratory staff performing the tests must be approved by AMS, and will be subject to periodic proficiency test panels from AMS that will have to be analyzed correctly in order to maintain approved status.

One commenter asked for clarification regarding the process AMS employs to approve a laboratory, the cost of this initial approval and any subsequent audits/recertification, the possibility of combining such audits and recertification with other programs administered by AMS, the causes of decertification or withdrawal of approval of a laboratory or its personnel, the procedure for recertification, and the ramifications for deviations from standard operating procedures for the laboratory.

Slaughter facilities and other business entities interested in more information regarding the AMS approval process for processverification 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 202500272. The manager may be contacted by phone at (202) 6900621.

We recognize that this address differs slightly from that provided in footnote 4 of Sec. 149.6 of the proposed rule. We have revised that footnote to reflect this change.

In proposed Sec. 149.6(c)(3)(iii), we stated that, in order to determine the sample size for such testing, the laboratory must use the Trichinae Certification Slaughter Facility Sample Size Determination Table set forth in that paragraph to determine the number
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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 12month period.

A commenter pointed out that, by requiring a facility that expects to process a number of swine not listed on the table to obtain samples from the next largest population, and by providing only 10 population intervals, we will often require facilities to achieve a confidence level of more than 99 percent. If, however, we regard a 99 percent confidence level to be sufficient for the purposes of our program, the commenter proposed that we revise the table to provide population numbers in increments of 1,000 from 1,000 to 10,000, increments of 2,000 from 10,000 to 25,000, increments of 5,000 from 25,000 to 100,000, and increments of 50,000 from 100,000 to 5 million, and that we revise the corresponding yearly and monthly sampling sizes accordingly.

We agree with this commenter, and have therefore revised the table. Because the revised table is large, and because the table does not establish operational procedures but rather clarifies procedures included in Sec. 149.6(c)(3)(iii) for the benefit of participating slaughter facilities, we have removed the table from the regulatory text of the final rule. It will be available on the Internet at http:// www.aphis.usda.gov/vs/trichinae. We have also added a footnote to Sec. 149.6(c)(3)(iii) stating that more information regarding sampling sizes may be obtained by contacting APHIS' Trichinae Program Manager. Comment Regarding the Results of ProcessVerification Testing

In proposed Sec. 149.6(c)(4), we stated that the results of 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 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:

One commenter understood the rule to state that a positive test result will result in audits of the site that was the source of the swine from which the sample was taken, and will cause additional testing to be performed on swine from that site. The commenter requested that APHIS provide more information regarding the nature of this corroborative testing in a future program standards document.

A positive test result from a slaughter facility will result in subsequent testing of other animals from the site that was the source of the swine from which the positive sample was taken only if the sample yields a positive test result under the ELISA method, but does not do so under the digestion method. In such cases, additional testing is necessary to help APHIS to resolve the discrepancy between the two tests. We recognize, however, that we failed to specify the nature of this subsequent testing in the proposed rule. The testing employed will be the ELISA method. We will put such information in the forthcoming program standards document.

In a related matter, however, we recognize that the proposed provisions of this paragraph could be construed to suggest that, while this corroborative testing is ongoing, and while the site is, consequently, suspended from participation in the Trichinae Certification Program, no swine may be sent to slaughter from the site. This is not the case; swine may be sent to slaughter during this time, but not identified as certified products from a certified production site. We have modified the paragraph to reflect this clarification. Comment Regarding Recordkeeping Requirements

In proposed Sec. 149.7(a), we set forth recordkeeping requirements for producers participating in the program. We stated that all sites would have to maintain the following program records: Animal disposal plan, animal movement record, feed mill quality assurance affidavit (if applicable), and rodent control logbook. As part of the provisions regarding the animal movement record, we stated that producers must document the number of dead nonbreeding swine that are removed from the site, as well as the number of nonbreeding swine that are buried or composted at the site, if swine burial or composting is permitted in that State or locality.

One commenter stated that information regarding the number of non breeding swine that are buried or composted at the site constitutes confidential business information, and requested clarification regarding our need to retain such records.

APHIS representatives may need to review this information in order to corroborate the results of an audit. It will be the site owner, not APHIS, who will retain the records.

Comment Regarding QAV Standards

In proposed Sec. 161.5, we set forth requirements for veterinarians who wish to be recognized as qualified accredited veterinarians (QAVs) for the Trichinae Certification Program. We stipulated that, in addition to existing accreditation requirements, such veterinarians need to complete an APHISapproved orientation or training program regarding the specializations particular to the certification program. Thus, an accredited veterinarian who completes APHISapproved 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 Sec. 149.1, as a footnote to our definition of qualified accredited veterinarian.

Miscellaneous Changes

In proposed Sec. 149.2(d)(2), we stated that within 60 days of a change of ownership of a Stage II or Stage III certified site, a site audit must be performed in order for the site to maintain its certified status. We further stated that if the site audit is satisfactory, then the Stage II or Stage III certified site will continue in the program ``only as a Stage II certified site.''

In reviewing our proposal, we have determined that these provisions could be construed as meaning that Stage II or Stage III certified sites that change ownership will be precluded from obtaining Stage III certified status. This is not the case. While a Stage II or Stage III site that changes ownership and obtains a satisfactory site audit will continue in the program initially as a Stage II site, a new program anniversary date for that site will also be established based on the date it was audited. Thus, such sites will be able to request an audit in order to obtain Stage III status 240 days after the site audit resulting from a change of ownership, and must request one no later than 300 days after that audit.

Accordingly, in this final rule, Sec. 149.2(d)(2) states more clearly that a Stage II or Stage III site can continue in the program after a change in ownership initially as a Stage II site following a satisfactory audit, and that a new program anniversary date for that site will be established based on the date the site was audited to continue in the program as a Stage II certified site. The producer of the site will then arrange for a site audit to gain (or regain) Stage III certified status based on that new anniversary date and according to the timetable prescribed in Sec. 149.3(e).

In proposed Sec. 149.2(e)(ii), we stated that, no more than once every two years, a producer may request that one or more certified production sites be temporarily withdrawn from the program. In order to obtain a withdrawal, the producer would have to submit a request in writing to the Administrator.

During the period of withdrawal, swine from the site would not be able to be identified as certified products from a certified production site, but the producer would still have to continue to adhere to all good production practices and other program requirements, unless the Administrator specifically waived a certain requirement in granting the withdrawal.

Before being reinstated, that is, while still under temporary withdrawal status, the site would have to pass a site audit to indicate that it is adhering to all good production practices (including any practices previously waived by the Administrator). If swine 5 weeks of age or older originating from noncertified sources are received at the site during the time of withdrawal, then the site audit for reinstatement must be performed within 30 days of the date the last swine from noncertified sources was removed from the site, but no later than 180 days from the date the site was granted temporary withdrawal status. A site found during the audit not to be adhering to one or more of the good production practices, including any waived during the period of withdrawal, would be subject to decertification.

In reviewing our proposal, we have determined that these provisions appear contradictory, insofar as we require a temporarily withdrawn site to adhere to all the good production practices and program requirements, unless a requirement is explicitly waived by the Administrator, yet seem to allow all temporarily withdrawn sites to receive swine 5 weeks of age or older from noncertified sources, in contravention of one of the good production practices.

We intended these provisions to allow a temporarily withdrawn site to receive swine from a noncertified source, only if the Administrator specifically waived the good production practice prohibiting such reception in granting the producer's request for withdrawal. Therefore, in this final rule, Sec. 149.2(e)(ii) now explicitly states that, in order to maintain status in the program, a temporarily withdrawn production site must obtain a waiver from the Administrator before receiving swine 5 weeks of age or older from a noncertified source.

In proposed Sec. 149.4, we stated that all certified production sites would be subject to spot audits. Spot audits may be performed at random to verify the integrity of the program or, in some cases, to trace back and investigate a positive test result that results from the testing of certified swine from that site at a slaughter facility. In reviewing our proposal, we realize that we failed to state whether a spot audit of a site will affect the timetable that site was following for the completion of subsequent site audits, i.e., whether a new anniversary date will be instituted for the site based on the date that it undergoes the spot audit.

Sites subjected to a spot audit will maintain the same timetable for completion of site audits that they had prior to the spot audit. The reasons for this are twofold, depending on the nature of the spot audit. A site that is the source of certified swine that test positive for trichinae under 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 Sec. 149.4 now specifies that unless a spot audit results in decertification, it does not otherwise affect the timetables for the completion of site audits set forth in this rule. [[Page 60472]]

In proposed Sec. 149.3(a)(5) and proposed Sec. 149.8(a)(1), we stated that, if a QAV performs a site audit, the producer will pay the QAV directly at a mutually agreedupon time and rate. In reviewing our proposal, we have determined that this provision presupposes that a QAV will charge a producer for the cost of each site audit, and could be construed to specify the nature of the agreement that would occur between the two parties. For these reasons, we have removed this provision from the two paragraphs. Similarly, since a QAV may decide not to charge a producer for the cost of a site audit, we have removed statements in the same proposed paragraphs that a producer is responsible for the cost of the site audit.

Finally, in a related matter, in proposed Sec. 149.3, we twice stated that a producer ``may'' have to contact either a QAV or QVMO in order to conduct a site audit. In proposed paragraph (c)(1), we stated that, when a producer and the producer's herd health personnel believe that a site meets program standards, the producer may arrange for an initial site audit, while, in proposed paragraph (a)(1), we stated that, if a QAV is not available to perform this site audit, the producer may then contact the APHIS area office to request that a QVMO perform the audit.

In reviewing our proposal, we have determined that the use of ``may'' in these two paragraphs could be construed as allowing a producer to forego an initial site audit and yet still become enrolled in the program. This is not the case. We have therefore replaced ``may'' with ``must'' in these two paragraphs.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

In accordance with the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the authority to promulgate regulations and conduct programs to detect, control, or eradicate any pest or disease of livestock (including the drawing of blood and diagnostic testing of animals). Such programs can include animals at a slaughterhouse, stockyard, or other point of concentration. The Secretary may also cooperate with State authorities, Indian tribal authorities, or other persons in the administration of regulations for the improvement of livestock and livestock products.

In accordance with 21 U.S.C. 601 et seq., the Secretary of Agriculture is authorized to inspect meat and meat products at any slaughtering, packing, meatcanning, 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

FOR FURTHER INFORMATION CONTACT Dr. Dave Pyburn, National Trichinae Coordinator, VS, APHIS, 210 Walnut Street, Room 891, Des Moines, IA 50309; (515) 2844122.