[Federal Register: May 16, 2007 (Volume 72, Number 94)] [Proposed Rules] [Page 27655-27686] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16my07-37] [[Page 27655]] ----------------------------------------------------------------------- Part VI Department of Agriculture ----------------------------------------------------------------------- Animal and Plant Health Inspection Service ----------------------------------------------------------------------- 9 CFR Parts 149, 160 and 161 Trichinae Certification Program; Proposed Rule [[Page 27656]] ----------------------------------------------------------------------- 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: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to establish a voluntary Trichinae Certification Program for U.S. pork that has been produced under disease-prevention conditions. Under the proposed program, we would certify pork production sites that follow prescribed good production practices that reduce, eliminate, or avoid the risk of exposure of animals to the zoonotic parasite Trichinella spiralis, a disease of swine. Such a program should enhance the ability of producers to export pork and pork products to overseas markets. This proposed program, which would be funded by program fees, has been developed as a cooperative effort by the U.S. Department of Agriculture, the National Pork Board, and the pork processing industry. If adopted, this program would 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: We will consider all comments that we receive on or before July 16, 2007. ADDRESSES: You may submit comments by either of the following methods: Federal eRulemaking Portal: Go to http://www.regulations.gov , select ``Animal and Plant Health Inspection Service'' from the agency drop-down menu, then click ``Submit.'' In the Docket ID column, select APHIS-2006-0089 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's ``User Tips'' link. Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS- 2006-0089, Regulatory Analysis and Development, PPD, APHIS, Station 3A- 03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0089. Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming. Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. 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 Under the Animal Health Protection Act (7 U.S.C. 8301-8317), the Administrator of 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 tribe authorities, or other persons in the administration of regulations for the improvement of livestock and livestock products. For example, APHIS administers regulations in subchapter G of chapter I, title 9, of the Code of Federal Regulations (CFR) that address poultry improvement through the National Poultry Improvement Plan (NPIP). The NPIP is a cooperative Federal-State-industry mechanism consisting of a variety of programs intended to prevent and control egg-transmitted, hatchery-disseminated poultry diseases. As a result, customers can buy poultry or poultry products from flocks that have been certified free of certain diseases or produced under disease-prevention conditions. APHIS' regulations in 9 CFR parts 160 through 162 govern the accreditation of veterinarians. Accredited veterinarians are approved by the APHIS Administrator to perform certain regulatory tasks to control and prevent the spread of animal diseases throughout the United States. Under the Federal Meat Inspection Act (FMIA), as amended (21 U.S.C. 601 et seq.), and the Poultry Products Inspection Act (PPIA), as amended (21 U.S.C. 451 et seq.), the USDA's Food Safety and Inspection Service (FSIS) inspects meat and poultry slaughtered or processed at official establishments. Such inspection is required to ensure the safety, wholesomeness, and proper labeling of meat and poultry. In addition to mandatory inspection, FSIS, under the authority of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), provides a range of voluntary inspection, certification, and identification services to assist in the orderly marketing of various animal products and byproducts. FSIS regulations covering inspection and other related activities are found at 9 CFR chapter III. Under the Agricultural Marketing Act of 1946, USDA's Agricultural Marketing Service (AMS) provides analytical testing services that facilitate marketing and allow products to obtain grade designations or meet marketing or quality standards. Pursuant to this authority, AMS develops and maintains laboratory certification and approval programs as needed by the agricultural industry, to support domestic and international marketing of U.S. products. Trichinae In Swine Trichinella spiralis is a parasitic nematode (roundworm) that is found in many warm-blooded carnivores and omnivores, including swine. Trichinae is a generic term that refers to Trichinella spiralis. Trichinae has a direct life cycle, which means it completes all stages of development in one host. Transmission from one host to another host can only occur by ingestion of muscle tissue that is infected with the encysted larval stages of the parasite. When ingested, muscle larvae are freed from the cyst by digestion in the stomach and then enter tissues of the small intestine, where they undergo development to the adult stage. Male and female adult parasites mate, and the females produce newborn larvae that leave the intestine and migrate through the host circulatory system to striated muscle tissue. There, the larvae penetrate a muscle cell, modify it to become a unique cyst, and mature to become infective for another host. The total time required for this to occur is from 17 to 21 days. Adult males die after mating, but adult females continue to produce larvae in the host for several weeks before they die and are expelled. Once adult worms are expelled and larvae reach and encyst in musculature, [[Page 27657]] no further contamination can occur. Animals that are infected with trichinae are at least partially resistant to a subsequent infection due to a strong and persistent immunity. Trichinae may be passed on to humans who consume undercooked meat infected with the encysted parasite. Humans who are infected with the parasite generally experience flu-like symptoms, such as fever. Trichinae has a longstanding association with swine and pork products, not only in the United States but around the world. The concept that many people have about the need to cook pork thoroughly is based on the risk of becoming infected with this parasite. The historical problem of trichinae infection in swine is the basis for strict Federal regulations relating to the methods used to prepare ready-to-eat pork products. Despite the historical problems of trichinae and its association with the pork industry, changes have occurred in the last 50 years that have caused a major decline in the prevalence of this parasite in swine raised in the United States. Historically, trichinae infection in swine was associated with feeding them raw meat waste products. Major inroads with respect to the reduced incidence of trichinae infection occurred with the advent of meat waste cooking laws in response to vesicular exanthema (1953-1954) and the hog cholera eradication program (1962). Of equal importance has been the movement to high levels of biosecurity and hygiene under which most U.S. swine are now raised as producers increasingly use intensive management systems in raising swine. Despite the fact that trichinae is rare in today's U.S. swine industry, pork still suffers from its historical association with the parasite. Today, the trichinae issue is a question of perception versus reality. Human cases of trichinellosis reported to the Centers for Disease Control and Prevention declined from about 500 per year in the 1940's to fewer than 50 per year over the last decade. Further, many of these cases resulted from non-pork sources such as bear and other game meats. However, the dramatic declines in the prevalence of trichinae in U.S. swine and the extremely low number of cases in humans in the United States remain largely unrecognized by consumers and our trading partners. Today, exposure of domestic swine to trichinae is limited to just a few risk factors that include: Consumption by swine of uncooked meat waste products contaminated with trichinae, consumption of rodents or other wildlife infected with trichinae, and cannibalism among swine within an infected herd. Generally, the way that swine become infected can be determined by a simple evaluation of farm management practices. Since it is illegal to feed raw meat waste products to swine, this particular source of infection should never be an issue. However, feeding of any raw or undercooked meat scraps, including table waste, does pose a risk. Of much greater significance is the exposure of swine to rodents and wildlife infected with trichinae. Rodents, and rats in particular, serve as a reservoir host for trichinae infection. Rodents can pick up infection from landfills, carrion, or even dead swine. When rat populations are in close proximity to swine, it is possible that either live or dead rats will be caught and eaten by the swine. If the rat happens to be infected, then trichinae infection will occur. The same type of risk holds true for other small mammals. Swine that have free range to browse outdoors occasionally encounter carcasses that they may consume. Small mammals that have been shown to have higher prevalence rates for trichinae include raccoons, skunks, and opossums. The risk of exposure of swine to trichinae at the production site can be greatly reduced, if not eliminated, by taking the following steps: Do not feed uncooked waste products, table scraps, or animal carcasses to swine. This is particularly important in the case of carcasses from hunted or trapped wildlife. Eliminate or minimize the exposure of swine to live wildlife. Create barriers that are effective in separating swine from skunks, raccoons, and other small mammals. Implement and maintain an effective rodent control program at the pork production site. Biosecurity, maintaining perimeters, baiting, and trapping are all part of rodent control. Maintain good hygiene at the pork production site. Remove dead swine as soon as they are found. Keep barns free from clutter and store feed securely. Trichinae Control Despite the relatively low prevalence of trichinae in swine in many developed countries, considerable energy goes into preventing human exposure to this parasite. There are a variety of ways in which trichinae control is approached. A number of countries require slaughter testing of each carcass. In fact, for pork exported to the European Union (EU), packers in the United States test carcasses using the same methods employed by European meat inspectors. While the need for such measures may no longer seem as immediate, given that trichinae is almost nonexistent in U.S.-produced pork, it is apparent that some organized approach to demonstrating product safety is still needed for overseas markets. The following discussion summarizes the potential methods that are currently used for trichinae control. Slaughter Testing Many countries require slaughter testing of each carcass. Such testing is largely a continuation of measures implemented when trichinae was a serious problem. In many countries, slaughter inspection programs are required. Approved slaughter testing methods for trichinae in swine include direct methods for visualization of parasites. Since it is not possible to see trichinae cysts within meat tissue by macroscopic examination, it is necessary to perform one of several laboratory tests. The oldest method, and one still frequently used, is called the compression method. Small pieces of pork collected from the pillars (crus muscle or hanging tenderloin) of the diaphragm are compressed between two thick glass slides (a compressorium) and examined microscopically for the presence of Trichinella spiralis larvae. An improvement over the compression method, and a method that is now widely used in Europe, is the pooled sample digestion method. Samples of tissue collected from sites where parasites concentrate, such as the diaphragm, masseters, or tongue, are subjected to digestion in acidified pepsin. Larvae, which are freed from their muscle cell cysts by this process, are recovered by a series of settling steps, then visualized and counted under a microscope. Requirements for performing the digestion test are found in the Directives of the European Economic Community, in the FSIS regulations in 9 CFR 318.10(e), and in various other publications. Another method of testing swine for trichinae infection is an indirect method that looks for antibodies to the parasites in swine sera, plasma, whole blood, tissue fluid, or meat juice. The enzyme- linked immunosorbent assay (ELISA) method has been used extensively for testing in both pre- and post-slaughter applications and is an extremely useful tool for determining or monitoring trichinae infection in herds. Where fresh pork is not routinely tested for trichinae, as is the case in the United States, alternative measures are used to prevent exposure of humans to potentially contaminated product. These include processing methods such [[Page 27658]] as cooking, freezing, irradiation, and curing along with recommendations to the consumer concerning the need for thorough cooking. In lieu of carcass testing or treatment to show that swine or pork product is not infected or contaminated, there are still other means to ensure the safety of the product. These include herd testing to prove that trichinae infection is not present in a particular geographical region (i.e., certification by region) or raising swine under prescribed conditions that reduce, eliminate, or avoid the risk of exposure of swine to trichinae (i.e., certification of individual pork production sites). In the former case, considerable testing on a regular basis is required to document the absence of infection. In the latter case, documentation of good production practices is necessary to show that swine have not had an opportunity to become exposed to or infected with trichinae. Certification By Region The basis for a regional approach to certification is found in the Office International des Epizooties (OIE) International Animal Health Code. (Recommendations relating to Trichinellosis (Trichinella spiralis) appear in Part 2, Article 2.2.9.3 of the International Animal Health Code, 2001.) The OIE Code provides that domestic swine in a country, or part of the territory of a country, may be considered free from trichinae based on the following factors: Trichinellosis in humans and animals must be reported; there is an effective disease reporting system in place that has proven to be capable of capturing the occurrence of cases; and it has been found that trichinae infection does not exist in the domestic swine population based on regular testing of a statistically significant sample of the population, or trichinellosis has not been reported in 5 years and a surveillance program shows that the disease is absent from wild animal populations. As noted previously, the United States has an extremely low incidence of trichinae infection in swine. Although human trichinellosis is a reportable disease, the United States has no history of regular testing to determine trichinae infection in swine, nor do most States require the reporting of trichinae infection in swine when detected. Because a number of countries, such as those in the EU, require some form of testing for trichinae, implementing a trichinae control program in the United States would remove certain obstacles faced by exporters of U.S.-produced pork. One way to accomplish this goal within a reasonable timeframe would be to certify that herds were produced under the requirements of the Trichinae Certification Program and based on the use of good production practices that reduce, eliminate, or avoid the risk of exposure of swine to trichinae infection. Recent research efforts and pilot studies involving APHIS, FSIS, USDA's Agricultural Marketing Service (AMS), Agricultural Research Service (ARS), and Cooperative State Research, Education, and Extension Service (CSREES), the National Pork Board, and other private industry and packer groups have led to the development of a program for certification of swine from pork production sites. Certification of swine as produced under the requirements of the Trichinae Certification Program is contingent on pork production sites following certain good production practices that reduce, eliminate, or avoid risk factors for the transmission of trichinae to swine, as well as systematic monitoring and testing of the product at the slaughter facility. The concept of risk management for control of Trichinella spiralis in the domestic swine population is endorsed by the U.S. Animal Health Association, the National Institute for Animal Agriculture, and the American Association of Swine Veterinarians. A program for the certification of pork production sites that follow good production practices incorporates many of the principles of a Hazard Analysis and Critical Control Points or ``HACCP'' system. The specific hazard is the risk of exposure of swine to Trichinella spiralis. The critical control points in addressing this hazard, which are based on a number of studies on the epidemiology of trichinellosis and its transmission to domestic swine, focus on addressing those practices that potentially allow swine to ingest raw or undercooked meat waste products or rodents or animal carcasses that contain trichinae. The certification process in this type of program encompasses the following basic steps: Accredited veterinarians trained in good production practices relative to exposure to trichinae work with producers to ensure that trichinae risk factors are reduced, eliminated, or avoided at pork production sites; The site audit performed by trained USDA-accredited veterinarians serves as a method to document that risks of infection are eliminated or satisfactorily controlled. Audits need to be done periodically to ensure that good production practices relative to trichinae control remain in place; On a regular basis, a statistically valid sample of the total number of swine from certified production sites is tested at the slaughter facility laboratory or some other onsite or offsite laboratory using licensed or accepted testing methods to verify the absence of trichinae infection; and QVMOs perform random ``spot audits'' of certified production sites to ensure the overall integrity and consistency of the program. The regular site audit takes into account those management practices that affect the risk of exposure of swine to trichinae, such as feed integrity (i.e., source and storage), building construction and condition as it pertains to biosecurity, integrity of rodent control programs, and general management and hygiene factors as they pertain to rodent control, swine cannibalism, and other issues. As a part of the process of raising swine under good production practices, the producer needs to maintain certain records that document its adherence to good production practices, with those records being verified in the site audit. The producer also is responsible for adhering to good production practices between site audits. A pilot program for the certification of pork production sites as being produced under the requirements of the Trichinae Certification Program that involved the above-mentioned agencies of USDA, as well as private industry, was conducted in Iowa, Minnesota, and South Dakota in 1997 and 1998. The purpose of the pilot program was to evaluate a process-verification system for the production of pork. An on-farm audit, consisting of 55 questions, was developed to identify those risk factors that could expose swine to Trichinella spiralis. The audit was administered by USDA-trained accredited veterinary practitioners at 198 pork production sites in the 3-State area. All swine raised on sites where audits were conducted were slaughtered at a single packing plant and a sample from each carcass was tested by the pooled sample digestion and ELISA methods. Few production sites met all criteria established within the audit for good production practices similar to those proposed in this document. Most of the deficiencies related to the absence of a regular rodent control program around and in swine production facilities. However, it was determined that more than 85 percent of these sites could meet good production practice criteria with minor improvements in site management. From a total of 221,123 carcass samples tested from farms audited during a 6-month period, no trichinae-positive carcasses were [[Page 27659]] detected by digestion or ELISA methods. Based on the outcome of this pilot program, an improved, more succinct audit was developed with objective measures for those good production practices that reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spiralis. This revised version of the site audit is currently being used in a second pilot program involving pork production sites located in Colorado, Illinois, Iowa, Minnesota, Missouri, Nebraska, Oklahoma, and South Dakota that are supplying swine to a slaughter facility in Iowa. This second pilot program began in December of 2000. Pork product sites were selected based on their willingness to participate in the program. As of December 2004, there were approximately 125 sites participating in the program. Program sites have completed one or more official pilot audits conducted by qualified accredited veterinarians that indicate the site is following certain good production practices designed to reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spiralis. The slaughter facility in Iowa has conducted verification testing on swine carcasses from a statistically valid sample of the participating sites that have attained ``certified'' status. Close to 100 accredited veterinarians have also been trained as site auditors during this period. The primary purpose of this second pilot program is to verify the adequacy of the selected good production practices in minimizing, reducing, or eliminating the risk of exposure of swine to Trichinae spiralis, as well as to confirm that the site audit and slaughter plant sample testing protocols provide a dependable means of verifying that good production practices are being followed. This second pilot program will continue until rulemaking establishes the Trichinae Certification Program. Collaboration with AMS and FSIS As previously stated, APHIS has collaborated with FSIS and AMS, among other entities, in developing a program for certification of swine from pork production sites. This collaboration included the research efforts of AMS as well as their continuing role in training laboratory technicians who work in slaughter facilities on how to conduct trichinae ELISA tests. FSIS has supported the trichinae program through its research efforts at the beginning of the pilot program and its direct participation in the program at federally inspected slaughter facilities. Moreover, in a proposed rule published in the Federal Register on February 27, 2001 (66 FR 12590-12635), FSIS, in proposing to remove prescriptive trichinae treatment requirements in favor of performance standards, pointed to the program as one means by which establishments that produce pork products can ascertain whether their suppliers have taken measures to prevent trichinae infection of their herds. In that document, FSIS also discussed its role in verifying that processors properly check status of pigs, testing samples as required, and maintaining adequate animal identification and records under the program. Both AMS and FSIS have been important and willing partners in this pilot program, and we expect this collaboration to continue. As a result of the cooperative research efforts and pilot programs just referenced, we are proposing to establish regulations for a voluntary Trichinae Certification Program to appear as a new part 149 in 9 CFR subchapter G of the regulations. The current title of Subchapter G, ``Poultry Improvement'', would be changed to ``Livestock Improvement'' to reflect that the subchapter's regulatory coverage would now encompass animals other than poultry. The proposed 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 spiralis. In addition to establishing a new part 149, we also would make certain changes to existing regulations in 9 CFR parts 160 and 161 covering the accreditation of veterinarians that are needed for this Trichinae Certification Program. The full text of the proposed regulations appears in the rule portion of this document. Our discussion of the proposed provisions follows. Purpose and Scope Proposed Sec. 149.0 would provide that the Trichinae Certification Program described in part 149 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 overseas markets. We would include this statement in the regulations because, although we recognize that producers may wish to participate in the program for domestic marketing purposes, such uses would be outside the scope of APHIS' authority. Any domestic marketing uses of the program, such as the labeling of products, would have to be conducted in accordance with the regulations of FSIS and AMS. Definitions Proposed Sec. 149.1 would contain definitions for the terms used in part 149. We would define an accredited veterinarian as a veterinarian approved by the APHIS Administrator in accordance with 9 CFR part 161 to perform functions specified in 9 CFR, chapter I, subchapters B, C, D, and G. The term Agricultural Marketing Service or AMS would refer to the Agricultural Marketing Service of the United States Department of Agriculture, while the AMS Administrator would refer to the Administrator, Agricultural Marketing Service, or any person authorized to act for the AMS Administrator. An AMS representative would be defined as 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 the services required by proposed part 149. The term Animal and Plant Health Inspection Service or APHIS would refer to the Animal and Plant Health Inspection Service of the United States Department of Agriculture. An animal disposal plan would be defined as a written document that describes methods for the removal and disposal of dead swine or swine remains from a pork production site, while an animal movement record would be defined as a written record of the movement of swine into or from a pork production site. The term APHIS Administrator refers to the Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the APHIS Administrator, while an APHIS representative would refer to 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 proposed part 149. We would define an approved laboratory as 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. The term audit would be defined as an inspection process, as provided in proposed part 149, that generates a written record documenting a pork production site's adherence to the required good production practices. [[Page 27660]] There would be two types of audits, a site audit and a spot audit, both of which are defined below. An auditor would be defined as 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. The term certification or certified would refer to the designation given by the APHIS Administrator to a pork production site that has been determined to be in compliance with the specific good production practices and other program requirements of the Trichinae Certification Program as provided in part 149. The term certified pork would refer to pork or pork products originating from certified swine from a certified production site with identity of such animals or carcasses maintained throughout receiving, handling, and processing.\1\ --------------------------------------------------------------------------- \1\ The labeling of all certified pork or pork products leaving a slaughter or processing facility must comply with 9 CFR 317.4 and all other applicable FSIS labeling regulations. --------------------------------------------------------------------------- A certified production site would be defined as 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 proposed part 149. The term certified swine would refer to swine produced under the Trichinae Certification Program on a certified production site. The term decertification or decertified would be defined as the 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 or ELISA would refer to a method of testing swine for the presence of trichinae infection by looking for antibodies to Trichinella spiralis in the sera, plasma, whole blood, tissue fluid, or meat juice of swine. The term EPA would refer to the United States Environmental Protection Agency. A feed mill quality assurance affidavit would be defined as 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 or FSIS would refer to the Food Safety and Inspection Service of the United States Department of Agriculture, while the FSIS Administrator would refer to the Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. An FSIS program employee would be defined as 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 under proposed part 149. The term good manufacturing practices would be defined as feed manufacturing practices that reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spiralis, while the term good production practices would refer to pork production management practices that reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spiralis. The term harborage would be defined as any object, debris, clutter, or area that could serve as shelter or refuge for rodents or wildlife. We would define a laboratory approval audit as 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 proposed part 149. We would define National Trichinae Certified Herd as all swine raised on certified production sites in the United States. The term person would be defined as any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity. A pest control operator refers to a person trained and State- licensed in the control of pests and vermin (particularly rodents). Pooled sample digestion method or digestion method would refer to a method of testing swine for trichinae infection by identifying the presence of Trichinella spiralis from a sample of the animal's muscle tissue. We would define a pork production site or site as 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 swine housing and feeding areas. The term positive test result would mean the outcome of a validated test indicating the presence of Trichinella spiralis. The term process-verification testing would refer to the 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 spiralis infection in swine from that herd. We would define a producer as an individual or entity that owns or controls the production or management of swine. A qualified accredited veterinarian or QAV would refer to an accredited veterinarian who has been granted an accreditation specialization by the APHIS Administrator pursuant to 9 CFR 161.5 based on completion of an APHIS-approved orientation or 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 in proposed part 149. A qualified veterinary medical officer or QVMO would refer to 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 in proposed part 149. The term rodent control logbook would be defined as a written record that documents a rodent control program for a pork production site. We would define a site audit as 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 spiralis. The term slaughter facility would be defined as 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. We would define the term slaughter facility representative as any individual employed by, or acting as an agent on behalf of, a slaughter facility who is authorized by the slaughter facility to perform specified program services required in proposed part 149. A spot audit would refer to an audit of a certified pork production site performed by a QVMO to ensure program integrity and consistency. Pork production sites that are in the Trichinae Certification Program would be assigned a particular program status as either a Stage I enrolled site, a Stage II certified site, or a Stage III certified site. The term Stage I enrolled would refer to the preliminary program status [[Page 27661]] of a pork production site attained when the APHIS Administrator approves the outcome of an initial site audit. We would define the term Stage II certified as that program status attained upon APHIS approval of a site audit of a Stage I enrolled site, while the term Stage III certified would refer to 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. The term sterile zone would be defined as an open area immediately adjacent to and surrounding those building(s) used to house and feed swine that serves as both a buffer and detection zone for rodent and wildlife activity. The term temporary withdrawal would be defined as 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 would be defined as a generic term that refers to Trichinella spiralis. We would define Trichinae Certification Program or program as 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 spiralis. The Trichinae Identification Number or TIN would be a number assigned to a pork production site by the APHIS Administrator. We would define the term Trichinella spiralis as a parasitic nematode (roundworm) capable of infecting many warm-blooded carnivores and omnivores, including swine. The abbreviation USDA would refer to the United States Department of Agriculture. The term validated test would be defined as an analytical method licensed by APHIS or accepted by AMS for the diagnosis of Trichinella spiralis in swine. A veterinary medical officer or VMO would be defined as a veterinarian employed by the State or Federal Government who is authorized to perform official animal health activities on their behalf. We would define a waste feeding logbook as a written record that documents the presence of good production practices with respect to the feeding of meat-containing waste to swine and compliance with applicable State and Federal food waste feeding laws and regulations. Program Participation Proposed Sec. 149.2 would provide information on producer participation in the trichinae certification program. A producer's initial enrollment and continued participation in the program would require that the producer adhere to all of the required good production practices, as confirmed by periodic site audits, and comply with other recordkeeping and program requirements provided in proposed part 149. Pork production sites accepted into the program by APHIS would participate under one of the following three program stages: Stage I enrolled, Stage II certified, or Stage III certified. Stage I Enrolled Status Under proposed Sec. 149.2(a), attaining Stage I enrolled status would signify that a pork production site has met all of the required good production practices and other recordkeeping and program requirements provided in part 149. Although enrolled in the program, Stage I enrolled sites would not be able to identify their swine as products from a certified production site. If a Stage I enrolled site is found not to be adhering to one or more good production practices as a result of a site audit or a spot audit, or 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, it would lose its status as a Stage I enrolled site. As provided in Sec. 149.3(d), the site audit must be performed no sooner than 150 days from the date the site was awarded Stage I enrolled status, and must be completed, with the audit form and payment submitted to APHIS, no later than 210 days from the date the site was awarded Stage I enrolled status. Stage II Certified Status Under proposed Sec. 149.2(b), attaining Stage II certified status would signify that a pork production site is adhering to all of the required good production practices and complies with other recordkeeping and program requirements provided in part 149. An APHIS- issued certificate or letter indicating the site's status as a Stage II certified site would have to be filed at the site and be readily available for inspection. Once a site attains Stage II certified status, it would then be able to identify its swine as certified product from a certified production site. 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 a 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 III certified site, would be decertified by APHIS and would be ineligible to identify swine from that site as certified product from a certified production site. As provided in Sec. 149.3(e), a Stage II certified site must complete a site audit for Stage III certified status. Under Sec. 149.3(e), the site audit must be performed no sooner than 240 days from the date the site was awarded Stage II certified status, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days from the date the site was awarded Stage II certified status. As further provided in Sec. 149.2(e), once a site is decertified, the producer would have to repeat the process of requesting a new site audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage I site audit, then a new program anniversary date for that site would be established based on the date of enrollment and the site would be reinstated at Stage II status. Stage III Certified Status Proposed Sec. 149.2(c) would cover sites attaining Stage III certified status. The primary distinction between Stage II and Stage III certified sites would be that once a site is awarded Stage III certified status, it would not be required to undergo another site audit for recertification for another 14 to 16 months. In contrast, a Stage II certified site would have to undergo another site audit 8 to 10 months after it receives its Stage II certification. We would allow a longer period to elapse between site audits for Stage III sites based on their record of already successfully completing site audits at the Stage I and Stage II program levels. All other aspects of Stage III certification would be the same as described above in the discussion of Stage II certification. Change in Ownership Proposed Sec. 149.2(d) would provide the steps to be taken in the event there is a change of ownership in a site participating in the program. 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 would continue on the same timetable as under the previous ownership for completing a site audit for Stage II certified status. No additional site audit would be required as a result of the change of ownership since another site audit would occur anyway within 6 months or less if the site intends to remain in the program. [[Page 27662]] If there is a change of ownership in a Stage II or Stage III certified site, however, we would require that a site audit be performed within 60 days of the ownership change in order for the site to maintain its certified status. If the site audit is satisfactory, then the Stage II or Stage III certified site would continue in the program only as a Stage II certified site. We would require a Stage III certified site to revert to Stage II certified status after a change in ownership so that the site would have another site audit within 1 year's time. This would provide us with greater assurances that the new ownership is adhering to the good production practices. A new program anniversary date for purposes of performing future audits would be established based on the date the site was audited to continue in the program as a Stage II certified site. If the results of a site audit following a change in ownership are not satisfactory, then the site would be decertified by APHIS. Should the producer wish to participate in the program once again, he or she would have to request a new site audit for Stage I enrolled status once the particular deficiencies have been resolved. If a site is decertified by APHIS, but is reenrolled after a successful Stage I site audit, then a new program anniversary date for the site would be established based on the date of reenrollment. Site Decertification and Program Withdrawal Proposed Sec. 149.2(e) would cover site decertification by APHIS, as well as voluntary site decertification and voluntary program withdrawal initiated by the producer. Decertification by APHIS In proposed Sec. 149.2(e)(1), 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 a 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, would be decertified by APHIS. Once a site is decertified, swine from that site could not be identified as certified product from a certified production site. In order to participate in the program once again, the producer would have to follow the procedures for requesting an initial site audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage II site audit, then a new program anniversary date for that site would be established based on the date of reenrollment. Temporary Withdrawal by Producer Proposed Sec. 149.2(e)(2) would provide that a producer may request that one or more of their certified production sites be temporarily withdrawn from the program. A producer might choose this option because he or she foresees not having access to animals from certified sources on a temporary basis. A producer's request to have a site temporarily withdrawn would have to be made in writing and would be subject to the APHIS Administrator's approval. Each site could be temporarily withdrawn no more than once every 2 years for a period not to exceed 180 days. While a site is temporarily withdrawn, the producer could not identify swine from that site as certified product from a certified production site. However, the producer would still have to adhere to all good production practices and other program requirements while the site is temporarily withdrawn, unless specifically waived by the Administrator. This would include providing documentation in the animal movement record of the arrival and departure of all swine from the site, as well as whether the swine arriving at the site are from certified or noncertified sources. Before being reinstated as a certified production site, the temporarily withdrawn 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 would have to 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 temporarily withdrawn status. If the site audit is satisfactory and it is determined that the site is adhering to good production practices and other program requirements, then the site would be reinstated as a Stage II certified site (regardless of the site's previous status as a Stage II or Stage III certified site). The timetable for performing future site audits for attaining and renewing Stage III certified status would be based on the date the site was reinstated as a Stage II certified site. If the site audit for reinstatement as a certified production site is not satisfactory due to the producer's failure to adhere to one or more good production practices, or if the period of temporary withdrawal has exceeded 180 days, then the site would be decertified by APHIS. Once the site is withdrawn by APHIS, the producer would have to request an initial site audit for Stage I enrolled status in order for the site to be reenrolled in the program. If a site is withdrawn by APHIS and then reenrolled after a successful Stage I site audit, then a new program anniversary date for that site would be established based on the date of reenrollment as a Stage I enrolled site. Program Withdrawal Under proposed Sec. 149.2(e)(3), if a producer decides to withdraw one or more pork production sites from the program, then the producer would have to notify the APHIS Administrator in writing of this intent. Once this is done, the site would be removed from the program. If at a later date the producer requests that the site be reinstated in the program, then the producer would have to follow the procedures for requesting an initial audit for Stage I enrolled status. If the site is reenrolled after a successful Stage I site audit, then a new program anniversary date for that site would be established based on the date of reenrollment. Request for Review Under proposed Sec. 149.2(f), 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 APHIS Administrator. The producer would have to 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 would remain in force pending the completion of the Administrator's review. The decision by the Administrator upon reviewing the producer's written request would be final. Site Audit Proposed Sec. 149.3 would contain more specific information on performing site audits. Proposed Sec. 149.3 also would describe all of the required good production practices that would be the primary basis for determining whether a site can participate in the program. [[Page 27663]] General Proposed Sec. 149.3(a) would set forth the procedures for arranging and performing a site audit, as well as the process for providing notification of the audit results. This paragraph would apply to sites seeking status as a Stage I enrolled or a Stage II certified site, as well as sites seeking or renewing their status as a Stage III certified site. The producer would be responsible for contacting a QAV to request a site audit. A list of available QAVs could be obtained by accessing the Trichinae Certification Program Web site on the Internet at http://www.aphis.usda.gov/vs/trichinae , or by contacting the APHIS area office. Telephone numbers for APHIS area offices can be found in local telephone books or on the Internet at http://www.aphis.usda.gov/vs/area_offices.htm. If a QAV is not available to perform a site audit, the producer could then contact the APHIS area office to request that a QVMO perform the site audit. The site audit would be arranged at a mutually agreed-upon time. We also would require that the producer or the producer's designated representative accompany the auditor during the site audit. While performing the site audit, the auditor would record whether the producer is adhering to good production practices at the site, as discussed below in proposed Sec. 149.3(b), that reduce, eliminate, or avoid the risk of exposure of swine to Trichinella spiralis. In performing the site audit, the auditor would use APHIS-approved audit forms. Once the auditor has completed all sections of the audit form, the producer or the producer's designated representative would have to sign the audit form attesting to the accuracy of the information obtained during the site audit. The producer's signature also would evidence his or her intent to continue adhering to the good production practices and other program requirements. The auditor also would sign the audit form at this time. The producer would be responsible for the cost of each site audit performed at the pork production site. If a QAV performs the site audit, then the producer would pay the QAV directly at a mutually agreed-upon time and rate. If a QVMO performs the site audit, then the producer would 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. In the case of a site audit performed by a QVMO employed by APHIS, the producer would pay APHIS by certified check or U.S. money order for this service at a rate determined in accordance with proposed Sec. 149.8. In addition to the cost of the site audit, the producer also would have to pay a separate fee, as specified in proposed Sec. 149.8, to cover APHIS' administrative costs in processing the audit and operating the program. We are proposing a program fee of $51, payable to APHIS by certified check or U.S. money order, to be remitted to the auditor at the time each site audit is performed. To arrive at the program fee of $51, APHIS examined costs associated with the pilot program and itemized those costs based on 127 applications processed during the pilot program.\2\ --------------------------------------------------------------------------- \2\ FSIS and AMS would not charge any additional program fees for the site audit, however, FSIS does charge $15 for export certificates. --------------------------------------------------------------------------- The basic steps in the calculation for each particular service are: (1) Calculate direct labor costs by determining the average amount of direct labor required to perform the service and multiply the average direct labor hours by the average salary and benefit costs for employees; (2) calculate the pro rata share of administrative support costs; (3) determine the premium costs (if any); (4) calculate the pro rata share of agency overhead and departmental charges, respectively, including the salary of the National Coordinator; (5) add all costs; and (6) round up to the next $0.25 for all fees less than $10 or round up or down to the nearest dollar for all fees greater than $10. Table 1 below shows how APHIS arrived at this rate. Table 1.--Costs Considered in Arriving at the $51 Program Fee [Based on 127 applications processed] ---------------------------------------------------------------------------------------------------------------- Hourly Number of salary (FY Benefits Direct ---------------------------------------------------------------------------------------------------------------- Direct Labor: Area Epidemiology Officer \2\........................... 13.23 $42.55 $10.32 $699.58 Clerk \3\............................................... 71.44 16.29 3.95 1,445.77 Inspector \4\........................................... 25.40 29.63 7.19 935.18 Total direct labor costs............................ ........... ........... ........... 3,080.53 --------------------------------------------------- Support costs at 62.31%................................. ........... ........... ........... 1,919.47 --------------------------------------------------- Subtotal............................................ ........... ........... ........... 5,000.00 Agency overhead at 16.15%............................... ........... ........... ........... 807.50 --------------------------------------------------- Subtotal............................................ ........... ........... ........... 5,807.50 Departmental charges at 4.57%........................... ........... ........... ........... 265.40 --------------------------------------------------- Subtotal............................................ ........... ........... ........... 6,072.90 Reserve component....................................... ........... ........... ........... 303.64 --------------------------------------------------- Total full cost for processing 127 applications..... ........... ........... ........... 6,376.54 Full cost per application............................... ........... ........... ........... 50.21 Full cost per application, rounded up to the nearest ........... ........... ........... $51.00 whole dollar........................................... ---------------------------------------------------------------------------------------------------------------- \2\ Includes time to review the application, compare to standards, identify any nonconformities, call the auditor (if necessary), approve/deny application, and sign. \3\ GS 5/step 5 clerk (includes time to process and file paperwork, identify auditing veterinarian, and perform data entry). \4\ GS 11/step 5 inspector (includes time for spot audits). [[Page 27664]] The auditor will submit the completed audit form, program fee, and payment for services (if the auditor was an APHIS-employed QVMO) to the nearest APHIS area office. If a QAV performs the site audit rather than a QVMO, the QAV will submit the completed audit form and program fee to APHIS in a timely manner. Upon receipt of the completed audit form and payment, APHIS would evaluate the site audit and provide the producer with written notification of the audit results. A pork production site found to meet all good production practices and other program requirements would be issued program status at the appropriate program stage. If the audit shows that the site does not meet all good production practices or other program requirements, APHIS would provide the producer with written notification that would include documentation of the deficiencies that prevented the site from being conferred program status. It would be the producer's responsibility to work with a veterinarian or other consultants to correct those deficiencies should the producer seek to enroll in the program at a later time. Good Production Practices Proposed Sec. 149.3(b) would set forth all of the required good production practices that producers would have to adhere to in order to participate in the program. As discussed previously, these good production practices are designed to reduce, eliminate, or avoid those risk factors involving the exposure of swine to Trichinella spiralis. The good production practices would be as follows: The movement of all non-breeding swine 5 weeks of age or older into or from the pork production site would have to be documented in an animal movement record, as provided in proposed Sec. 149.7, that ensures that all such swine moved into or from the site can be subsequently traced back to that site, or to any previous site (if applicable). Additional information relating to the animal movement record is provided below under the heading ``Recordkeeping at Site.'' All non-breeding swine entering a site would have to have originated from another certified production site, except that non- breeding swine less than 5 weeks of age may have originated from a certified or noncertified production site. We would provide this exception because swine less than 5 weeks of age do not as yet eat solid food, and therefore do not present a risk of ingesting the Trichinella spiralis parasite through infected food sources. The animal movement record would have to include the TIN 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 would have to provide the name and full address of the noncertified site where the swine originated. Feed or feed ingredients from offsite sources that are used at the site would have to meet all good manufacturing practices or other quality assurance standards recognized by the feed industry. The adherence to good manufacturing practices or other quality assurance standards would have to be documented in a feed mill quality assurance affidavit. Additional information relating to the feed mill quality assurance affidavit is provided below under the heading ``Recordkeeping at Site.'' Swine housing and feeding areas, feed preparation and storage areas, and office areas and connecting hallways at the site would have to be inspected regularly and found free of fresh signs of rodent and wildlife activity. Any movable rodent harborage (exterior or interior) on the site that is not necessary to the day-to-day operation of the site would have to be removed. Harborage that cannot be removed or is movable but necessary to the day-to-day operation of the site (e.g., bales of hay, etc.) would have to be checked for signs of rodent or wildlife activity. In addition, domesticated animals, including pets such as dogs and cats, would have to be excluded from the swine housing and feeding areas and feed preparation and storage areas at the site. Evidence of rodent activity or rodent infestation would consist 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 would consist 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. Exterior rodent bait stations and/or traps would have to be placed around the perimeter of those building(s) housing the swine, as well as around the perimeter of outdoor swine feeding areas. Exterior rodent bait stations and/or traps also would have to be placed around areas of potential rodent entry into building(s) used to house and feed swine (i.e., doorways, vent openings, loading chutes, cool cells, etc.). Interior rodent bait stations and/or traps would have to 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. Interior rodent bait stations and/or traps would have to placed so that swine would not come in contact with the bait or trap. Rodent bait stations and/or traps also would need to 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 would have to 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 would have to be maintained around the perimeter of those building(s) used to house and feed swine. The sterile zone would have to be devoid of harborage or feed or water sources that could attract rodents or wildlife, but would have to contain rodent bait stations and/or rodent traps. The sterile zone also would have to 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 would require increased rodent control measures. The producer would need to provide documentation of ro