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Code · REGISTER · 2007-05-16 · Animal and Plant Health Inspection Service, USDA · Rules and Regulations

Rules and Regulations. Proposed rule

65,587 words·~298 min read·/register/2007/05/16/07-2462

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6560-50-M 72 94 Wednesday, May 16, 2007 Proposed Rules Part VI Department of Agriculture Animal and Plant Health Inspection Service 9 CFR Parts 149, 160, and 161 Trichinae Certification Program; Proposed Rule 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, 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 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 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 § 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 § 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. 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 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 § 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 § 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 § 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 § 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 § 149.3(e), a Stage II certified site must complete a site audit for Stage III certified status. Under § 149.3(e), the site audit must be performed no sooner than 240 days from the date the site was awarded Stage II certified status, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days from the date the site was awarded Stage II certified status. As further provided in § 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 § 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 § 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. 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 § 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 § 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 § 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 § 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 § 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 § 149.3 would contain more specific information on performing site audits. Proposed § 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. General Proposed § 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 § 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 § 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 § 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] Number of hours Hourly salary (FY 05) Benefits @24.26% Direct labor costs 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 whole dollar $51.00 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). 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 § 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 § 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 rodent control practices, as described above, by maintaining at the site an up-to-date rodent control logbook with a site diagram and other recordkeeping evidencing implementation of rodent control measures, which could include documents provided by a pest control operator, as provided in proposed § 149.7. Additional information relating to the rodent control logbook is provided below under the heading “Recordkeeping at Site.” • Feed or feed ingredients stored at the site would have to be prepared, maintained, and handled in a manner that protects the feed or feed ingredients from possible exposure to or contamination by rodents or wildlife. Any movable harborage in the immediate vicinity of feed production and feed storage areas that is not necessary to the day-to-day operation of the site would have to be removed. Harborage that cannot be removed or harborage that is movable but necessary to the day-to-day operation of the site ( *e.g.* , bales of hay, etc.) would have to be checked for signs of rodent or wildlife activity. Rodent bait stations and/or traps would need to be placed around (and in, if applicable) all feed preparation and storage areas, as well near any harborage in the vicinity that cannot be removed or that is movable but necessary to the day-to-day operation of the site. Rodent bait stations 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, feed or feed ingredients that are stored in paper bags would have to be elevated off the floor and be a sufficient distance away from the walls to allow for inspection, baiting, and/or trapping. The rodent control logbook, as provided in § 149.7, would have to document that adequate rodent control procedures have been implemented in the feed production and feed storage areas. • Swine could not have access to wildlife harborage or dead or live wildlife at the site. Wildlife harborage would include wood or wooded lots and other natural areas where wildlife would have access. Dead or live wildlife could not be intentionally fed to swine. • If meat-containing waste is fed to swine at the site, then the producer would have to hold a license or permit that authorizes the feeding of such waste. Cooking times and temperatures of meat-containing waste to be fed to swine would have to be consistent with applicable State and Federal laws and regulations. In addition, up-to-date records of waste feeding and cooking practices, in the form of a waste feeding logbook provided for in proposed § 149.7, would have to be maintained at the site. Cooked food waste products that are stored prior to feeding could not be mixed or contaminated with uncooked or undercooked meat waste material. Household food waste, regardless of whether it contains meat or is cooked or undercooked, also could not be fed to swine. We include this last requirement as another measure to prevent the attraction of rodents or wildlife to the site. Additional information relating to the waste feeding logbook is provided below under the heading “Recordkeeping at Site.” (The Swine Health Protection Act [SHPA, 7 U.S.C. 3801-3813] was enacted in 1980 to prevent the introduction of foreign animal diseases to U.S. domestic swine populations as a result of being fed raw or improperly treated food waste of animal origin. APHIS' regulations promulgated under the SHPA in 9 CFR part 166 require the following: Persons must have a license to feed waste materials, food waste products must undergo proper heat treatment prior to being fed to swine, facilities and animals are subject to periodic inspection, and records must be maintained with respect to the removal of all treated and untreated garbage from the licensee's premises. The Federal laws and regulations establish a minimum set of standards to be followed. States are free to set more stringent standards [which a number of States have done], including the prohibition of feeding of food waste materials to swine altogether.) • The site would need to have in place procedures that are carried out with regard to the prompt removal and proper disposal of dead swine and swine remains found in pens. We would require this practice to eliminate the opportunity for cannibalism among swine, as well as to prevent the attraction of rodents or wildlife. Such procedures would have to be documented in the animal disposal plan, as provided in proposed § 149.7. Additional information relating to the animal disposal plan is provided below under the heading “Recordkeeping at Site.” • General hygiene and sanitation of the pork production site would have to be maintained at all times to prevent the attraction of rodents and wildlife. We would require that solid non-fecal waste (facility refuse) be placed in covered receptacles and be regularly removed from the site. We also would require that spilled feed be regularly removed and properly disposed of. • All records required under proposed § 149.7 would have to be kept up-to-date and readily available for inspection at the site. Additional information relating to producer recordkeeping requirements is provided below under the heading “Recordkeeping at Site.” Initial Site Audit for Stage I Enrolled Status Proposed § 149.3(c) would cover the steps for producers seeking to enroll their pork production site in the program. Interested producers should first request and review a pre-audit information packet prepared by APHIS that discusses the program, as well as the steps in preparing for and requesting an initial site audit. The pre-audit information packet could be obtained from a QAV, State or Federal animal health offices, or the National Pork Board, or by writing to: USDA, APHIS, Veterinary Services, Trichinae Certification Program, 210 Walnut St., Room 891, Des Moines, IA 50309. When the producer and the producer's herd health personnel believe that the site meets program standards, the producer then should arrange for an initial site audit, as discussed above under proposed § 149.3(a). Upon completion of the initial site audit and submission of the completed audit form and payment, APHIS would make a determination as to program enrollment within 30 days of receipt of the audit form. A pork production site that is found to meet all good production practices and other program requirements would be awarded Stage I enrolled status. Site Audit for Stage II Certified Status Proposed § 149.3(d) would cover the steps for a Stage I enrolled site to advance in the program as a Stage II certified site. The site audit would have to be performed no sooner than 150 days (i.e., approximately 5 months) from the date the site was awarded Stage I enrolled status, and would have to be completed, with the audit form and payment submitted to APHIS, no later than 210 days (i.e., approximately 7 months) from the date the site was awarded Stage I enrolled status. APHIS would make a determination on whether to certify the site within 7 days of receiving the completed audit form and payment. We would provide this expedited review for sites seeking status as Stage II certified sites so that producers could start identifying their animals as certified swine, assuming that the Stage I enrolled site is found to meet all good production practices and other program requirements and is awarded Stage II certified status. A Stage I enrolled site that is found during a site audit not to be adhering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, would not be awarded Stage II certified status and would lose its program status as a Stage I enrolled site. Site Audit for Stage III Certified Status Proposed § 149.3(e) would cover the steps for a Stage II certified site to advance to Stage III certified site status. The site audit would have to be performed no sooner than 240 days (i.e., approximately 8 months) from the date the site was awarded Stage II certified status, and would have to be completed, with the audit form and payment submitted to APHIS, no later than 300 days (i.e., approximately 10 months) from the date the site was awarded Stage II certified status. APHIS would review the completed audit form and make a determination as to Stage III certified status within 30 days of receipt of the audit form and payment. A Stage II certified site that is found to meet all good production practices and other program requirements would be awarded Stage III certified status. If a Stage II certified site is found during a site audit not to be adhering to one or more good production practices, or fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, then the site would be subject to decertification by APHIS as provided in proposed § 149.2(e). Site Audit for Renewal of Stage III Certified Status Proposed § 149.3(f) would cover the steps for Stage III certified sites seeking to renew their program status as a Stage III site. The site audit would have to be performed no sooner than 14 months from the date the site was awarded Stage III certified status or the date that status was last renewed, and would have to be completed, with the audit form and payment submitted to APHIS, no later than 16 months from either the date the site was awarded Stage III certified status or the date that status was last renewed. APHIS would review the completed audit form and make a determination as to the site's continued status as a Stage III certified site within 30 days of receipt of the audit form and payment. A Stage III certified site that is found to meet all good production practices and other program requirements would have its status as a Stage III certified site renewed. If a Stage III certified site is found during a site audit not to be adhering to one or more good production practices, or fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, then the site would be subject to decertification by APHIS as provided in proposed § 149.2(e). Spot Audit In addition to regularly scheduled site audits, certified production sites also would be subject to spot audits. Spot audits, including random spot audit and spot audits for cause, would be covered in proposed § 149.4. The APHIS Administrator would select certified production sites at random for a spot audit in order to: • Ensure the integrity of the auditing process; • Verify that the audit process is performed in a consistent manner across the program; and • Verify that all required good production practices are being maintained between regularly scheduled site audits. A certified production site also could be subject to a spot audit for cause to trace back and investigate any positive test results based on testing of certified swine from that site at the slaughter facility. All spot audits would be performed by a QVMO at no cost to the producer. APHIS would provide the producer with written notification of the results of the spot audit, including documentation of any deficiencies noted during the audit. If the site is found not to be adhering to one or more good production practices, then the site would be subject to decertification by APHIS as provided in proposed § 149.2(e). Offsite Identification and Segregation of Certified Swine Under proposed § 149.5, certified swine moved from the certified production site to another location, whether to another certified production site, buying station, collection point, or slaughter facility, would have to remain segregated from noncertified swine at all times, and otherwise maintain their identity as certified swine in such a way that they could be readily traced back to the certified production site from which they came. Information relating to the identification of the certified swine would have to be documented in the animal movement record maintained by the producer. Failure to properly segregate or maintain the identity of certified swine from noncertified swine after leaving the certified production site would result in the loss of certified status for that shipment of swine. We would leave it up to producers or other handlers to determine how they wish to segregate the certified swine and otherwise maintain their identity as certified swine throughout the marketing process. Slaughter Facilities Proposed § 149.6 would cover the program responsibilities of participating slaughter facilities in regard to the verification, segregation, testing, and recordkeeping of swine from certified production sites. Participating slaughter facilities that fail to comply with any of the applicable requirements of § 149.6 would not be allowed to continue participating in the program and no pork or pork products will be issued a certificate of export that identifies the product as being from the Trichinae Certification Program unless all requirements of this section are followed. This would not preclude, however, FSIS from issuing an export certificate for those products if they were to be instead sent to a country that did not require certifications with respect to trichinae or if the products were subsequently frozen in order to meet an importing country's requirements in that way. FSIS would provide general oversight to verify that these functions are being carried out properly, while AMS would specifically oversee the laboratory approval and ongoing performance of laboratories that perform process-verification testing under this program. FSIS would issue instructions to slaughter facilities relating to program requirements at the time any final rule implementing the program described in this proposed rule is published. Further information with regard to laboratory approval requirements would be available from AMS as discussed under “Process-Verification Testing of Certified Swine.” Verification of Certification Proposed § 149.6(a) would require that a slaughter facility receiving certified swine verify the current certification status of the pork production site from which the animals came. The slaughter facility could verify the current certification status of individual sites by maintaining dated certification documentation on file. The current certification status of individual sites also would be available on the Trichinae Certification Program Web site on the Internet at *http://www.aphis.usda.gov/vs/trichinae.* If the slaughter facility is unable to verify a site's certification status through documentation on file or through the program Web site, the slaughter facility then should contact the APHIS area office in the State where the site is located. Maintaining Identity and Segregation of Certified Swine and Pork Products Proposed § 149.6(b) would require that in order for a slaughter facility to identify product as certified pork, the certified swine and edible pork products derived from certified swine would have to remain segregated from swine and edible pork products from noncertified sites throughout receiving, handling, and processing at the facility, as well as while awaiting shipment from the facility. The slaughter facility also would have to maintain the identity of the certified swine or pork in a manner that would allow the swine or pork to be traced back to the certified production site from which it came. A slaughter facility's failure to properly segregate or maintain the identity of certified swine and edible pork products derived from the certified swine would result in the loss of certified status for that shipment of swine, as well as the edible pork products derived from those animals. It would be up to the slaughter facility to determine how it wishes to segregate and properly maintain the identity of certified swine and edible pork products derived from certified swine in its control. It is recommended that certified swine be processed in groups either at the beginning or at the end of the day or on separate days from noncertified animals. Process-Verification Testing of Certified Swine Proposed § 149.6(c) would require slaughter facilities handling and processing certified swine from certified production sites to carry out process-verification testing at their expense in order to determine the *Trichinella spiralis* infection status of those animals. Under proposed § 149.6(c)(1), process-verification testing would have to be performed by using a validated test. This would include any test licensed by APHIS, such as those using the ELISA method, or otherwise accepted by AMS, such as the pooled sample digestion method. A copy of the testing methods and checklist for conducting validated tests would be available by contacting the Trichinae Program Manager, USDA, AMS, Science and Technology, Technical Services Branch, 1400 Independence Avenue SW., Mail Stop 0272, Washington, DC 20250-0272; or by telephone at
(202)690-0621. In proposed § 149.6(c)(2) we would require that such testing be performed in an approved laboratory that has been approved for trichinae testing by AMS. In addition to providing services relating to initial laboratory approval, AMS would monitor the ongoing performance and proficiency of laboratories that perform process-verification testing under the program. The approved laboratory could be maintained and operated by the slaughter facility or by another business entity either on the premises of the slaughter facility or at another location. We would require that the laboratory staff performing the process-verification testing be approved by AMS. Once approved, laboratory staff performing this particular testing function would be subject to periodic proficiency test panels from AMS that would have to be analyzed correctly in order to maintain their approved status. This periodic proficiency testing would be done for purposes of quality assurance. Further information on approved laboratory requirements, including any annual certification fee information, could be obtained by contacting the AMS Trichinae Program Manager. Proposed § 149.6(c)(3) would cover the requirements for process-verification testing relating to sample size and testing frequency. We would require that process-verification testing be performed in accordance with the following minimum standards relating to sample size and frequency: • Slaughter facility officials would need to determine the yearly processing capacity of the slaughter facility over the next 12 months. Officials could use the processing capacity during the past 12 months if the past 12 months were representative of a typical year. • Slaughter facility officials would have to estimate the percentage of swine processed that would likely come from certified production sites considering all swine expected to be processed during the selected 12-month period. Swine that come from certified production sites would be considered the eligible population to be sampled. • Slaughter facility officials would then need to use the Trichinae Certification Slaughter Facility Sample Size Determination Table to determine the number of samples to collect from the population of swine from certified production sites. If the eligible population is not shown in the table, the next largest number would be used to determine the number of samples to collect. Slaughter facility officials would select from the table the number of samples to collect from the column that reflects a 99 percent confidence level of detecting a positive carcass in the population. The number selected would represent the total number of samples that slaughter facility officials would have to collect and test per year and per month during the selected 12-month period. • We would require that for each sample collected, slaughter facility officials would have to maintain the identity of the sample using the TIN of the certified production site that was the source of the swine from which the sample was taken. • FSIS program employees at the slaughter facility would review and verify that an adequate number of samples have been collected and proper frequency of collection is maintained. FSIS would report this information to APHIS. • AMS representatives would verify through a laboratory approval audit that the laboratory performing process-verification testing is correctly following written procedures relating to the receipt, handling, identification, and testing of samples. These written procedures would have to be maintained by the laboratory in a quality assurance manual, as explained below under proposed § 149.6(c)(6). In addition, a laboratory that performs process-verification testing at a location other than the slaughter facility would have to include a declaration of methodology used to test samples when providing test results. • The APHIS Administrator may also, at APHIS' expense, periodically request the testing of swine brought to the slaughter facility from specific certified production sites. Requests to test swine from specific certified production sites would count towards the slaughter facility's total monthly testing requirement. Proposed § 149.6(c)(4) would cover the requirements with regard to the handling of test results. We would require that the results of process-verification testing of certified swine handled at the slaughter facility be retained in a separate file or notebook as written records at the slaughter facility and be readily available for inspection by FSIS program employees. FSIS also would report to APHIS the results of all process-verification testing. In the event of a positive test result, the slaughter facility representative would have to immediately notify the FSIS program employee designated by the FSIS Administrator, who in turn would 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. The following sequence of events would take place following a positive test result: • If a test sample is found positive based on the digestion method, then the certified production site that was the source of the swine from which the sample was taken would be decertified. • If a test sample is found positive based on an ELISA test method, and is confirmed positive by further testing using the digestion method, then the certified production site that was the source of the swine from which the sample was taken would be decertified. • If a test sample is found positive based on an ELISA test method, but is not confirmed positive by further testing using the digestion method, then the certified production site that was the source of the swine from which the sample was taken would be investigated by APHIS personnel. The investigation may include a spot audit of the affected site. Additional testing also may be performed. This investigation would determine if the production facility has sufficient safeguards and is following good production practices. While a certified production site is under investigation, the site's program status as a certified production site would be suspended. While a site is under suspension, the producer would have to continue to adhere to all good production practices and other recordkeeping and program requirements; however, swine from the suspended site could not be identified as product from a certified production site. The APHIS Administrator would determine the program status of the site within 30 days of the initiation of the suspension. A finding that risk factors are inadequately addressed in the site investigation or the finding of additional positive test results based on samples from animals or carcasses from the affected site would be grounds for APHIS decertification of the site. Proposed § 149.6(c)(5) would cover slaughter facility recordkeeping requirements relating to the handling of animals from certified production sites. We would require that all slaughter facilities that receive certified swine would have to maintain records with regard to the number of certified swine processed, the source of the certified swine, including the TIN of the certified production site from which the swine came, and all test results relating to process-verification testing. These records would have to be retained at the slaughter facility for a period of at least 3 years following the processing of such animals. Slaughter facilities handling certified swine also would need to have documented procedures on how certified swine under its control, and the edible pork products derived from certified swine, would remain segregated from swine and edible pork products from noncertified sites throughout receiving, handling, and processing at the facility, as well as while awaiting shipment from the facility. The slaughter facility also would have to have documented procedures for maintaining the identity of the certified swine or pork with respect to the certified production site from which it came. We also would require that all records and other documentation required to be maintained by the slaughter facility under proposed part 149 would have to be readily available for inspection by FSIS program employees. Proposed § 149.6(c)(6) would cover recordkeeping requirements for approved laboratories that perform process-verification testing under this program. Approved laboratories would be required to have written procedures that specify standards for sample size, sample handling, sample identification, and sample test methods used in process-verification testing. All such written procedures would have to be maintained in a laboratory quality assurance manual specifically for this program, or as a separate section of an existing laboratory quality assurance manual, and would have to be retained at the approved laboratory throughout the time the approved laboratory is performing process-verification testing under this program. All such written procedures relating to process-verification testing also would have to be readily available for inspection by FSIS program employees or AMS representatives. Proposed § 149.6(c)(7) would cover the slaughter facility overall responsibility for process-verification testing. In the event the testing is contracted to an outside approved laboratory, the slaughter facility would still retain overall responsibility that the testing is carried out as required. The slaughter facility would be responsible for obtaining testable samples and for ensuring that the correct number of testable samples are sent to the outside testing lab. Once the slaughtering facility receives those test results back from the outside testing lab, the slaughter facility would be responsible for maintaining those results in its trichinae testing records. Recordkeeping at Site Proposed § 149.7 would cover recordkeeping requirements for producers participating in the program. Under proposed § 149.7(a), Stage I enrolled sites, Stage II or Stage III certified sites, and any site that has been suspended or voluntarily decertified would have to maintain the following records: Animal disposal plan, animal movement record, feed mill quality assurance affidavit (if applicable), rodent control logbook, and waste feeding logbook (if applicable). All such records would have to be readily available for inspection at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours. Animal Disposal Plan The animal disposal plan would have to meet certain minimum requirements. Specifically, the animal disposal plan would have to: • Provide for the removal of all dead swine or swine remains from swine pens immediately upon detection. Inspections for purposes of detecting dead animals would have to occur at least once every 24 hours. • Specify how often and at what intervals the swine pens are observed each day. • Provide for the proper storage of dead swine or swine remains in accordance with local, State, and Federal laws and regulations. If the carcass storage facility or composting facility is located on the site, then the animal disposal plan would have to provide for a storage or composting facility that precludes rodent or wildlife contact with dead swine or swine remains being stored or composted. • Provide for the disposal of swine and other mammals by rendering, incineration, composting, burial, or other means, as allowed by and in accordance with local, State, and Federal laws and regulations. For sites that use rendering services, the animal disposal plan also would have to include the name, address, and phone number of the renderer. • Be updated as animal disposal practices are changed at the site. • Be signed and dated by the producer as well as the caretaker of the site (if the caretaker is a different person than the producer). • Be valid for a period no longer than 2 years after the date of signature by the producer and (if applicable) the site caretaker. Animal Movement Record The animal movement record would have to meet certain minimum requirements. Specifically, the animal movement record would have to: • Be filled out completely and properly, accounting for the movement of all non-breeding swine into and from the pork production site. • In the case of non-breeding swine coming into the site, include the date and number of arriving animals, as well as the TIN of the certified production site where the animals originated, or alternatively, if the swine are less than 5 weeks of age and originated from a noncertified site, the name and full address of the noncertified site where the animals originated. The animal movement record would have to clearly document that all non-breeding swine 5 weeks of age or older that arrive at the site originated from another certified production site. • In the case of non-breeding swine leaving the site, include the date and number of departing animals, and their destination. • Document the number of dead non-breeding swine that are removed from the site, as well as the number of dead non-breeding swine that are buried or composted at the site, if swine burial or composting is permitted in that State or locality. All entries to the animal movement record would have to be signed or initialed, as well as dated, by the producer or other site caretaker making the entry. We would take into account that pork production sites seeking Stage I enrolled status may have limited documentation regarding these activities. However, we would still require that such sites have initiated documentation that addresses these matters. The 180-day enrollment period would provide Stage I sites further opportunity to develop their recordkeeping. Rodent Control Logbook The rodent control logbook, which may include records from a pest control operator, would have to meet certain minimum requirements. Specifically, the rodent control logbook would have to: • Include a rodent control diagram for the site indicating the location of all rodent bait stations and rodent traps at the site. The diagram would have to be updated whenever bait stations are added, moved, or removed. • Document the number of rodent traps set (if applicable), the number of new rodent bait stations set, and how often bait is refreshed. • Document the disposal method for all unused bait that is replaced. • Document the brand name and active ingredient of bait, which would have to be EPA registered and applied according to its label, as well as the quantity of bait used (number of pounds). • If possible, document the number of rodents caught or killed and indicate whether they are mice or rats. • If possible, document the number of rats sighted monthly. All entries to the rodent control logbook would have to be signed or initialed, as well as dated, by the producer or other site caretaker making the entry. It would have to be updated at least monthly. Feed Mill Quality Assurance Affidavit The feed mill quality assurance affidavit, to be used in conjunction with feed or feed ingredients delivered to the pork production site, would have to meet certain minimum requirements. Specifically, the feed mill quality assurance affidavit would have to: • Include the name of the producer and the identity of the site, including the TIN if it has been issued, and the site address, as well as the name and address of the feed mill and the name and title of the feed mill representative. • Provide that the feed mill is following good manufacturing practices, and further specify, as evidence of these good manufacturing practices, the following: That the feed mill has a rodent control system that is maintained by the feed mill itself or by a pest control firm (include name and address of pest control firm); The frequency with which such rodent control system is maintained ( *i.e.* , on a weekly basis, etc.); and That the feed mill maintains records of pest management practices or has records generated by a pest control operator, which would have to be made available to the producer upon request. • Be signed by the feed mill representative and by the producer or the producer's designated representative, and would remain in effect for a period of 2 years. Waste Feeding Logbook If the producer feeds meat-containing food waste to swine at the site, the producer would have to maintain a waste feeding logbook that meets certain minimum requirements. Specifically, the waste feeding logbook would have to: • Include the name of the producer and the identity of the site, including the TIN if it has been issued, the site address, and the number of the license or permit authorizing the feeding of such waste to swine. • Be kept up-to-date with documentation evidencing adherence to applicable State and Federal food waste feeding laws and regulations. • Provide information as to the method used in cooking the meat-containing food waste. • For each batch of meat-containing food waste cooked, record the batch number (if applicable to the operation), the temperature at which such food waste is cooked and the length of time it is held at that temperature, and the method for verifying the temperature and length of time cooked. • For each batch of meat-containing food waste cooked, document the sources of meat. • Evaluate and document on at least a monthly basis the level of sanitation of the site, taking into account the following factors: Whether garbage containers are clean and covered with lids; Sanitation of cooking area and equipment; Sanitation of feeding areas and waste disposal; Sanitation of storage areas; Rodent control system around equipment, storage, and feeding areas; Sanitation of waste hauling trucks or containers; Access of other animal species to food waste (wild animals, dogs, cats, etc.); and The potential for cross-contamination between cooked product and raw meat-containing food waste. All entries to the waste feeding logbook would have to be signed or initialed, as well as dated, by the producer or other site caretaker making the entry. Under proposed § 149.7(b), we would require that all required records and other documentation to be maintained by producers in the program would have to be kept at the pork production site for a period of 2 years. In addition, under proposed § 149.7(c), we would require that these records be readily available for inspection at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours. Program Fees and Charges Proposed § 149.8 would address the subject of program fees and charges. 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 have to 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. Further, if the QVMO who performs the site audit is employed by APHIS, then the producer would have to pay APHIS for this service at a prescribed hourly rate as set forth in proposed § 149.8. We are proposing that the rates for the services of an APHIS-employed QVMO would be $84 per hour and $21 per quarter hour, with a minimum charge of $25 per service. If an APHIS-employed QVMO performs the site audit outside his or her normal tour of duty, then the rates would increase to $100 per hour and $25 per quarter hour for Monday through Saturday and holidays and $112 per hour and $28 per quarter hour for Sundays. These proposed rates are comparable to current rates charged for other veterinary services conducted by APHIS employees, and are designed to recover the cost incurred by APHIS in providing these services. Payment to APHIS for the services of an APHIS-employed QVMO would have to be in the form of a certified check or U.S. money order and would have to be remitted to the QVMO at the time the service is provided. In addition to the cost of the site audit, proposed § 149.8 would provide that the producer also would have to pay APHIS a program fee at the time of each site audit in the amount of $51 to cover APHIS' administrative costs in processing the audit and operating the program. This program fee, payable to APHIS by certified check or U.S. money order, would be due at the time of submitting the completed site audit form for APHIS evaluation. This program fee would not be subject to refund, regardless of the results of the site audit or other determination as to the producer's program status. Finally, proposed § 149.8 provides that a producer would not be charged for the cost of having a spot audit performed at the pork production site. Pilot Program Sites In proposed § 149.9, pork production sites that are participating in an APHIS-approved trichinae pilot program at the time the final rule for establishing the Trichinae Certification Program becomes effective would maintain their same program status as either a Stage I enrolled, Stage II certified, or Stage III certified site, as well as their same program anniversary date for purposes of completing future site audits and submitting completed audit forms and payment. We are proposing this provision to recognize those producers that volunteered to participate in our pilot program and invested their time and effort, as well as the expenditure of money to upgrade their sites, in order to be in compliance with good production practices and other pilot program requirements. Changes to 9 CFR Part 160 Section 160.1 of the regulations in 9 CFR part 160 contains definitions for terms appearing in parts 160 through 162 on accreditation of veterinarians. We are proposing to add a new definition to § 160.1 for the term *qualified accredited veterinarian* or *QAV* , which we would define as an accredited veterinarian who has been granted an accreditation specialization by the APHIS Administrator pursuant to § 161.5 of our regulations based on completion of an APHIS-approved orientation or training program. We would make this change in conjunction with another proposed change to part 161, as discussed below. Changes to 9 CFR Part 161 The regulations in 9 CFR part 161 contain the requirements and standards for accredited veterinarians and suspension or revocation of such accreditation. We are proposing to add a new § 161.5 on specializations for accredited veterinarians. Under proposed § 161.5, an accreditation specialization recognized by the APHIS Administrator may be granted to an accredited veterinarian upon completion of an orientation or training program approved by APHIS. An accredited veterinarian who is granted such a specialization would be referred to as a qualified accredited veterinarian or QAV. For certain accredited specializations, the cost of orientation or training would be borne by the accredited veterinarian. QAVs would be authorized to perform those activities and functions specifically provided for elsewhere in chapter I of 9 CFR. Additional information on accreditation specializations, including training requirements and fees, could be obtained by contacting the National Veterinary Accreditation Program, VS, APHIS, 4700 River Road Unit 46, Riverdale MD 20737,
(301)734-6188. Under proposed § 161.5, the Administrator of APHIS would grant the status of qualified accredited veterinarian or QAV to those accredited veterinarians who complete an APHIS-approved orientation or training program covering that particular specialization. Therefore, an accredited veterinarian who completes the APHIS-approved training in good production practices in swine management could become a QAV, and then be authorized to perform site audits and other specified program services under the Trichinae Certification Program in part 149. Executive Order 12866 and Regulatory Flexibility Act This proposed 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. For this proposed rule, we have prepared an economic analysis. The economic analysis, which is set out below, provides a cost-benefit analysis as required by Executive Order 12866 and an analysis of the potential economic effects of this proposed rule on small entities as required by the Regulatory Flexibility Act. We currently do not have all of the data necessary for a comprehensive analysis of the effects of this proposed rule on small entities. Therefore, in accordance with 5 U.S.C. 603, we have prepared an initial regulatory flexibility analysis. We are inviting comments about potential effects of this proposed rule on small entities. In particular, we are interested in determining the number and kinds of small entities that may incur benefits or costs from the implementation of this proposed rule, and the economic effects of those benefits or costs. In accordance with the Animal Health Protection Act (7 U.S.C. 8301-8317), 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 tribe authorities, or other persons in the administration of regulations for the improvement of livestock and livestock products. In accordance with 21 U.S.C. 601 *et seq.* , the Secretary of Agriculture is authorized to inspect meat and meat products at any slaughtering, packing, meat-canning, rendering, or similar establishment, while under 21 U.S.C. 451 *et seq.* , the Secretary of Agriculture is authorized to inspect poultry and poultry products at official establishments. Finally, in accordance with 7 U.S.C. 1621 through 1627, the Secretary of Agriculture is authorized to provide a range of voluntary inspection, certification, and identification services to assist in the orderly marketing of various animal products and byproducts. Based upon available data and expected effects, we believe that some producers and facilities may come to the conclusion that the benefits of the proposed program, in terms of increased exports and lower costs to meet the requirements of importing countries, would justify the costs of their participation. Costs for Participating Producers According to USDA's National Agricultural Statistics Service (NASS), there were an estimated 75,350 hog and pig producers in the United States in 2002 [see NASS Agricultural Statistics, 2003 (Table 7-26)]. This was down from 80,880 producers in 2001. Since 2002, the number of producers has declined even further with 67,330 operations reported in 2005. Although the structure of the industry has changed over time, the number of hogs as well as consumption of pork has remained relatively constant over the same period. The number of producers who would participate in the certification program is not known. Participation by producers would depend primarily on economic and other market competitiveness considerations. Participation will be based on how much of the producers' pork would enter into export markets that have trichinae requirements. We believe that most producers, especially the larger ones, are likely to participate in the program. This is because they have already implemented and routinely follow many of the proposed good production practices required for certification. Industry experts have estimated that 90 to 95 percent of commercial pork production sites in the United States could meet the proposed program requirements for site certification with, at most, only minimal facility changes (i.e., those costing approximately $500 over a 5-year period, equivalent to a present value of about $440 when discounted at 7 percent). However, recent experience with the pilot program has shown that while 90 to 95 percent of these sites could meet the requirements with only minimal changes, it is likely that only 40 to 50 percent would actually choose to participate. In general, larger producers have more mitigations in place so they are more readily able to participate. Small producers could participate in the program as well as long as they are able to meet program risk mitigations. At worst, only moderate facility changes (i.e., those that cost $2,500 over 5 years) would likely be required. The estimated cost of $2,500 for moderate facility changes consists of $1,500 in first year startup costs and maintenance costs of $250 per year for the next 4 years. (For further information, see Cummings, David and Kopral, Christine, “Cost Analysis of Trichinae-Free Program Alternatives,” USDA, APHIS, Centers for Epidemiology and Animal Health, December 1998, referred to below as the CEAH analysis. Copies of the CEAH analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT ). Producers seeking to participate in the program would be required to pay the veterinarians' audit fees to perform both the initial and subsequent site audits. These fees are estimated at about $150 per audit. After the first three audits are completed over a 15-month period at a cost of $450, certified production sites would be subject to audits only once every 15 months. In addition to the cost of the site audit, the producer would be responsible for paying a separate program fee to APHIS at the time of each site audit. This program fee would cover APHIS' administrative costs in processing the audit and operating the program. As proposed, the program fee would be $51. Also, producers may have to pay for the postmortem blood, tissue, or meat juice sample tests if the cost of these tests is passed on to them by the slaughter facilities. Based on the information presented in the preceding paragraphs, we have prepared the following table summarizing the estimated costs of participating in the program over 5 years: Table 2.—Estimated Costs for Participating Producers Year 1 2 3 4 5 Estimated site audit fees $300 $150 $150 $150 $150 Program fees 102 51 51 51 51 Subtotal 1 402 2 201 3 201 3 201 3 201 Facility improvement costs: 4 Minimal 100 100 100 100 100 Moderate 1,500 250 250 250 250 Yearly total $502 to $1,902 year 1; $301 to $451 each year, years 2 to 5. 5-year total $1,706 to $3,706 over 5 years. 1 Assumes site audit and program fees for attaining both Stage I Enrolled and Stage II Certified status during year 1. 2 Site audit and program fees for moving from Stage II to Stage III Certified status. 3 Site audit and program fees for renewal of Stage III Certified status. 4 Experience with the pilot program has shown that 90 to 95 percent of sites could meet program requirements with only minimal facility improvements, so only 5 to 10 percent of sites might have to incur the moderate facility improvement costs. For producers that decide to participate in the program, a potential downside is the possibility that swine from their sites could test positive for trichinae at slaughter, resulting in a loss of program status as a certified site. Once a site is decertified, swine from that site could not be identified as 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 audit for Stage I enrolled status. It is reasonable to assume that most producers who decide not to participate in this program would be small in size, although there are some small producers that would also need to make only minimal changes to satisfy program requirements. Costs for Participating Slaughter Facilities The number of slaughter facilities that may wish to process certified swine and export their meat as produced under the Trichinae Certification Program is uncertain. As with producers, participation would depend on economic competitiveness considerations. Certain countries that import pork require testing for trichinae. Therefore, any facility that wants to export pork must meet these testing requirements. Slaughter facilities would have to determine whether it would be better to continue to follow their traditional trichinae testing protocols, or whether sourcing animals from certified producers while observing the program requirements for slaughter facilities would provide them an economic incentive. Slaughter facilities that purchase swine from certified production sites would be required to carry out certain functions relating to verification, segregation, testing, and recordkeeping of certified swine under its control. Testing at the slaughter facility would entail taking tissue, blood, or meat juice specimens from a sample of the certified swine population processed at the facility in order to determine the *Trichinella spiralis* infection status of the tested animals and to verify that the trichinae management practices at the production level are adequate. The number of required test samples would vary among individual facilities, depending on the total number of animals from certified production sites that are slaughtered. The testing requirements are designed to produce a 99 percent confidence level of detecting a positive carcass in the population based on a prevalence of 0.013 percent. For example, a plant that slaughters 1 million certified swine per year would be required to run 34,802 tests annually, but a plant that slaughters 5,000 certified swine per year would need to run 4,996 tests each year. Slaughter facilities could conduct sample testing using either an ELISA or a pooled diaphragm test and would have the option of processing the test samples themselves at the slaughter facility or sending it to an offsite commercial laboratory. On-site processing of test samples should result in lower costs per test once the necessary testing equipment is in place. In this regard, it is anticipated that many slaughter facilities, especially the large and medium ones, would acquire ELISA test readers, regardless of whether they participate in the certification program, due to FSIS' HACCP inspection procedures and because of the public's demand for food safety and quality. ELISA test readers cost about $5,000 each, while pooled diaphragm digestion test readers cost $2,900. An ELISA test costs approximately $0.83 per swine using the services of a commercial laboratory, and up to $0.66 per swine if processed by the slaughter facility itself. By comparison, a digestion test costs approximately $1.72 per swine if processed by a commercial laboratory, and $0.92 per swine if processed by the slaughter facility. 3 3 These figures are from the CEAH analysis. It is important that because the CEAH study was published in 1998, the findings are somewhat dated Throughout this analysis, the data used in the CEAH analysis have been updated where possible in order to obtain a more current estimate of the cost. An ELISA test, therefore, is less costly than a digestion test. However, if an ELISA test is used and the results are positive, then those findings would have to be confirmed by using a digestion test. For a large slaughter facility required to run 34,802 tests each year, the ELISA test would cost $28,886 annually if processed by a commercial laboratory and $22,969 if processed by the slaughter facility itself, and the digestion test would cost $59,859 annually if processed by a commercial laboratory and $32,018 if processed by the slaughter facility itself. For a small plant required to run 4,996 tests each year, the ELISA test would cost $4,147 annually off site and $3,297 annually on site, and the digestion test would cost $8,593 annually off site and $4,596 annually on site. As discussed above, the number of slaughter facilities that would participate in the program by purchasing swine from certified production sites is uncertain. If slaughter facilities do wish to accept certified swine and identify pork as produced under the Trichinae Certification Program, it is not known whether they would absorb all the testing costs or pass on some of those costs to producers or consumers. Slaughter facilities may experience negative effects from this proposed rule in the event of a trichinae positive test. Given the rarity of trichinae in swine currently, the likelihood of a positive test from an animal that comes from a certified production site would be small. However, if there was a positive test result, presumably there would be some cost to the slaughter facility since it could lose a source of certified animals if the site is decertified. The total cost to the slaughter facility in the event of a positive test is uncertain at this time. Costs for Participating Accredited Veterinarians The proposed rule would provide accredited veterinarians who are qualified to conduct site audits under the program with another source of revenue. To become qualified, accredited veterinarians would need to complete an APHIS-approved orientation or training program in good production practices in swine management. At least initially, APHIS would provide this special training to accredited veterinarians itself, charging them an amount sufficient to recover the Agency's costs, estimated at $50 per trainee. QAVs would need requalification training, but this would not occur more than once every 2 years, and the accredited veterinarians would be charged the same $50 fee. Currently, veterinarians do not have to pay a fee or receive periodic training to maintain accreditation status. However, for certain accredited specializations, such as conducting site audits under the trichinae certification program, we are proposing that the accredited veterinarian would be responsible for the cost of orientation and periodic training to perform this activity. The special training would not be mandatory for accredited veterinarians, so any training costs would be voluntarily assumed. For those accredited veterinarians who do opt for the training in order to perform site audits for producers, the cost of the training would be offset by income in the form of fees received from producers for site audits. Impact on Federal Agencies Unlike traditional disease eradication programs, herd certification programs are indefinite, and exist for as long as the producer wishes to maintain certification status. Due to the changes in the meat inspection process that have occurred at the slaughter and processing level, increasingly, packers will require various forms of food security certifications as criteria for producers that wish to sell their product to them. In fiscal year
(FY)2007, trichinae certification activities would shift from being in the pilot phase to the early national program roll out phase, assuming this proposed rule is implemented. In late FY 2007 or early FY 2008, the trichinae certification program would become a national program, available in increasing numbers of States and involving potentially thousands of herds. Initial national program emphasis would be placed on 5 of the 17 major swine producing States that account for approximately 94 percent of the Nation's total swine production, but the program would be made available to all who volunteer to participate. Successful implementation of the trichinae certification program would require integration of APHIS on-farm activities with AMS and FSIS plant and processing actions to ensure the safety and quality of animal derived food products. The impacts on AMS and FSIS are expected to be minimal. AMS representatives would certify laboratories with respect to trichinae testing, and FSIS program employees would check records in plants to ensure compliance with testing and recordkeeping requirements, as well as provide general oversight that plants are carrying out other program responsibilities properly. The personnel and time requirements for AMS and FSIS to meet their obligations are not expected to be significant. Export Benefits Associated with the Program The proposed program is designed to increase sales and marketability of fresh pork products destined for foreign markets, which would benefit participating swine producers and slaughter facilities. The United States is a net exporter of pork and has been the second largest exporter of pork, trailing the European Union (EU), in recent years. Other major exporters include Canada and Brazil. Japan, Mexico, and Canada are the primary markets for U.S. pork exports. The United States also exports pork to Russia and the EU, but these averaged less than 5 percent of total exports over the 2000 to 2005 period. Additionally, the United States is a net importer of pork in trade with the EU, with exports to the EU declining from 2001 to 2005. Although not certain, a voluntary trichinae certification program could increase opportunities for participating producers and slaughter facilities to export to countries that monitor for Trichinella spiralis in pork. How much this program would increase U.S. pork exports is not known. U.S. pork exports have been increasing for the past decade and are expected to continue to increase. Approximately 9 percent of U.S. pork production is exported. Given the steady per capita domestic consumption over the past decade, if U.S. pork production is to continue to grow, the growth likely will be driven by export demand. A voluntary trichinae certification program is one step in keeping U.S. producers competitive in the world market. According to Canadian animal health personnel, maintaining trichinae free status for most of Canada has been instrumental in facilitating the country's $1 billion annual export market for pork ($410 million in fresh cuts), as well as in maintaining its annual per capita consumption of pork totaling 28 kg (H. Ray Gamble, Trichinae Fact Sheet, *http://www.aphis.usda.gov/vs/trichinae/* ). However, it should be noted that the majority of Canadian exports of pork go to the United States and Mexico, neither of which have trichinae-specific entry requirements for imported pork. So while it may be helpful, it is not certain that the proposed voluntary trichinae certification program would automatically lead directly to increased exports of pork and pork products. The EU and Russia have traditionally been markets where the United States has not had a large presence. It is the industry's hope that the certification program would open these markets to more pork from the United States. The United States recently signed an agreement with the Russian Federation that would allow pork into Russia either after being tested for trichinae or frozen. Before now, Russia required both in order to be permitted into the country. Additionally, Brazil has historically been Russia's largest supplier of pork. However, outbreaks of foot-and-mouth disease in the latter part of 2005 hampered Brazil's ability to supply that market. Thus, other exporters, including the United States, are looking to capitalize on this opportunity to gain market share in the Russian pork market. The voluntary certification program could potentially lead to increased exports to countries that require trichinae testing, such as the European Union. The U.S. Meat Export Federation (USMEF) believes U.S. exports to the EU would increase with the certification of new EU-approved plants and reduction in costs associated with trichinae testing. The weak dollar will also help the cause of U.S. exports. Increases in exports may not be immediate since there are currently only three EU-approved plants that are not able to fill the U.S. quota. Furthermore, the USMEF sees a potential for growth in the processed pork products market, i.e., fully cooked bacon, rather than the fresh, chilled, and frozen sector. Currently, domestic exporters face a duty free quota of 45,000 metric tons of pork to the EU. In 2005, the United States sent approximately 6,600 metric tons of pork to the EU, which accounted for 0.7 percent of total U.S. exports. If exports to the EU were to increase by 16,000 metric tons over those reported in 2005 as expected by the National Pork Producers Council (NPPC), the EU share of U.S. exports would increase to approximately 2.5 percent. Additionally, the NPPC estimates that an increase of this magnitude would increase the value of exports by $60 million. This represents a threefold increase in the 2005 value of exports to the EU, or a 3.4 percent share of the total $2.3 billion pork export market. However, based on historical unit values for U.S. exports of pork to the EU and the world and the estimated increase in exports to the EU, the value increase predicted by the NPPC appears to be overly optimistic. Additionally, based on the expert opinion of pork analysts at USDA's Economic Research Service, it is unlikely that the voluntary certification program would change the European Union's mix of pork imports. Testing costs under the voluntary certification program outweigh the costs of testing and freezing under the current regime. This is a result of the fact that the United States does not export large amounts of pork to countries having mandatory testing and freezing requirements. In fact, the average costs of testing and freezing per pig slaughtered are $0.02, 4 compared to $0.15 in the lowest cost scenario under the voluntary certification program. This cost comparison assumes the same slaughter numbers in both cases, and a 50 percent participation rate in the trichinae certification program. However, there may be certain producers that would benefit since APHIS is not able to look at each producer individually and must average results across all producers. APHIS welcomes any comments the public may have on the potential cost savings related to testing and freezing. 4 Testing costs are derived from the 1998 CEAH study and have been adjusted for inflation. Freezing costs were obtained from Dave Pyburn, the APHIS National Trichinae Coordinator. Cost-Benefit Summary As discussed, producers, slaughter facilities, and accredited veterinarians would be subject to certain costs if they chose to participate in the trichinae certification program. Producers would likely incur added expenses to ensure that their sites meet good production practices. Similarly, slaughter facilities that choose to receive certified swine for processing also would likely incur additional costs in following program requirements, including the testing of certified swine processed at the facility in order to verify that the good production practices at the production level are adequate. Accredited veterinarians who wish to perform site audits would have to pay the cost of the training that would be necessary before performing this service for producers. The program itself would not impose additional costs on U.S. consumers, although some slaughter facilities may pass on a portion of their costs to consumers. As indicated in the CEAH analysis, a voluntary certification program involving periodic testing at slaughter would be less expensive than a program that would involve mandatory national testing. Also, because the program is voluntary, producers who judge the costs to exceed the benefits for their individual operation could opt not to participate in the program. We expect that costs incurred by producers, slaughter facilities, and accredited veterinarians in choosing to participate in the voluntary program would be justified in the long term by the program's export and food safety benefits. Producers and slaughter facilities should benefit from increased export opportunities that develop as a result of the increased availability of certified pork products, while accredited veterinarians participating in the program would have a potential source of additional income. Alternatives to the Proposed Rule In considering alternatives to the proposed rule, we looked to the findings of the CEAH analysis of Trichinae Certification Program alternatives. The CEAH analysis compared the costs of two alternative methods for achieving Trichinae Certification Program status in U.S. swine: An evolving on-farm certification program ( *i.e.* , voluntary program) that involves periodic testing at the slaughter facility versus a national carcass testing program by the pooled sample digestion method ( *i.e.* , mandatory program). Part I of the CEAH analysis describes inputs, assumptions, and projected costs for an evolving on-farm certification alternative. Part II describes inputs, assumptions, and projected costs for a national carcass testing program using the digestion method. Bottom-line results of this analysis are expressed as average annual cost per pig over 5 years. It is important to note that where possible, the data in the CEAH study have been updated through 2002 in order to obtain better estimates of the cost of a voluntary certification program versus a mandatory program. Where recent data were not available, data from the 1998 study was used and adjusted for inflation in years 2 through 5. Although startup and maintenance costs for on-farm certification were averaged over 5 years, actual spending by producers may be higher in the first year and lower in years 2 through 5 of each 5-year period. In the CEAH analysis, one component of proposed on-farm certification is periodic ELISA testing at slaughter. Projected costs for on-farm certification were calculated in Part I under options in which
(1)large and medium slaughter facilities do required ELISA testing monthly and
(2)large and medium slaughter facilities do ELISA testing quarterly. It was assumed that small slaughter facilities could only accomplish the required ELISA testing quarterly. Voluntary Certification Program In projecting costs for on-farm certification using ELISA testing, the most influential variables were the percentage of U.S. producers that would incur zero, minimal, or moderate costs to establish and maintain good production practices
(GPP)sufficient for on-farm certification, and how much these costs would be. Regarding the percentages of sites that would incur costs, it was necessary to consider a range of scenarios because data, experiences, and perceptions varied significantly. The three GPP scenarios appear in table 3 below. Regarding the dollar amounts of those costs, minimal startup and maintenance costs were estimated to be $500 over 5 years, and moderate costs to be $2,500 over 5 years. Table 3.—Average Annual Cost per Pig Under On-Farm Certification Percentage of sites that would incur no additional costs, minimal GPP costs, or moderate GPP costs Average annual cost per pig over 5 years
(a)Based on monthly ELISA testing at large/medium facilities: Scenario 1: 90, 5, 5 $0.148 Scenario 2: 36, 32, 32 0.225 Scenario 3: 4, 48, 48 0.271
(b)Based on quarterly ELISA testing at large/medium facilities: Scenario 1: 90, 5, 5 0.142 Scenario 2: 36, 32, 32 0.219 Scenario 3: 4, 48, 48 0.265 Mandatory Certification Program The alternative program, national carcass testing by the digestion method as described in Part II of the CEAH analysis, would entail testing every carcass at slaughter. Under this option, USDA would require swine producers to participate in a trichinae certification program. The CEAH analysis assumes that 95 percent of all sites would be certified under a mandatory program. Sites that are not certified would have to have their swine undergo testing by the digestion method at slaughter. The producers of these non-certified animals would assume the cost of testing. It is assumed that larger facilities would use their own laboratories for testing, and smaller facilities would send their samples to independent laboratories for testing. All laboratories would be monitored by AMS. Average annual cost per pig under national carcass testing by the digestion method was calculated to be $0.854, which significantly exceeded the highest cost scenario for an on-farm certification program. Would the additional benefits of a mandatory program outweigh the costs? The CEAH analysis shows that a voluntary certification program involving periodic testing at slaughter is less expensive than under a national carcass testing program using the digestion method. While there are no cost estimates for producers who choose not to participate in a voluntary program, it is reasonable to assume that they choose not to participate based on some benefit-cost calculation, either formal or informal (i.e., costs of participating outweigh the benefits). The CEAH analysis assumes that most of the sites that would not participate in a voluntary program would involve producers with fewer than 100 head of swine. These producers would qualify as small businesses under the Small Business Administration
(SBA)criteria, under which producers with not more than $750,000 in annual receipts are considered small businesses. Imposing a mandatory certification program could place an undue burden on swine producers considered to be small businesses. Maintain Status Quo Under this option, USDA would not establish a voluntary trichinae certification program. Producers and consumers would forgo benefits associated with the program and any potential benefits from increased exports and improved food safety would not be realized. Producers exporting to countries that monitor for *Trichinella spiralis* in pork would have to continue to test individual animals. The savings that could be realized from a voluntary certification program that would require testing only a sample of animals would not be captured. Initial Regulatory Flexibility Analysis The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small business, small organizations and small governmental jurisdictions. Section 603 of the Act requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis
(IRFA)that describes expected impacts of a proposed rule on small entities. Section 603(b) of the Act specifies that an IRFA shall contain: • A description of the reasons why action by the agency is being considered; • A succinct statement of the objectives of, and legal basis for, the proposed rule; • A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply; • A description of the projected reporting, recordkeeping and other compliance requirements of the proposed rule including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; • An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap or conflict with the proposed rule; • A description of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities. Reasons for the Action APHIS is proposing a voluntary trichinae certification program. Currently, any pork going into the European Union and Russia, along with a few other countries, must be tested and found free of *Trichinella spiralis* . Additionally, the meat must be frozen before shipment. Under the proposed voluntary program, producers could choose to certify a production site rather than undergo testing of each carcass at the slaughter facility that is destined for certain markets. Due to favorable changes in Europe regarding the certification of slaughter facilities in the United States, industry participants feel a certification program like the one proposed here could help domestic producers obtain a larger share of the EU market, as well as open that market to the exportation of fresh chilled, rather than frozen, products. Additional market forces, combined with the effects of this voluntary program, may also open the Russian market to additional imports of U.S. pork. Objectives and Legal Basis The objective of the rule is to give producers the ability to certify a production site rather than testing each individual carcass destined for markets that require trichinae testing, specifically the EU and Russia. The certification program presented here would be strictly voluntary, thus APHIS would not require producers to undergo certification. The program is based on APHIS' authority under the Animal Health Protection Act. Small Entities That May Be Affected The proposed rule, if implemented, would have potential implications for swine producers and slaughter facilities both in terms of the costs they might incur to satisfy program requirements and in terms of the benefits associated with any increase in fresh pork sales as a result of the program's establishment. For both producers and slaughter facilities, the majority of establishments that we expect to take part in the program are small entities (not more than $750,000 in annual receipts for producers and 500 employees for slaughter facilities). Over 80 percent of U.S. swine producers and 95 percent of slaughter facilities are small businesses according to these SBA guidelines. Participation of producers in the trichinae certification program would be voluntary. Small operations could decide not to participate in the program if they believe the costs of maintaining certified status outweigh the benefits of producing certified swine. Slaughter facilities would also face this decision. Because participation is voluntary, the proposed rule is not expected to have an adverse impact on small businesses. Reporting, Recordkeeping, and Other Compliance Requirements Producers would have to pay for a site audit by the accredited veterinarian, program fees for certification from APHIS, and possibly testing. Slaughter facilities that purchase swine from certified production sites would be required to carry out certain functions relating to verification, segregation, testing, and recordkeeping of certified swine under its control. Thus, the slaughter facility would have to keep records of the number of animals slaughtered from certified sites. They would also have to make sure that certified and non-certified animals were kept separate throughout the whole process. These facilities would also be responsible for keeping records related to testing. In the end, however, it is a voluntary program, so participants only take on this burden if they feel the program would benefit them. Duplicating, Overlapping, or Conflicting Federal Rules APHIS has not identified any duplication, overlap, or conflict of the proposed rule with other Federal rules. Economic Impact on Small Entities The Agency does not expect the proposed rule to result in significant economic impacts on small entities, and has therefore not set forth alternatives to minimize such impacts. Participation of producers in the Trichinae Certification Program would be voluntary. Small operations could opt to not join or withdraw from the program if they found the costs of maintaining certified status outweigh the benefits of producing certified swine. Because it is voluntary, the proposed rule is not expected to have an adverse impact on small businesses. Summary of Initial Regulatory Flexibility Analysis The proposed rule would establish a voluntary trichinae certification program. Producers who wish to participate would have to pay for an audit by an accredited veterinarian of their site. Additionally, they may incur the costs of carcass testing if the slaughter facility conducting the testing passes that cost to the producer. However, since this is a purely voluntary program, producers may opt not to incur any of these expenses. Individuals in the pork industry are hopeful this certification program would help domestic producers gain market share in countries that require trichinae testing, particularly the EU and Russia. The EU is reducing the certification requirements for slaughter facilities, and industry participants feel the voluntary certification program would substitute for the mandatory testing of all carcasses destined for that market. The benefits of the rule lie in its potential to open markets requiring mandatory trichinae testing to additional domestic product. However, the extent to which these markets would open is unknown. Costs under the certification program appear to be higher than current testing costs due to the fact that a small amount of product is currently sent to the EU and Russia. However, certain producers may find it to their advantage to participate given their particular situation. Since the program is voluntary and does not impose any costs on producers not wishing to participate, small entities would not be negatively impacted by this proposed rule. In the end, producers will participate in the program if they feel the benefits garnered from the certification program will outweigh the costs they incur. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted:
(1)All State and local laws and regulations that are in conflict with this rule will be preempted;
(2)no retroactive effect will be given to this rule; and
(3)administrative proceedings will not be required before parties may file suit in court challenging this rule. National Environmental Policy Act An environmental assessment has been prepared for this proposed rule. The assessment provides a basis for the conclusion that the implementation of the Trichinae Certification Program, as provided for in the proposed rule, would preclude any potential adverse effects on endangered and threatened species and their habitats, and would not have a significant impact on the quality of the human environment. The environmental assessment has been prepared in accordance with:
(1)The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 *et seq.* ),
(2)regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508),
(3)USDA regulations implementing NEPA (7 CFR part 1b), and
(4)APHIS' NEPA Implementing Procedures (7 CFR part 372). The environmental assessment may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT . Comments on the environmental assessment may be submitted using the methods described under ADDRESSES . Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2006-0089. Please send a copy of your comments to:
(1)Docket No. APHIS-2006-0089, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238, and
(2)Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule. The proposed Trichinae Certification Program is a voluntary program to certify pork as produced under good production practices that reduce, eliminate, or avoid the animal's risk of exposure to *Trichinella spiralis* infection risk factors. *Trichinella spiralis* or trichinae is a parasitic disease of warm-blooded carnivores and omnivores, including swine. Uniform program standards have been developed by organizations representing the pork industry, State animal health agencies, and USDA. These standards provide the guidelines for implementing the requirements for this voluntary program. In this program, pork production sites would be audited by USDA trained and accredited veterinarians. During the site audit, the veterinarian would observe and collect information about the site, including swine sources, feed sources, rodent and wildlife control, and facility hygiene. This information would be collected on USDA-approved official program audit forms. APHIS would review the information obtained from the site audit to ensure that the required program standards relating to good production practices are in place and being maintained at the site in order to reduce, eliminate, or avoid the risk of exposure of swine to trichinae. APHIS would maintain a database containing records for each pork production site participating in the program. Listings of certified production sites by TIN and program status would be posted on the Trichinae Certification Program Web site at *http://www.aphis.usda.gov/vs/trichinae* and would be accessible to APHIS personnel, as well as slaughter facility representatives whose facilities handle certified swine. In most instances, the information relating to a pork production site's adherence to required good production practices would be collected during the audit. Completed forms would be submitted to the local APHIS area office. Site suitability for program enrollment or certification would be determined by the local APHIS area office. Program data would be entered locally. National summary data would be available to APHIS personnel involved in administering the program. Producers choosing to participate in the program would be subject to certain recordkeeping requirements that evidence their adherence to all of the required good production practices. Producers would have to maintain the following records: Animal disposal plan, animal movement record, feed mill quality assurance affidavit (if applicable), rodent control logbook, and waste feeding logbook (if applicable). Slaughter facilities handling certified swine also would be subject to certain recordkeeping requirements as to the number of certified swine processed, the source of the certified swine, and test results relating to process-verification testing. Such slaughter facilities also would be required to have documented procedures on how certified swine under its control, and the edible pork products derived from these animals, would remain segregated from swine and pork from noncertified sources. Approved laboratories that perform process-verification testing under the Trichinae Certification Program would be required to maintain written procedures that pertain to the performance of process-verification testing. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1)Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2)Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; *e.g.* , permitting electronic submission of responses). *Estimate of burden:* Public reporting burden for this collection of information is estimated to average 0.3842102 hours per response. *Respondents:* Auditors, herd owners, slaughter facilities, and approved laboratories. *Estimated annual number of respondents:* 54,500. *Estimated annual number of responses per respondent:* 2.992532. *Estimated annual number of responses:* 163,093. *Estimated total annual burden on respondents:* 62,662 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at
(301)734-7477. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at
(301)734-7477. List of Subjects 9 CFR Part 149 Animal diseases, Hogs, Laboratories, Meat and meat products, Meat inspection, Reporting and recordkeeping requirements. 9 CFR Part 160 Veterinarians. 9 CFR Part 161 Reporting and recordkeeping requirements, Veterinarians. Accordingly, we propose to amend title 9 CFR chapter I as follows: SUBCHAPTER G—LIVESTOCK IMPROVEMENT 1. In subchapter G, the subchapter heading would be revised to read as set forth above. 2. In subchapter G, a new part 149 would be added to read as follows: PART 149—VOLUNTARY TRICHINAE CERTIFICATION PROGRAM Sec. 149.0 Purpose and scope. 149.1 Definitions. 149.2 Program participation. 149.3 Site audit. 149.4 Spot audit. 149.5 Offsite identification and segregation of certified swine. 149.6 Slaughter facilities. 149.7 Recordkeeping at site. 149.8 Program fees and charges. 149.9 Pilot program sites. Authority: 7 U.S.C. 8301-8317; 7 U.S.C. 1622; 7 CFR 2.22, 2.80, and 371.4. § 149.0 Purpose and Scope. The Trichinae Certification Program described in this part is intended to enhance the ability of swine producers, as well as slaughter facilities and other persons that handle or process swine from pork production sites that have been certified under the program, to export fresh pork and pork products to overseas markets. § 149.1 Definitions. *Accredited veterinarian.* A veterinarian approved by the APHIS Administrator in accordance with part 161 of this chapter to perform functions specified in subchapters B, C, D, and G of this chapter. *Agricultural Marketing Service (AMS).* The Agricultural Marketing Service of the United States Department of Agriculture. *AMS Administrator.* The Administrator, Agricultural Marketing Service, or any person authorized to act for the AMS Administrator. *AMS representative.* Any individual employed by or acting as an agent on behalf of the Agricultural Marketing Service who is authorized by the AMS Administrator to perform services required by this part. *Animal and Plant Health Inspection Service (APHIS).* The Animal and Plant Health Inspection Service of the United States Department of Agriculture. *Animal disposal plan.* A written document that describes methods for the removal and disposal of dead swine or swine remains from a pork production site. *Animal movement record.* A written record of the movement of swine into or from a pork production site. *APHIS Administrator.* The Administrator, Animal and Plant Health Inspection Service, or any person authorized to act for the APHIS Administrator. *APHIS representative.* Any individual employed by or acting as an agent on behalf of the Animal and Plant Health Inspection Service who is authorized by the APHIS Administrator to perform the services required by this part. *Approved laboratory.* A non-Federal laboratory approved by the Agricultural Marketing Service and recognized by the APHIS Administrator or FSIS Administrator for performing validated tests to determine the presence of trichinae infection in reference to the Trichinae Certification Program. *Audit.* An inspection process, as provided in this part, that generates a written record documenting a pork production site's adherence to the required good production practices. *Auditor.* A qualified accredited veterinarian
(QAV)or a qualified veterinary medical officer
(QVMO)who is trained and authorized by APHIS to perform auditing activities under the Trichinae Certification Program. *Certification (certified).* A designation given by the APHIS Administrator to a pork production site for compliance with good production practices and other program requirements of the Trichinae Certification as provided in this part. *Certified pork.* 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. *Certified production site.* A pork production site that has attained a program status of Stage II or higher, based on adherence to good production practices and other program requirements as provided in this part. *Certified swine.* Swine produced under the Trichinae Certification Program on a certified production site. *Decertification (decertified).* Removal of the certified status of a production site by the APHIS Administrator when it has been determined that the criteria of the Trichinae Certification Program are not being met or maintained. *Enzyme-linked immunosorbent assay (ELISA).* A method of testing swine for the presence of trichinae infection by looking for antibodies to *Trichinella spiralis* in the sera, plasma, whole blood, tissue fluid, or meat juice of swine. *EPA* . The United States Environmental Protection Agency. *Feed mill quality assurance affidavit* . A written statement signed by the feed mill representative and the producer that documents the quality and safety of feed or feed ingredients delivered from the feed mill to the pork production site. *Food Safety and Inspection Service (FSIS).* The Food Safety and Inspection Service of the United States Department of Agriculture. *FSIS Administrator.* The Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. *FSIS program employee.* Any individual employed by or acting as an agent on behalf of the Food Safety and Inspection Service who is authorized by the FSIS Administrator to perform the services required by this part. *Good manufacturing practices.* Feed manufacturing practices that reduce, eliminate, or avoid the risk of exposure of swine to *Trichinella spiralis* . *Good production practices.* Pork production management practices that reduce, eliminate, or avoid the risk of exposure of swine to *Trichinella spiralis* . *Harborage.* Any object, debris, clutter, or area that could serve as shelter or refuge for rodents or wildlife. *Laboratory approval audit.* An audit performed by AMS representatives to determine if a laboratory meets minimum requirements for approval, as established by AMS, for performing validated tests under this part. *National Trichinae Certified Herd.* All swine raised on certified production sites in the United States. *Person.* Any individual, corporation, company, association, firm, partnership, society, joint stock company, or other legal entity. *Pest control operator.* A person trained and State-licensed in the control of pests and vermin (particularly rodents). *Pooled sample digestion method (digestion method).* A method of testing swine for trichinae infection by identifying the presence of *Trichinella spiralis* from a sample of the animal's muscle tissue. *Pork production site (site).* A geographically definable area that includes pork production facilities and ancillary structures under common ownership or management systems and the surrounding space within a 100-foot perimeter of the swine housing and feeding areas. *Positive test result.* Outcome of a validated test indicating the presence of *Trichinella spiralis* . *Process-verification testing.* Testing of a statistically valid sample of swine belonging to the National Trichinae Certified Herd at the time of slaughter using a validated test to verify that the adherence to good manufacturing practices and good production practices is resulting in the absence of *Trichinella spiralis* infection in swine from that herd. *Producer.* An individual or entity that owns or controls the production or management of swine. *Qualified accredited veterinarian (QAV).* An accredited veterinarian who has been granted an accreditation specialization by the APHIS Administrator pursuant to § 161.5 of this chapter based on completion of an APHIS-approved 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 by this part. *Qualified veterinary medical officer (QVMO).* A VMO of the State or Federal Government who is trained in good production practices and is authorized by the APHIS Administrator to perform site audits, spot audits, and other specified program services required by this part. *Rodent control logbook.* A written record that documents a rodent control program for a pork production site. *Site audit.* An audit, performed by a QAV or a QVMO, to determine the trichinae risk factor status of a pork production site based on the site's adherence to all of the required good production practices that reduce, eliminate, or avoid the risk of exposure of swine to *Trichinella spiralis* . *Slaughter facility.* A slaughtering establishment operating under the Federal Meat Inspection Act (21 U.S.C. 601 *et seq.* ) or a State meat inspection act that receives certified swine under the Trichinae Certification Program. *Slaughter facility representative.* Any individual employed by, or acting as an agent on behalf of, a slaughter facility who is authorized by the slaughter facility to perform the specified program services required by this part. *Spot audit.* An audit of a certified pork production site performed by a QVMO to ensure program integrity and consistency. *Stage I enrolled.* Preliminary program status of a pork production site attained when the APHIS Administrator approves the outcome of an initial site audit. *Stage II certified.* Program status attained upon APHIS approval of a site audit of a Stage I enrolled site. *Stage III certified.* Program status attained upon APHIS approval of a site audit of a Stage II certified site and maintained upon APHIS approval of subsequent site audits for renewal of Stage III certified status. *Sterile zone.* An open area immediately adjacent to and surrounding those building(s) used to house and feed swine that serves as both a buffer and detection zone for rodent and wildlife activity. *Temporary withdrawal* . The voluntary withdrawal of a certified production site from the Trichinae Certification Program at the request of the producer for a period not to exceed 180 days. *Trichinae.* A generic term that refers to *Trichinella spiralis* . *Trichinae Certification Program (program).* A voluntary pre-harvest pork safety program in which APHIS certifies pork production sites that follow all of the required good production practices that reduce, eliminate, or avoid the risk of exposure of swine from their sites to *Trichinella spiralis* . *Trichinae Identification Number (TIN).* A number assigned to a pork production site by the APHIS Administrator. *Trichinella spiralis* . A parasitic nematode (roundworm) capable of infecting many warm-blooded carnivores and omnivores, including swine. *USDA.* The United States Department of Agriculture. *Validated test.* An analytical method licensed by APHIS or accepted by AMS for the diagnosis of *Trichinella spiralis* in swine. *Veterinary medical officer (VMO)* . A veterinarian employed by the State or Federal Government who is authorized to perform official animal health activities on their behalf. *Waste feeding logbook.* 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. § 149.2 Program participation. A producer's initial enrollment and continued participation in the trichinae certification program requires that the producer adhere to all of the good production practices, as confirmed by periodic site audits, and comply with other recordkeeping and program requirements provided in this part. Pork production sites accepted into the program by APHIS will participate under one of the following three program stages:
(a)*Stage I enrolled status.*
(1)Stage I enrolled status signifies that the site has met good production practices and other recordkeeping and program requirements provided in this part.
(2)Swine from a Stage I enrolled site cannot be identified as products from a certified production site.
(3)A Stage I enrolled site must complete a site audit for Stage II certified status in accordance with § 149.3(d). Under § 149.3(d), the site audit must be performed no sooner than 150 days from the date the site was awarded Stage I enrolled status, and must be completed, with the audit form and payment submitted to APHIS, no later than 210 days from the date the site was awarded Stage I enrolled status.
(4)A Stage I enrolled site that is found not to be adhering to one or more good production practices as a result of a site audit or spot audit, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment for consideration as a Stage II certified site, will lose its status as a Stage I enrolled site.
(b)*Stage II certified status* .
(1)Stage II certified status signifies that the site is adhering to all of the required good production practices and other recordkeeping and program requirements provided in this part.
(2)An APHIS-issued certificate or letter indicating the site's status as a Stage II certified site must be filed at the site and be readily available for inspection.
(3)Swine from a Stage II certified site may be identified as certified product from a certified production site.
(4)A Stage II certified site must complete a site audit for Stage III certified status in accordance with § 149.3(e). Under § 149.3(e), the site audit must be performed no sooner than 240 days from the date the site was awarded Stage II certified status, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days from the date the site was awarded Stage II certified status.
(5)A Stage II certified site that is found not to be adhering to one or more good production practices as a result of a site audit or spot audit, or that fails to meet the Stage III site audit requirements of § 149.3(e) within the prescribed timetable, will be decertified by APHIS as provided in paragraph
(e)of this section. During the time a site is decertified, swine from that site cannot be identified as product from a certified production site.
(c)*Stage III certified status.*
(1)Stage III certified status signifies that the site is adhering to all of the required good production practices and other recordkeeping and program requirements provided in this part.
(2)An APHIS-issued certificate or letter indicating the site's status as a Stage III certified site must be filed at the site and be readily available for inspection.
(3)Swine from a Stage III certified site may be identified as certified products from a certified production site.
(4)A Stage III certified site that is found not to be adhering to one or more good production practices as a result of a site audit or spot audit, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment to determine its continued participation as a Stage III certified site, will be decertified by APHIS as provided in paragraph
(e)of this section. During the time a site is decertified, swine from that site cannot be identified as product from a certified production site.
(d)*Change of ownership.*
(1)*Stage I enrolled site.* If there is a change in ownership in a Stage I enrolled site, and the new ownership wishes to remain in the program, then the Stage I enrolled site will remain on the same timetable as under the previous ownership for purposes of completing a site audit for Stage II certified status. No additional site audit is necessary as a result of the change of ownership of the site.
(2)*Stage II or Stage III certified sites.* Within 60 days of a change in 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. It is the new ownership's responsibility that a site audit be performed within 60 days of the change in ownership, otherwise the site will be decertified. 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. 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. If the results of the site audit do not meet program requirements, as determined by APHIS, the Stage II or Stage III site will be decertified. Once a site is decertified by APHIS, either because the new ownership fails to arrange for a site audit to be performed within the allotted 60-day time period, or because the site is found not to meet program requirements, a producer wishing to participate in the program again must follow the procedures for requesting an initial audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage I site audit, a new program anniversary date for that site will be established based on the date of reenrollment.
(e)*Site decertification and program withdrawal.*
(1)*Decertification by APHIS.*
(i)A Stage II or Stage III certified site that is found not to be adhering to one or more 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.
(ii)During the time a site is decertified, swine from such sites cannot be identified as certified product from a certified production site.
(iii)Once a site is decertified by APHIS, a producer wishing to participate in the program again must follow the procedures for requesting a site audit for Stage I enrolled status. If a decertified site is reenrolled after a successful Stage I site audit, a new program anniversary date for that site will be established based on the date of recertification. If a decertified site is recertified after a successful Stage II site audit, a new program anniversary date for that site will be established based on the date of recertification.
(2)*Temporary withdrawal by producer.*
(i)A producer may request that one or more certified production sites be temporarily withdrawn. A producer's request must be made in writing and is subject to the APHIS Administrator's approval.
(ii)Each certified production site can be temporarily withdrawn no more than once every 2 years for a period not to exceed 180 days.
(iii)During the time a site is temporarily withdrawn:
(A)Swine from such sites cannot be identified as certified product from a certified production site; and
(B)The producer must continue to adhere to all good production practices and other recordkeeping and program requirements provided in this part, unless specifically waived by the Administrator, including 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.
(iv)Before being reinstated as a certified production site, the temporarily withdrawn site must pass a site audit to indicate that it is adhering to all good production practices (including any practices previously waived by the Administrator) as follows:
(A)The site audit must be performed while the site is still under temporary withdrawal status. If swine 5 weeks of age or older originating from 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.
(B)If the results of the site audit are satisfactory and it is determined that the site is adhering to good production practices and other program requirements provided in this part, then the withdrawn site will be reinstated as a Stage II certified site. The timetable for performing future site audits for attaining and renewing Stage III certified status will be based on the date the site was reinstated as a Stage II certified site.
(C)If the results of the site audit are not satisfactory 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 will be decertified by APHIS. Once the site is decertified by APHIS, the producer must follow the procedures for requesting an initial site audit for Stage I enrolled status in order for the site to be reenrolled in the program. If a site is decertified by APHIS and then reenrolled after a successful Stage I site audit, a new program anniversary date for that site will be established based on the date of enrollment.
(3)*Program withdrawal.*
(i)If a producer decides to withdraw one or more of pork production sites from the program, then it is the producer's responsibility to notify the APHIS Administrator in writing of this intent. When this is done, the site will be removed from the program.
(ii)If at a later date the producer requests that a site be reinstated in the program, then the producer must follow the procedures for requesting an initial audit for Stage I enrolled status. If a withdrawn site is reenrolled after a successful Stage I site audit, then a new program anniversary date for that site will be established based on the date of reenrollment.
(f)*Request for review.* If there is a conflict as to any material fact relating to the results of a site audit, spot audit, or other determination affecting a producer's program status or ability to participate in the program, the producer may submit a written request for review to the Administrator. The producer must include in the request the reasons, including any supporting documentation, why the audit result or other determination should be different than the result or determination made by the Administrator. The initial audit result or other determination will remain in force pending the completion of the Administrator's review. The decision by the Administrator upon reviewing the producer's written request will be final. § 149.3 Site audit.
(a)*General.*
(1)The producer must contact a QAV to request a site audit. A list of available QAVs may be obtained by accessing the Trichinae Certification Program Web site on the Internet at *http://www.aphis.usda.gov/vs/trichinae* , or by contacting the APHIS area office. 2 If a QAV is not available to perform a site audit, the producer may then contact the APHIS area office to request that a QVMO perform the site audit. The site audit is to be arranged at a mutually agreed-upon time. 2 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* .
(2)The producer or the producer's designated representative will accompany the auditor during the site audit.
(3)During the site audit, the auditor will record whether the producer is adhering to all of the required good production practices at the site, as provided in paragraph
(b)of this section, in order to reduce, eliminate, or avoid the risk of exposure of swine to *Trichinella spiralis* .
(4)The auditor will use APHIS-approved audit forms in performing the site audit. After the auditor has completed all sections of the audit form, the producer or the producer's designated representative must sign the audit form attesting to the accuracy of the information obtained during the site audit and to evidence his or her intent to continue adhering to the good production practices and other program requirements, as provided in this part. The auditor also must sign the audit form at this time.
(5)The producer is responsible for the cost of each site audit performed at the pork production site. If a QAV performs the site audit, then the producer will pay the QAV directly at a mutually agreed-upon time and rate. If a QVMO performs the site audit, then the producer will pay the QVMO at the time the site audit is performed in accordance with the rate and other conditions set by the QVMO's governmental employer. If an APHIS-employed QVMO performs the site audit, then the producer will pay APHIS by certified check or U.S. money order for this service at a rate determined in accordance with § 149.8.
(6)In addition to the cost of the site audit, the producer is also responsible for paying a separate program fee in an amount specified in § 149.8 to cover APHIS' administrative costs in processing the audit and operating the program. This program fee, payable to APHIS by certified check or U.S. money order, must be remitted to the auditor at the time each site audit is performed.
(7)The auditor will submit the completed audit form, program fee, and payment for the services of an APHIS-employed QVMO, if applicable, to the nearest APHIS area office. If a QAV performs the site audit, the producer will be responsible for ensuring that the QAV submits the completed audit form and program fee to APHIS in a timely manner.
(8)Upon receipt of the completed audit form and payment, APHIS will determine the initial enrollment or certification status for the site based on an evaluation of the site audit. APHIS will provide the producer with written notification of the audit results. Pork production sites that meet all good production practices as provided in paragraph
(b)of this section, as well as other program requirements provided in this part, will be issued program status at the appropriate program stage.
(9)If the site audit shows that the site does not meet all good production practices or other program requirements, APHIS will provide the producer with written notification that includes documentation of the deficiencies that prevented the site from being conferred program status.
(b)*Good production practices.* In a site audit, the auditor will determine whether all of the required good production practices are being carried out at the site to reduce, eliminate, or avoid the risk of exposure of swine to *Trichinella spiralis* as follows:
(1)The movement of all non-breeding swine 5 weeks of age or older into or from the pork production site must be documented in an animal movement record, as provided in § 149.7, that ensures that all such swine moved into or from the site can be subsequently traced back to that site, or to any previous site (if applicable).
(2)All non-breeding swine entering a site must have originated from another certified production site, except that non-breeding swine less than 5 weeks of age may have originated from either a certified or noncertified production site. The animal movement record must include the 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 must provide the name and full address of the noncertified site where the swine originated.
(3)Feed or feed ingredients from offsite sources that are used at the site must meet good manufacturing practices or other quality assurance standards recognized by the feed industry. The adherence to good manufacturing practices or other quality assurance standards must be documented in a feed mill quality assurance affidavit, as provided in § 149.7.
(4)Swine housing and feeding areas, feed preparation and storage areas, and office areas and connecting hallways at the site must be inspected regularly and found free of fresh signs rodent and wildlife activity. Any movable harborage (exterior or interior) on the site that is not necessary to the day-to-day operation of the site must be removed. Harborage that cannot be removed or is movable but necessary to the day-to-day operation of the site ( *e.g.* , bales of hay, etc.) must be checked for signs of rodent or wildlife activity ( *e.g.* fresh droppings, tracks, signs of gnawing or burrowing). In addition, domesticated animals, including pets such as dogs and cats, must 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 consists of fresh rodent droppings, fresh gnawing marks, new structural damage, rodent urine, rodent blood, rodent smear marks (body oil), rodent tracks, or recent burrowing or burrow use. Evidence of wildlife activity consists of wildlife feces, footprints, fur, or hair observed in or near the stored feed or feed ingredients, dead or live wildlife observed in or near the stored feed or feed ingredients, or wildlife burrows or nests observed in or near the stored feed or feed ingredients). Exterior rodent bait stations and/or traps must 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 must 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 must be placed near high-risk rodent zones such as entryways, hallways, office areas, swine load out areas, vents, cool cells, storage areas, utility rooms, cabinets, locker rooms, bathrooms, and break rooms, and systematically maintained. Interior rodent bait stations and/or traps must be placed so that swine will not come in contact with the bait or trap. Rodent bait stations and/or traps also must be placed near exterior or interior harborage on the site that cannot be removed or that is movable but necessary to the day-to-day operation of the site. In all instances, rodent bait stations must be intact, systematically maintained, and contain fresh bait that consists of an EPA-registered rodenticide formulation that is applied according to its label. In addition, a sterile zone must be maintained around the perimeter of those building(s) used to house and feed swine. The sterile zone must be devoid of any harborage or feed or water sources that could attract rodents or wildlife, but must contain rodent bait stations and/or rodent traps. The sterile zone also must be devoid of any vegetation unless it is decorative vegetation that is well maintained (i.e., residential height grass, flowers, shrubs, or trees). A sterile zone with decorative vegetation will require increased rodent control measures. The producer must provide documentation of rodent control practices by maintaining at the site an up-to-date rodent control logbook with a site diagram and other recordkeeping evidencing implementation of rodent control measures, which can include documents provided by a pest control operator, as provided in § 149.7.
(5)Feed or feed ingredients stored at the site must be prepared, maintained, and handled in a manner that protects the feed or feed ingredients from possible exposure to or contamination by rodents or wildlife. Any movable harborage in the immediate vicinity of feed production and feed storage areas that is not necessary to the day-to-day operation of the site must be removed. Harborage that cannot be removed or harborage that is movable but necessary to the day-to-day operation of the site (e.g., bales of hay, etc.) must be checked for signs of rodent or wildlife activity. Rodent bait stations and/or traps must be placed around (and in, if applicable) all feed preparation and storage areas, as well near any harborage in the vicinity that cannot be removed or that is movable but necessary to the day-to-day operation of the site. Rodent bait stations must be intact, systematically maintained, and contain fresh bait that consists of an EPA-registered rodenticide formulation that is applied according to its label. In addition, feed or feed ingredients that are stored in paper bags must be elevated off the floor and be a sufficient distance away from the walls to allow for inspection, baiting, and/or trapping. The rodent control logbook, as provided in § 149.7, must document that adequate rodent control procedures have been implemented in the feed production and feed storage areas.
(6)Swine must not have access to wildlife harborage or dead or live wildlife at the site. This harborage limitation includes wood or wooded lots and other natural wildlife access areas. Dead or live wildlife must not be intentionally fed to swine.
(7)If meat-containing waste is fed to swine at the site, then the producer must hold a license or permit that authorizes the feeding of such waste to swine. Cooking times and temperatures of meat-containing waste must be consistent with applicable State and Federal laws and regulations. In addition, up-to-date records of waste feeding and cooking practices, in the form of a waste feeding logbook must be maintained at the site, as provided in § 149.7. Cooked food waste products that are stored prior to feeding must not be mixed or contaminated with uncooked or undercooked meat waste material. Household food waste, regardless of whether it contains meat or is cooked or undercooked, also must not be fed to swine.
(8)Procedures must be in place and carried out for the prompt removal and proper disposal of dead swine or swine remains found in pens in order to eliminate the opportunity for cannibalism, as well as to prevent the attraction of rodents or wildlife. Such procedures must be documented in the animal disposal plan, as provided in § 149.7.
(9)General hygiene and sanitation of the site must be maintained at all times to prevent the attraction of rodents and wildlife. Solid non-fecal waste (facility refuse) must be placed in covered receptacles and be regularly removed from the site. Spilled feed also must be regularly removed and properly disposed of.
(10)All records required under § 149.7 must be kept up-to-date and readily available for inspection at the site.
(c)*Initial site audit for Stage I enrolled status.*
(1)Producers interested in participating in the program should request and review a pre-audit information packet prepared by APHIS that discusses the program, as well as the steps in preparing for and requesting an initial site audit. 3 When the producer and the producer's herd health personnel believe that a site meets program standards, the producer may arrange for an initial site audit, as provided in paragraph
(a)of this section. 3 The pre-audit information packet may be obtained from a qualified accredited veterinarian (QAV), State or Federal animal health offices, or the National Pork Board, or by writing to: USDA, APHIS, Veterinary Services, Trichinae Certification Program, 210 Walnut St., Room 891, Des Moines, IA 50309. A pre-audit packet also may be requested electronically through the program Web site on the Internet at *http://www.aphis.usda.gov/vs/trichinae.*
(2)Upon completion of the initial site audit and submission of the completed audit form and payment, APHIS will review the completed audit form and make a determination within 30 days as to enrollment of the site in the program. A pork production site that is found to meet all good production practices and other program requirements in this part will be awarded Stage I enrolled status.
(d)*Site audit for Stage II certified status.*
(1)A producer of a Stage I enrolled site must arrange for another site audit for Stage II certified status. The site audit must be performed no sooner than 150 days ( *i.e.* , approximately 5 months) from the date the site was awarded Stage I enrolled status, and must be completed, with the audit form and payment submitted to APHIS, no later than 210 days ( *i.e.* , approximately 7 months) from the date the site was awarded Stage I enrolled status.
(2)APHIS will review the completed audit form and make a determination as to Stage II certified status within 7 days of receipt of the audit form and payment.
(i)A Stage I enrolled site that is found to meet all good production practices and other program requirements in this part will be awarded Stage II certified status.
(ii)A Stage I enrolled site that is found, during a site audit, not to be adhering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, will not be awarded Stage II certified status and will lose its program status as a Stage I enrolled site.
(e)*Site audit for Stage III certified status.*
(1)A producer of a Stage II enrolled site must arrange for another site audit for Stage III certified status. The site audit must be performed no sooner than 240 days (i.e., approximately 8 months) from the date the site was awarded Stage II certified status, and must be completed, with the audit form and payment submitted to APHIS, no later than 300 days (i.e., approximately 10 months) from the date the site was awarded Stage II certified status.
(2)APHIS will review the completed audit form and make a determination as to Stage III certified status within 30 days of receipt of the audit form and payment.
(i)A Stage II certified site that is found to meet all good production practices and other program requirements in this part will be awarded Stage III certified status.
(ii)A Stage II certified site that is found, during a site audit, not to be adhering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, will be subject to decertification by APHIS as provided in § 149.2(e).
(f)*Site audit for renewal of Stage III certified status.*
(1)A producer seeking to renew a site's Stage III certified status must arrange for another site audit. The site audit must be performed no sooner than 14 months from the date the site was awarded Stage III certified status or the date that status was last renewed, and must be completed, with the audit form and payment submitted to APHIS, no later than 16 months from either the date the site was awarded Stage III certified status or the date that the status was last renewed.
(2)APHIS will review the completed audit form and make a determination as to renewing the site's Stage III certified status within 30 days of receipt of the audit form and payment.
(i)A Stage III certified site that is found to meet all good production practices and other program requirements in this part will have its status Stage III certified site renewed.
(ii)A Stage III certified site that is found, during a site audit, not to be adhering to one or more good production practices, or that fails to follow the prescribed timetable for completing a site audit and submitting the completed audit form and payment, will be subject to decertification by APHIS as provided in § 149.2(e). § 149.4 Spot audit.
(a)In addition to regularly scheduled site audits, certified production sites will be subject to spot audits.
(1)*Random spot audit.* Certified production sites will be selected by the APHIS Administrator at random for a spot audit in order to:
(i)Ensure the integrity of the audit process;
(ii)Verify that the audit process is performed in a consistent manner across the program; and
(iii)Verify that all required good production practices are being maintained between regularly scheduled site audits.
(2)*Spot audit for cause.* A certified production site may be subject to a spot audit to trace back and investigate any positive test results as a result of testing of certified swine from that site at the slaughter facility.
(b)All spot audits will be performed by a QVMO. The producer of the certified production site subject to spot audit will not be charged for the spot audit. APHIS will provide the producer with written notification of the results of the spot audit, including documentation of any deficiencies noted during the audit. If the site is found not to be adhering to one or more of the required good production practices, then the site will be subject to decertification by APHIS as provided in § 149.2(e). § 149.5 Offsite identification and segregation of certified swine. Certified swine moved from a certified production site to another location, whether to another certified production site, buying station, collection point, or slaughter facility, must remain segregated from noncertified swine at all times and otherwise maintain their identity as certified swine in such a way that they could be readily traced back to the certified production site from which they came. Information relating to the identification of the certified swine must be documented in the animal movement record maintained by the producer. Failure to properly segregate or maintain the identity of certified swine from noncertified swine after leaving the certified production site will result in the loss of certified status for that shipment of swine. § 149.6 Slaughter facilities. Only slaughter facilities that are under continuous inspection by the Food Safety and Inspection Service or under State inspection that the Food Safety and Inspection Service has recognized as equivalent to Federal inspection may participate in the program. To participate in the program, slaughter facilities must follow the relevant provisions of this section relating to verification, segregation, testing, and recordkeeping. Participating slaughter facilities that fail to comply with any of the applicable requirements of this section will not be allowed to continue to participate in the Trichinae Certification Program and the pork or pork products prepared by the facility will not be eligible for a certificate of export that identifies the product as meeting the standards of the Trichinae Certification Program.
(a)*Verification of certification.* A slaughter facility receiving certified swine must verify the current certification status of the pork production site from which the animals came. The current certification status may be verified by maintaining dated certification documentation on file or by accessing the Trichinae Certification Program Web site on the Internet at *http://www.aphis.usda.gov/vs/trichinae.* If the slaughter facility is unable to verify a site's certification status through documentation on file or through the program Web site, the slaughter facility then should contact the APHIS area office in the State where the site is located.
(b)*Maintaining identity and segregation of certified swine and pork products.* For certified swine to be identified as certified pork, certified swine and edible pork products derived from certified swine must remain segregated from swine and edible pork products from noncertified sites throughout receiving, handling, and processing at the slaughter facility, as well as while awaiting shipment from the facility. The slaughter facility must maintain the identity of the certified swine or pork in a manner that allows the certified swine or pork to be traced back to the certified production site from which it came. A slaughter facility's failure to properly segregate or maintain the identity of certified swine and edible pork products derived from the certified swine will result in the loss of certified status for that shipment of swine, as well as the edible pork products derived from those animals.
(c)*Process-verification testing.* A slaughter facility processing certified swine is responsible for performing process-verification testing at its expense to determine the *Trichinella spiralis* infection status of certified swine under its control as follows:
(1)*Validated tests.* Process-verification testing must be performed by using a validated test. 4 4 A copy of the testing methods and checklist for conducting validated tests may be obtained by contacting the Trichinae Program Manager, USDA, AMS, Science and Technology, Technical Services Branch, 1400 Independence Avenue, SW., Mail Stop 0272, Washington, DC 20250-0272; or by telephone at
(202)690-0621.
(2)*Laboratory approval.* Process-verification testing must be performed in an approved laboratory that has been approved for trichinae testing by the Agricultural Marketing Service (AMS). 5 The approved laboratory may be maintained and operated by the slaughter facility or by another business entity either on the premises of the slaughter facility or at another location. Laboratory staff performing process-verification testing must be accredited by AMS to perform this program function. For purposes of quality assurance, all laboratory staff approved to perform process-verification testing will receive periodic proficiency test panels from AMS that must be analyzed correctly in order to maintain their approval status. 5 A copy of the AMS Trichinae Accredited Laboratory Program Requirements may be obtained by contacting the Trichinae Program Manager (see footnote 3).
(3)*Testing sample size and frequency.* Process-verification testing must meet the following minimum requirements relating to sample size and frequency:
(i)Slaughter facility representatives shall determine the yearly processing capacity of the slaughter facility for the next 12 months. Officials may use the processing capacity over the previous 12 months if this period is representative of a typical processing year.
(ii)Slaughter facility representatives shall estimate the percentage of swine processed that are likely to come from certified production sites considering all swine expected to be processed at the slaughter facility during the selected 12-month period. Swine that come from certified production sites are considered the eligible population to be sampled.
(iii)Slaughter facility representatives shall use the Trichinae Certification Slaughter Facility Sample Size Determination Table (see table 1) to find the number of samples to collect from the population of swine from certified production sites. If the eligible population is not listed in table 1, the next largest number will be used to determine the number of samples to collect. Select the number of samples to collect from the column that reflects a 99 percent confidence level of detecting a positive carcass in the population. The number selected from table 1 will be the total number of samples that slaughter facility representatives must collect and test per year and per month during the selected 12-month period. Table 1.—Trichinae Certification Slaughter Facility Sample Size Determination Certified swine from certified production sites processed per slaughter facility per year Samples to collect from the population per year at a 99 percent confidence level Samples to collect from the population per month at a 99 percent confidence level 1,000 1,000 84 5,000 4,996 417 25,000 18,938 1,578 100,000 29,828 2,486 200,000 32,462 2,705 400,000 33,899 2,825 1,000,000 34,802 2,900 2,000,000 35,110 2,926 4,000,000 35,266 2,939 5,000,000 35,297 2,942
(iv)For each sample collected, slaughter facility representatives must maintain the identity of the sample using the TIN of the certified production site that was the source of the swine from which the sample was taken.
(v)FSIS program employees at the slaughter facility will review and verify that an adequate number of samples have been collected and that proper frequency of collection is maintained. FSIS will report this information to APHIS.
(vi)AMS representatives will verify through a laboratory approval audit that the laboratory performing process-verification testing is correctly following written procedures relating to the receipt, handling, identification, and testing of samples. These written procedures must be maintained by the laboratory in a quality assurance manual, as provided in paragraph (c)(6) of this section. In addition, a laboratory that performs process-verification testing at a location other than the slaughter facility must include a declaration of methodology used to test samples when providing test results.
(vii)The APHIS Administrator may, at APHIS' expense, periodically request that testing be performed on swine brought to the slaughter facility from specific certified production sites. Requests to test swine from specific certified production sites will count towards the slaughter facility's total monthly testing requirement.
(4)*Results of testing.*
(i)The results of all process-verification testing relating to certified swine handled at the slaughter facility must be retained in a separate file or notebook as written records at the slaughter facility and must be readily available for inspection by FSIS program employees.
(ii)FSIS will report to APHIS the results of all process-verification testing.
(iii)In the event of a positive test result, the slaughter facility representative must notify the FSIS program employee designated by the FSIS Administrator immediately, who in turn will report the 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. The following sequence of events must take place following a positive test result:
(A)If a test sample yields a positive test result based on the digestion method, the certified production site that was the source of the swine from which the sample was taken will be decertified.
(B)If a test sample yields a positive test result based on an ELISA method and is confirmed positive by further testing using the digestion method, the certified production site that was the source of the swine from which the sample was taken will be decertified.
(C)If a test sample yields a positive test result based on an ELISA method, but is not confirmed positive by further testing using the digestion method, then the certified production site that was the source of the swine from which the sample was taken will be investigated by APHIS. ( *1* ) The investigation may include a spot audit of the affected site. Further testing of animals or carcasses from the affected site also may be performed as part of the investigation. This investigation would determine if the production facility has sufficient safeguards and is following good production practices. ( *2* ) While the affected site is under investigation, its program status as a certified production site will be suspended. While the site is under suspension, the producer must continue to adhere to all of the required good production practices and other recordkeeping and program requirements provided in this part; however, swine from the suspended site cannot be identified as product from a certified production site. The Administrator will determine the program status of the affected site within 30 days of the initiation of the suspension. ( *3* ) A finding that risk factors are inadequately addressed in the site investigation or the finding of additional positive test results based on samples from animals or carcasses from the affected site will be grounds for APHIS decertification of the site.
(5)*Slaughter facility recordkeeping.*
(i)All slaughter facilities that receive certified swine must maintain records relating to such animals, including the number of certified swine processed, the source of the certified swine, including the TIN of the certified production site from which the swine came from, and all test results relating to process-verification testing. Records relating to certified swine must be retained at the slaughter facility for a period of at least 3 years following the processing of such animals.
(ii)All slaughter facilities must have documented procedures on how certified swine under its control, and edible pork products derived from certified swine, will remain segregated from swine and edible pork products from noncertified sites throughout receiving, handling, and processing at the facility, as well as while awaiting shipment from the facility. The slaughter facility must also have documented procedures for maintaining the identity of the certified swine or pork with respect to the certified production site from which it came.
(iii)All such records and other documentation required to be maintained by slaughter facilities under this part must be readily available for inspection by FSIS program employees.
(6)*Approved laboratory recordkeeping.* Approved laboratories must have written procedures that specify standards for sample size, sample handling, sample identification, and sample test methods used in process-verification testing. All such written procedures must be maintained in a laboratory quality assurance manual specifically for this program, or as a separate section of an existing laboratory quality assurance manual, and must be retained at the approved laboratory throughout the time the approved laboratory is performing process-verification testing under this program. All such written procedures relating to process-verification testing must be readily available for inspection by FSIS program employees or AMS representatives.
(7)*Slaughter facility overall responsibility for process-verification testing.* The slaughter facility is responsible for obtaining testable samples and for ensuring that the correct number of testable samples are sent to the testing laboratory. Once the slaughtering facility receives the test results, it is responsible for reporting those results in its facility trichinae testing record. Moreover, the slaughter facility is responsible for ensuring that process-verification testing is carried out in accordance with this part, including the reporting of test results, regardless of whether it is performed at the slaughter facility or another location, and regardless of whether the testing is performed by slaughter facility personnel or other persons. § 149.7 Recordkeeping at site.
(a)Stage I enrolled sites, Stage II or Stage III certified sites, and any site that has been suspended or voluntarily decertified must maintain the following program records: Animal disposal plan, animal movement record, feed mill quality assurance affidavit (if applicable), rodent control logbook, and waste feeding logbook (if applicable). All such records must be readily available for inspection at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours.
(1)*Animal disposal plan.* The animal disposal plan must meet the following minimum requirements:
(i)It must provide for the removal of all dead swine or swine remains from swine pens immediately upon detection. Inspections for purposes of detecting dead animals must occur at least once every 24 hours.
(ii)It must specify how often and at what intervals the swine pens are observed each day.
(iii)It must provide for the proper storage of dead swine or swine remains in accordance with local, State, and Federal laws and regulations. If the carcass storage facility or composting facility is located on the site, then the animal disposal plan must provide for a storage or composting facility that precludes rodent or wildlife contact with dead swine or swine remains being stored or composted.
(iv)It must provide for the disposal of swine and other mammals by rendering, incineration, composting, burial, or other means, as allowed by and in accordance with local, State, and Federal laws and regulations. For sites that use rendering services, the animal disposal plan also must include the name, address, and phone number of the renderer.
(v)It must be updated as animal disposal practices are changed at the site.
(vi)It must be signed and dated by the producer, as well as the caretaker of the site (if the caretaker is a different person than the producer).
(vii)It may be valid for a period no longer than 2 years after the date of signature by the producer and (if applicable) the site caretaker.
(2)*Animal movement record.* The animal movement record must meet the following minimum requirements:
(i)It must be filled out completely and properly, accounting for the movement of all non-breeding swine into and from the pork production site.
(ii)In the case of non-breeding swine coming into the site, it must include the date and number of arriving animals, as well as the TIN of the certified production site where the animals originated, or alternatively, if the swine are less than 5 weeks of age and originated from a noncertified site, the name and full address of the noncertified site where the animals originated. The animal movement record must clearly document that all non-breeding swine 5 weeks of age or older arriving at the site originated from another certified production site.
(iii)In the case of non-breeding swine leaving the site, it must include the date and number of departing animals, and their destination.
(iv)It must document the number of dead non-breeding swine that are removed from the site, as well as the number of dead non-breeding swine that are buried or composted at the site, if swine burial or composting is permitted in that State or locality.
(v)All entries to the animal movement record must be signed or initialed and dated by the producer or other site caretaker making the entry.
(3)*Rodent control logbook.* The rodent control logbook, which may include records from a pest control operator, must meet the following minimum requirements:
(i)It must include a rodent control diagram for the site indicating the location of all rodent bait stations and rodent traps at the site. The diagram must be updated whenever bait stations are added, moved, or removed.
(ii)It must document the number of rodent traps set (if applicable), the number of new rodent bait stations set, and how often bait is refreshed.
(iii)It must document the disposal method for all unused bait that is replaced.
(iv)It must document the brand name and active ingredient of bait, which must be EPA registered and applied according to its label, as well as the quantity of bait used (number of pounds).
(v)If possible, it should document the number of rodents caught or killed and indicate how many were rats.
(vi)If possible, it should document the number of rats sighted monthly.
(vii)All entries to the rodent control logbook must be signed or initialed, as well as dated by the producer or other site caretaker making the entry. It must be updated at least monthly.
(4)*Feed mill quality assurance affidavit.* The feed mill quality assurance affidavit, to be used in conjunction with feed or feed ingredients delivered to the pork production site, must meet the following minimum requirements:
(i)It must include the name of the producer and the identity of the site, including the TIN if it has been issued, and the site address, as well as the name and address of the feed mill and the name and title of the feed mill representative.
(ii)It must provide that the feed mill is following good manufacturing practices, and further specify, as evidence of these good manufacturing practices, the following:
(A)That the feed mill has a rodent control system that is maintained by the feed mill itself or by a pest control firm (include name and address of pest control firm).
(B)The frequency with which such rodent control system is maintained ( *i.e.* , on a weekly basis, etc.); and
(C)That the feed mill maintains records of pest management practices or has records generated by a pest control operator, which must be made available to the producer upon request.
(iii)It must be signed by the feed mill representative and by the producer or the producer's designated representative, to remain in effect for a period of 2 years.
(5)*Waste feeding logbook.* If the producer feeds meat-containing food waste to swine at the site, the producer must maintain a waste feeding logbook that meets the following minimum requirements:
(i)It must include the name of the producer and the identity of the site, including the TIN if it has been issued, the site address, and the number of the license or permit authorizing the feeding of such waste to swine.
(ii)It must be kept up-to-date with documentation evidencing adherence to applicable State and Federal food waste feeding laws and regulations.
(iii)It must provide information as to the method used in cooking the meat-containing food waste.
(iv)For each batch of meat-containing food waste cooked, it must record the batch number (if applicable to the operation), the temperature at which such food waste is cooked and the length of time it is held at that temperature, and the method for verifying the temperature and length of time cooked.
(v)For each batch of meat-containing food waste cooked, it must document the sources of meat.
(vi)It must evaluate and document on at least a monthly basis the level of sanitation of the site, taking into account the following factors:
(A)Whether garbage containers are clean and covered with lids;
(B)Sanitation of cooking area and equipment;
(C)Sanitation of feeding areas and waste disposal;
(D)Sanitation of storage areas;
(E)Rodent control system around equipment, storage, and feeding areas;
(F)Sanitation of waste hauling trucks or containers;
(G)Access of other animal species to food waste (wild animals, dogs, cats, etc.); and
(H)The potential for cross-contamination between cooked product and raw meat-containing food waste.
(vii)All entries to the waste feeding logbook must be signed or initialed, as well as dated, by the producer or other site caretaker making the entry.
(b)All such records and other documentation required under this section must be retained at the pork production site for a period of 2 years.
(c)All such records and other documentation required under this section must be readily available for inspection at the pork production site at the time of an audit by a QAV or QVMO, or by other APHIS representatives during normal business hours. § 149.8 Program fees and charges.
(a)*Site audit.* The producer is responsible for the cost of each site audit performed at the pork production site.
(1)If a QAV performs the site audit, then the producer will pay the QAV directly at a mutually agreed-upon time and rate.
(2)If a QVMO performs the site audit, then the producer will pay the QVMO at the time the site audit is performed in accordance with the rate and other conditions set by the QVMO's governmental employer. Further, if the QVMO who performs the site audit is employed by APHIS, then the producer will pay APHIS for this service at the hourly rate listed in table 2 for each employee required to perform the service. If the APHIS-employed QVMO performs the site audit on a Sunday, on a holiday, or at any time outside the normal tour of duty of that employee, then the producer will pay APHIS for this service at the hourly rate listed in table 3 for each employee required to perform the service. Payment to APHIS for the services of an APHIS-employed QVMO, by certified check or U.S. money order, must be remitted to the QVMO at the time the site audit is performed. Table 2.—Rates for Services of QVMO Beginning Oct. 1, 2003 Hourly rate: Per hour $84.00 Per quarter hour 21.00 Per service minimum fee 25.00 Table 3.—Overtime Rates for Services of QVMO (Outside The Employee's Normal Tour of Duty) Beginning Oct. 1, 2003 Premium hourly rate Monday through Saturday and holidays: Per hour $100.00 Per quarter hour 25.00 Premium hourly rate for Sundays: Per hour 112.00 Per quarter hour 28.00
(b)*Program fee.* The producer must pay APHIS a program fee at the time of each site audit in the amount of $51 to cover APHIS' administrative costs in processing the audit and operating the program. This program fee, payable to APHIS by certified check or U.S. money order, is due at the time of submitting the completed site audit form for APHIS evaluation.
(c)A producer will not be charged for the cost of having a spot audit performed at the pork production site. § 149.9 Pilot program sites. Pork production sites participating in an APHIS-approved trichinae pilot program at the time of implementation of the Trichinae Certification Program on [ *effective date of final rule* ] will maintain their same program status as either a Stage I enrolled, Stage II certified, or Stage III certified site, as well as their same program anniversary date for purposes of completing a site audit and submitting the completed audit form and payment. PART 160—DEFINITION OF TERMS 3. The authority citation for part 160 would continue to read as follows: Authority: 7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 371.4. 4. In § 160.1, a new definition would be added, in alphabetical order, for *qualified accredited veterinarian (QAV)* to read as follows: § 160.1 Definitions. *Qualified accredited veterinarian (QAV).* An accredited veterinarian who has been granted an accreditation specialization by the Administrator pursuant to § 161.5 of this subchapter based on completion of an APHIS-approved orientation or training program. PART 161—REQUIREMENTS AND STANDARDS FOR ACCREDITED VETERINARIANS AND SUSPENSION OR REVOCATION OF SUCH ACCREDITATION 5. The authority citation for part 161 would continue to read as follows: Authority: 7 U.S.C. 8301-8317; 15 U.S.C. 1828; 7 CFR 2.22, 2.80, and 371.4. 6. Section 161.5 would be added to read as follows: § 161.5 Specialization. An accreditation specialization recognized by the Administrator may be granted to an accredited veterinarian upon completion of an orientation or training program approved by APHIS. For certain accredited specializations, the cost of orientation or training may be borne by the accredited veterinarian. An accredited veterinarian granted an accreditation specialization will be referred to as a qualified accredited veterinarian or QAV. A QAV will be authorized to perform those activities and functions specifically provided for elsewhere in this chapter, for example, in part 149. 1 1 For further information on accreditation specializations, including training requirements and fees, contact the National Veterinary Accreditation Program, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737, phone
(301)734-6188. Done in Washington, DC, this 7th day of May 2007. Bruce Knight, Under Secretary for Marketing and Regulatory Programs. [FR Doc. E7-9236 Filed 5-15-07; 8:45 am] BILLING CODE 3410-34-P 72 94 Wednesday, May 16, 2007 Rules and Regulations Part VII Federal Communications Commission 47 CFR Parts 1, 20, 27, and 90 Service Rules for the 698-806 MHz Band and Revision of the Commission's Rules Regarding Enhanced 911 Emergency Calling Systems, Hearing Aid-Compatible Telephones, and Public Safety Spectrum Requirements; Final Rule FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1, 20, 27, and 90 [WT Docket No. 06-150; CC Docket No. 94-102; WT Docket No. 01-309; WT Docket No. 03-264; WT Docket No. 06-169; PS Docket No. 06-229; WT Docket No. 96-86; FCC No. 07-72] Service Rules for the 698-806 MHz Band and Revision of the Commission's Rules Regarding Enhanced 911 Emergency Calling Systems, Hearing Aid-Compatible Telephones, and Public Safety Spectrum Requirements AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In this document, the Federal Communications Commission
(FCC)adopts final rules governing wireless licenses in the 698-806 MHz Band ( *i.e.* , the 700 MHz Band). This spectrum is currently occupied by television broadcasters and is being made available for wireless services, including public safety and commercial services, as a result of the digital television (“DTV”) transition. DATES: Effective May 16, 2007, except for the amendments to §§ 20.18(a), 27.50(c)(5), and 27.50(c)(8) which contain information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the **Federal Register** announcing the effective date. ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Paul Moon at
(202)418-1793, *paul.moon@fcc.gov,* Mobility Division, Wireless Telecommunications Bureau; Paul D'Ari at
(202)418-1550, *paul.dari@fcc.gov,* Spectrum and Competition Policy Division, Wireless Telecommunications Bureau; John Evanoff at
(202)418-0848, *john.evanoff@fcc.gov,* Public Safety and Homeland Security Bureau. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report and Order, WT Docket No. 06-150; CC Docket No. 94-102; WT Docket No. 01-309; WT Docket No. 03-264; WT Docket No. 06-169; PS Docket No. 06-229; WT Docket No. 96-86, FCC No. 07-72, adopted April 25, 2007 and released April 27, 2007. The full text of the Report and Order is available for public inspection on the Commission's Internet site at *http://www.fcc.gov* . It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone
(202)488-5300; fax
(202)488-5563; e-mail *FCC@BCPIWEB.COM* . Final Paperwork Reduction Act of 1995 Analysis The Report and Order contains modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget
(OMB)for review under § 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. Public and agency comments are due sixty days from publication of a summary of the Report and Order in the **Federal Register** . Comments should address the following:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility;
(b)the accuracy of the Commission's burden estimates;
(c)ways to enhance the quality, utility, and clarity of the information collected; and
(d)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, *see* 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” In this present document, we have assessed the potential effects of the various policy changes with regard to information collection burdens on small business concerns, and find that there are no results specific to businesses with fewer than 25 employees. We note that the information collections contained in § 20.18(j)(4) are a result of the amendments to § 20.18(a). We also note that § 213 of the Consolidated Appropriations Act 2000 provides that rules governing frequencies in the 746-806 MHz Band become effective immediately upon publication in the **Federal Register** without regard to certain sections of the Paperwork Reduction Act. 1 The Commission is therefore not inviting comment on any information collections that concern frequencies in the 746-806 MHz Band. 1 In particular, this exemption extends to the requirements imposed by Chapter 6 of Title 5, United States Code, Section 3 of the Small Business Act (15 U.S.C. 632) and Sections 3507 and 3512 of Title 44, United States Code. Consolidated Appropriations Act 2000, Pub. L. No. 106-113, 113 Stat. 2502, Appendix E, Sec. 213(a)(4)(A)-(B); *see* 145 Cong. Rec. H12493-94 (Nov. 17, 1999); 47 U.S.C.A. 337 note at Sec. 213(a)(4)(A)-(B). Synopsis 1. In this Report and Order, the Commission addresses rules governing wireless licenses in the 698-806 MHz Band ( *i.e.* , the 700 MHz Band). This spectrum currently is occupied by television broadcasters in TV Channels 52-69 and is being made available for wireless services, including public safety and commercial services, as a result of the digital television
(DTV)transition. The Commission has been considering rules related to the use of this spectrum in three ongoing proceedings:
(1)The 700 MHz Commercial Services proceeding, 2
(2)the 700 MHz Guard Bands proceeding, 3 and
(3)the 700 MHz Public Safety proceeding. 4 Because decisions on certain issues in the three proceedings are potentially interrelated, the three proceedings are being jointly addressed in the Report and Order. In doing so, the Commission seeks to promote access to 700 MHz Band spectrum and the provision of service to consumers across the county, including in rural areas, as well as opportunities for broadband service for Public Safety users. 2 *See* Service Rules for the 698-749, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, and § 68.4(a) of the Commission's Rules Governing Hearing Aid-Compatible Telephones, WT Docket No. 01-309, *Notice of Proposed Rule Making, Fourth Further Notice of Proposed Rule Making, and Second Further Notice of Proposed Rule Making,* 21 FCC Rcd 9345 (2006). 3 *See* Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's Rules, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket Nos. 06-169 and 96-86, *Notice of Proposed Rule Making,* 21 FCC Rcd 10413 (2006). 4 *See* Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, PS Docket 06-229, WT Docket No. 96-86, *Ninth Notice of Proposed Rule Making,* 21 FCC Rcd 14837 (2006); Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, *Eighth Notice of Proposed Rulemaking,* WT Docket Nos. 96-86 and 05-157, 21 FCC Rcd 3668 (2006). A. 700 MHz Commercial Services 1. Facilitating Access to Spectrum and Provision of Service to Consumers
(i)Mix of Geographic Service Area Sizes 2. The FCC finds that providing for a mix of geographic licensing areas in the 700 MHz Band will balance the demand for differently sized licenses demonstrated in the record and enhance access to the spectrum by a variety of potential licensees. In particular, the FCC determines to replace the unassigned Economic Area Groupings (EAGs)-sized license areas, as established in the current band plan, with a mix of geographic licensing areas consisting of Cellular Market Areas (CMAs), Economic Areas (EAs), and Regional Economic Area Groupings (REAGs). These revisions are consistent with the goal of providing greater access to spectrum for small providers and parties in rural areas, and improving the opportunity for a wider range of potential licensees to obtain access to this valuable spectrum. 3. In determining the size of service areas, the FCC has stated as a general principle that it will consider licensing the spectrum over a range of various sized geographic areas, including smaller service areas such as CMAs, where consistent with the record in that proceeding and with other factors that may be relevant to the spectrum. Many commenters, including small and regional service providers and entities that represent rural interests, favor an approach that would provide for a variety of license sizes beyond those in the current band plan. The FCC agrees with those commenters who observe that a revised mix of smaller license sizes would provide a more balanced set of initial licensing opportunities at this time and make available more licenses to match the needs of different potential users. The opportunities afforded by providing licenses with a mix of geographic areas were seen in the results of Auction No. 66 involving Advanced Wireless Services (AWS)-1 licenses, where many different bidders won smaller and mid-sized licenses, such as CMAs and EAs. The same policy of providing a mix of licenses that balances competing interests is appropriate here. These revisions will advance the FCC's statutorily directed goals to promote service to rural areas, promote investment in and the rapid deployment of new technologies and services, avoid the excessive concentration of licenses, and provide for the dissemination of licenses among a wide variety of applicants. 4. The FCC concludes that providing a mix of CMA, EA, and REAG licenses in the 700 MHz Commercial Services spectrum will be an effective means of providing increased access to spectrum, especially in rural areas, while simultaneously meeting other Commission goals. The FCC disagrees with commenters who argue that any changes to smaller area licenses should be limited to the Upper 700 MHz Commercial Services Band, and not be implemented in the Lower 700 MHz Band. 5. Consistent with its earlier findings with respect to license sizes in the Upper and Lower 700 MHz Bands, the FCC declines to adopt nationwide licensing for any of the 700 MHz Commercial Services spectrum blocks. It also declines to adopt service areas smaller than CMAs, such as county-sized areas, or other size areas, including Major Economic Areas (MEAs). Because the band plan for the 700 MHz Commercial Services Band no longer contains EAGs, for the EAs, REAGs, and CMAs the FCC will separately license the Gulf of Mexico with each of the following license divisions: EA licensing area 176; REAG licensing area 12; and Metropolitan Statistical Area
(MSA)licensing area 306. The FCC adopts:
(i)The same definition of EAs set forth in § 27.6(h) of the rules, currently applicable for AWS-1 spectrum, for EA licenses in the 700 MHz Commercial Services Band;
(ii)the same definition of REAGs set forth in § 27.6(h) of the rules, currently applicable for AWS-1 spectrum, for REAG licenses; and
(iii)the same definition of Metropolitan Statistical Areas and Rural Service Areas (MSAs/RSAs) set forth in § 27.6(c), currently applicable to Block C of the Lower 700 MHz Band, for CMAs. As the FCC has done in licensing other part 27 services, the Gulf of Mexico service area is comprised of the water area of the Gulf of Mexico starting 12 nautical miles from the U.S. Gulf coast and extending outward.
(ii)Secondary Markets 6. The FCC declines to adopt rules that would require 700 MHz Commercial Services Band licensees to make “good faith” efforts to negotiate with potential spectrum lessees, either as part of their performance requirements or as part of the criteria associated with license renewal. The FCC believes that such changes are unnecessary given the other measures it is adopting to promote access to spectrum in the 700 MHz Commercial Services Band. These measures involve revising the 700 MHz Commercial Services band plan to include a mix of smaller geographic licensing areas. 7. Most commenters support a decision not to impose a “good faith” negotiation obligation on the 700 MHz Commercial Services Band licensees. Some of these commenters argue that such a requirement would be unnecessarily burdensome and could lead to uneconomic decisions. Commenters supporting the adoption of a “good faith” requirement argue that the FCC should consider a licensee's secondary markets participation as part of its license renewal process. The FCC notes, however, that its current spectrum leasing rules already provide a licensee with significant incentives to enter into spectrum leasing arrangements because licensees may rely on the activities of its spectrum lessee(s) for purposes of complying with the licensee's construction requirements. The FCC concludes that its decision to adopt a mix of geographic license area sizes, combined with our existing secondary markets rules, are sufficient to promote access to spectrum. Accordingly, the FCC declines to adopt further secondary markets requirements at this time. 2. Auctions-Related Issues
(i)Aggregating Licenses 8. The FCC concludes that the public interest would be better served by relying on the existing secondary market to aggregate existing and new licenses rather than attempting to develop new rules and policies for incorporating existing 700 MHz Commercial Services licenses into an auction of new licenses. Parties bidding on new licenses should be able to accurately value those licenses, even absent an opportunity to simultaneously aggregate new with existing licenses. New licenses in the 700 MHz Commercial Services spectrum can be used independently of existing licenses. Applicants will be able to seek any of multiple new licenses, of varying geographic size, to serve any given location. Thus, the value of the new licenses is unlikely to depend significantly upon a party's ability to aggregate existing and new licenses. Moreover, the interests of aggregators are likely to be met in large part by the existing secondary market. Accordingly, the FCC concludes that no new rules or policies are needed to facilitate aggregation of existing and new 700 MHz Commercial Services licenses in order to increase the likelihood that these licenses will be assigned to the parties most likely to put them to their most effective use.
(ii)Bidding Preferences 9. The FCC rejects the suggestions of certain commenters that it set aside licenses in the 700 MHz Commercial Services Band auction solely for designated entities and the argument that the FCC adopt a third small business definition to provide for a 35% bidding credit. Consistent with the FCC's tentative conclusion not to adopt Access Spectrum *et al.* 's band plan proposal and in light of various difficulties in implementing such a bidding credit, the FCC also does not adopt a bidding credit based on providing access to spectrum for 700 MHz public safety services. 10. Although the Communications Act requires that the FCC ensure that “designated entities” are given the opportunity to participate in the provision of spectrum-based services and, for such purposes, consider the use of bidding preferences, these preferences can take many forms. In an early attempt to meet these mandates, the FCC set aside blocks of spectrum in the Broadband PCS band to be held by designated entities. The FCC's experience in Broadband PCS auctions and subsequent auctions has demonstrated, however, that bidding credits for designated entities afford such entities substantial opportunity to compete with larger businesses for spectrum licenses and provide spectrum-based services. For example, Auction No. 66 demonstrated very recently that designated entities can succeed in auctions for licenses for valuable spectrum without any set-asides. In Auction No. 66, more than half the winning bidders were designated entities that received discounts on their gross winning bids and designated entities won over twenty percent of the licenses sold. Moreover, setting aside licenses risks denying the licenses to other applicants that may be more likely to use them effectively or efficiently for the benefit of consumers. Potentially excluding such applicants could compromise the FCC's pursuit of various statutory objectives including promoting the development and deployment of new technologies, products, and services for the benefit of the public and promoting efficient and intensive use of the spectrum.
(iii)Competitive Bidding and Aggregating New Licenses 11. The FCC's current competitive bidding rules authorize the use of package bidding and the FCC already has utilized a form of package bidding. Consequently, the question before the FCC now is whether it needs to make changes to our competitive bidding rules in order to enable a new form of package bidding for the 700 MHz Commercial Services auction. The FCC concludes that modifications to our current bidding systems, including those suggested by commenters, can be made without modifying its competitive bidding rules.
(iv)Modifications to the Tribal Land Bidding Credit 12. No parties provided suggestions for possible modifications to the FCC's tribal land bidding credit rules to promote the deployment of wireless services to tribal lands or addressed the relationship between post-auction credits and the deadline for depositing payments. In light of the record, the FCC concludes that it need not modify the tribal land bidding credit at this time. 3. Additional Rules for Licensees
(i)Criteria for Renewal 13. The FCC clarifies that all licensees in the 700 MHz Commercial Services Band seeking renewal of their authorizations at the end of their license term must file a renewal application in accordance with the provisions of § 1.949 of the FCC's rules. Consistent with existing rules, as part of this renewal requirement licensees must demonstrate in their applications that they have provided substantial service during their past license term, which is defined as service that is sound, favorable, and substantially above a level of mediocre service that just might minimally warrant renewal. This requirement is distinct from performance requirements. Substantial service in the renewal context, as opposed to coverage benchmarks established for the performance requirement context, encompasses FCC consideration of a variety of factors including the level and quality of service, whether service was ever interrupted or discontinued, whether service has been provided to rural areas, and any other factors associated with a licensee's level of service to the public. Accordingly, a licensee that meets the applicable performance requirements might nevertheless fail to meet the substantial service standard at renewal. Licensees must demonstrate at renewal that they have substantially complied with all applicable FCC rules, policies, and the Communications Act of 1934, as amended, including any applicable performance requirements. 14. Under the revised § 27.14 of the FCC's rules, the FCC also is eliminating the filing of competing applications to requests for renewal of these 700 MHz licenses. The FCC is mindful of the potential costs and the burdens they impose on both it and licensees. The FCC agrees with comments that such administrative processes “harken[ ] back to an old era * * * where competitors were known to file ‘strike’ applications against a renewal in the hope of getting a payoff.” Under the revised § 27.14 of the FCC's rules, the FCC is therefore adopting a process by which 700 MHz Commercial Services Band licenses come back to the FCC for re-auction if a license is not renewed. The existing petition to deny process, coupled with the ability of a petitioner to participate in any subsequent auction to re-license spectrum that is returned to the FCC for lack of renewal, creates sufficient incentives to challenge inferior service or poor qualifications of licensees at renewal. This approach protects the public interest without creating incentives for speculators to file “strike” applications. 15. By eliminating the filing of competing applications at renewal, the FCC finds that the concerns raised by the majority of commenters in this proceeding about renewal expectancies are moot. The FCC recognizes that the majority of commenters that addressed renewal issues did not support any changes to the part 27 renewal rules applicable to 700 MHz Commercial Services Band licensees. Moreover, some of these commenters expressed concern that any revision to the rules governing renewal proceedings would eliminate the concept of “renewal expectancy” that applied in comparative hearings. Because smaller carriers and rural interests in particular seemed concerned that certain rule changes would place a new burden on carriers ill-equipped to meet it, we have decided to maintain 700 MHz Commercial Services Band licensees' expectations of renewal by eliminating provisions for competing applications. This action provides additional certainty for all 700 MHz Commercial Services Band licensees, and requests by certain commenters to do otherwise could result in additional administrative burdens on licensees that we find not to be in the public interest.
(ii)License Terms 16. The FCC revises its rules to provide that initial authorizations for the 700 MHz Commercial Services Band will have a term not to exceed 10 years from February 17, 2009, which is the firm deadline for the DTV transition. Subsequent renewals will be for terms not to exceed 10 years. This revised license term will apply to all licenses in the 700 MHz Commercial Services Band. However, because § 307(c)(1) of the Communications Act provides that a license for operating a broadcast station shall not be granted for a term that exceeds 8 years, the FCC retains the current provision that a part 27 licensee commencing broadcast services will be required to seek renewal of its license for such services at the termination of the eight-year term following commencement of such operations. The FCC does not revise the license term for Guard Band licensees because such revisions fall beyond the scope of the 700 MHz Commercial Services proceeding. 17. The FCC is extending the revised license term to both the already auctioned and unauctioned licenses in the 700 MHz Commercial Services Band. The FCC finds that uniformly extending the license term in this manner provides a level of parity for services within the same band. In addition, this treatment recognizes that band clearing and the resulting unencumbered use of the spectrum in the pre-DTV Act period was tied to a transition scheme that has now been replaced with a firm statutory transition date of February 17, 2009. Specifically, the underlying reason behind the current rule changed with passage of the DTV Act. The FCC previously determined that a definite termination date, *e.g.* , January 1, 2015, was preferable to a discrete term of years following the end of the DTV transition, which at that time was subject to extension on a market-by market basis. The same license terms that were adopted in the *Upper 700 MHz First Report and Order* were applied to licenses in the Lower 700 MHz Band. However, the DTV Act's uniform deadline for the DTV transition has effectively removed the issue of market-by-market broadcast incumbency. Under these circumstances, the FCC provides a level of uniformity by extending the revised license terms to all licensees in the 700 MHz Commercial Services Band, except for those engaging in broadcast services. 18. The FCC finds that a term not to exceed 10 years from February 17, 2009, should be used for initial authorizations in the 700 MHz Commercial Services Band, and that subsequent renewal terms will be 10 years. A ten-year license term is consistent with most other part 27 services, with the exception of recently auctioned AWS-1 licenses, which we address below, as well as with the license terms for other similar spectrum, such as that used for cellular service and PCS. In addition, this period will offer licensees regulatory certainty and help promote investment in the band. Under the current rules, all licensees would have terms that extend until January 1, 2015, which is only approximately six years from the end of the DTV transition. Thus, licensees that acquire their authorizations in a future auction would have had an initial license term less than ten years, and more likely for a shorter period, *i.e.* , six or seven years, depending on the date of the auction and issuance of the authorizations. In similar fashion, current licensees in the 700 MHz Commercial Services Band would only have approximately six years of access to their spectrum free from broadcasters. The FCC finds that a longer period should be made available to all licensees in order to provide sufficient time for the recovery of costs related to the development and deployment of new services, especially those based on technologies that are more advanced, more expensive, and which may take longer to develop. The 700 MHz Commercial Services Band is a likely band for the use of these more advanced technologies and we are concerned that a license term that expires only six years from the DTV transition provides too short a time period. 19. The FCC declines to increase the length of initial or renewal terms to fifteen years. The FCC disagrees with those commenters who argue that parity with AWS-1 services mandates a fifteen-year term for 700 MHz services. The “relocation and band clearance issues” that provided the rationale for the fifteen-year initial licenses for AWS-1 services do not apply here. The date certain of February 17, 2009, for the end of the DTV transition means that spectrum in the 700 MHz Band will be clear for use by 700 MHz Band licensees as of that date. 20. The FCC also disagrees with commenters who argue that the current license term should be retained in order to promote prompt use of the spectrum and with commenters who argue that the current rule should be kept to spur the development of a secondary market. The combination of the FCC decisions in this Report and Order and the FCC's secondary markets policies make it unlikely that this highly valued spectrum will sit unused. The FCC's secondary market spectrum leasing policies focus on promoting spectrum leasing arrangements, and the FCC has taken steps in this Report and Order to improve use of the spectrum, including the provision of a mix of geographic license areas consisting of CMAs, EAs, and REAGs. 21. Finally, because of the specifically applicable statutory limitation, the FCC will retain the current requirement that 700 MHz Commercial Services Band licensees commencing broadcast services will be required to seek renewal of their licenses for such services prior to the termination of the eight-year term following commencement of such operations. As stated above, § 307(c)(1) of the Communications Act provides that licenses granted for operating broadcast stations “shall be for a term not to exceed 8 years.”
(iii)Power Limits for Lower 700 MHz Band and Upper 700 MHz Commercial Services Band Base Stations 22. The FCC modifies its power limit rules for the Lower 700 MHz Band and the Upper 700 MHz Commercial Services Band in a number of ways. First, the FCC implements a PSD model for defining power limits for base stations operating in the entire 700 MHz Commercial Services Band. The current power limit rules do not specify a bandwidth over which a licensee's power is to be limited, and could be construed to mean that the power limit applies on a “per emission” basis. Because some licensees may only transmit one emission within their given bandwidth, while others using technologies with narrower emissions might employ multiple emissions over that bandwidth, construing the power limit to apply on a “per emission” basis could allow licensees employing multiple emissions to transmit more total energy in their authorized spectrum blocks than licensees with only one emission in their spectrum blocks. To better accommodate all technologies, the FCC is clarifying that the maximum allowable power levels in the 700 MHz Commercial Services Band are to be defined on a “per megahertz of spectrum bandwidth” basis, rather than on a “per emission” basis. This clarification will enable higher power signals from wider band technologies, but will not result in a decrease in the total power currently allowed in the band from narrower band technologies. Given this clarification, the FCC is also adopting additional measures to protect against any possible increased risk of interference, especially to 700 MHz public safety users. 23. More specifically, the FCC will allow 700 MHz Commercial Services Band licensees employing bandwidths greater than 1 megahertz to meet a base station power limit of 1 kW/MHz ERP ( *i.e.* , no more than 1 kW ERP in any 1 megahertz band segment). Licensees operating with bandwidths of less than one megahertz will, however, continue to be permitted to operate at power levels up to 1 kW ERP over their bandwidth. Thus, for example, a licensee transmitting a signal with a bandwidth of 5 megahertz could employ a power level of 5 kW ERP over the 5 megahertz bandwidth, with each 1 megahertz band segment within the 5 megahertz bandwidth being limited to 1 kW ERP; and a licensee transmitting a signal with a bandwidth of 200 kilohertz could employ a power level of 1 kW ERP over the 200 kilohertz bandwidth. This approach to defining power limits will achieve a degree of technological neutrality by ensuring that all licensees regardless of technology choice have enough power to operate a viable service. This neutrality would not exist if all licensees, regardless of their operating bandwidth, were required to limit their base station power levels to 1 kW ERP per emission. 24. In response to proposals by parties seeking greater power limits for rural area operations, the FCC will permit power levels of up to 2 kW/MHz ERP in rural areas, and consistent with its decision above, the FCC will allow rural licensees operating with bandwidths less than one megahertz to operate at power levels up to 2 kW ERP over their bandwidth. In implementing this decision, the FCC will define rural areas, consistent with the *Rural Report and Order* , as those counties in the U.S. having a population of fewer than 100 people per square mile, based on the most recently available population statistics from the Bureau of the Census. Increasing the permissible power in rural areas will enable 700 MHz Commercial Services Band licensees operating in such areas to more easily implement their systems; and increasing power levels in rural areas would be consistent with the recent FCC decision to permit rural carriers in the Cellular, AWS, and Broadband PCS services to operate at higher power levels. The FCC notes that in the *Rural Report and Order* , where the same power increase was adopted, it decided, as a “cautionary measure,” to require carriers operating at higher power levels to coordinate with licensees operating within 75 miles of their base stations. Consistent with this decision, the FCC shall require any 700 MHz Commercial Services Band licensee seeking to operate a base station under our rules permitting power levels greater than 1 kW ERP in rural areas to coordinate in advance with all non-public safety 700 MHz licensees authorized to operate within 75 miles of the station and with all 700 MHz Regional Planning Committees that have jurisdiction within 75 miles of the station. 25. As noted above, licensees in the Lower 700 MHz Band are allowed to use up to 50 kW ERP if they do not produce signals exceeding a power flux density
(PFD)of 3 mW/m 2 on the ground within 1 kilometer of the station. A number of commenters expressed views on the appropriateness of the current, maximum 50 kW ERP capability for Lower 700 MHz Band operations. Considering these comments, the FCC makes certain modifications to the power limit rules in the Lower 700 MHz Band. Specifically, the FCC will retain the ability of incumbent C and D Block licensees to employ power levels up to 50 kW ERP. In addition, because the FCC believes that unpaired blocks are conducive to the provision of broadcast-type operations, it shall permit licensees operating in any unpaired block(s) in the Lower 700 MHz Band to operate at a power level of 50 kW ERP as well. However, because the FCC believes that paired blocks are generally more conducive to the provision of mobile services, it shall not extend to new licensees operating in any Lower 700 MHz Band paired blocks the ability to operate at 50 kW ERP. This action helps preserve the flexibility the FCC originally envisioned for the Lower 700 MHz Band, *i.e.* , the use of both broadcast and mobile services in the band, by providing an environment conducive to mobile systems in the paired blocks and an environment conducive to broadcast-type systems in the unpaired blocks. Current and future licensees nevertheless will have the flexibility to implement broadcast-type or mobile systems in any particular block. For example, a licensee may implement a broadcast-type system in a paired block, but rather than a high-power, high-site system, it would have to design a distributed broadcast system. 26. In reaching this decision, the FCC concludes that it would not be appropriate to reduce the power limits of incumbent Lower 700 MHz Band licensees, who acquired their spectrum with the expectation that they would be able to employ 50 kW ERP transmissions in the band. Although the FCC recognizes concerns expressed by certain parties regarding the potential for adjacent band interference into the current unauctioned paired blocks ( *i.e.* , the current A and B Blocks) from high power emissions in adjacent incumbent and unauctioned unpaired blocks, the FCC continues to believe that our out-of-band emission limits coupled with the 3 mW/m 2 PFD requirement will be effective in protecting unauctioned paired blocks from adjacent channel interference. The FCC notes, however, that the 50 kW ERP limit in the Lower 700 MHz Band was based on a traditional broadcast emission, which consists of a single emission within the licensed bandwidth. The FCC never intended that emissions within a single block in the Lower 700 MHz Band exceed 50 kW ERP. Accordingly, the FCC clarifies that the 50 kW ERP limit for the current C and D Blocks, and any additional unpaired block(s) in the Lower 700 MHz Band, is a cap on the average total power of all emissions within the full authorized spectrum of the blocks. For example, a single incumbent C or D Block base station with an emission bandwidth of 1 megahertz could transmit with the full 50 kW ERP, but no other emissions would be permitted in the remaining 5 megahertz of the block. This limit would also apply to the cumulative emissions of both licensees if a 6 megahertz incumbent or unauctioned unpaired block is disaggregated. 27. In implementing this PSD approach to the power limits in both the Lower 700 MHz Band and the Upper 700 MHz Commercial Services Band, the FCC continues to remain concerned that transmissions at higher power levels could potentially cause interference to adjacent channel operations. To mitigate the potential for harmful interference to adjacent channel operations, the FCC requires the following. For Lower 700 MHz Band licensees, if operating with a bandwidth of 1 megahertz or less and a transmitting power greater than 1 kW ERP non-rural or 2 kW ERP rural, or if operating with a bandwidth of more than 1 megahertz and a PSD greater than 1 kW/MHz ERP non-rural or 2 kW/MHz ERP rural, then that licensee must comply with the 3 mW/m 2 PFD limit. Thus, for example, a non-rural licensee transmitting an 8 kW ERP signal in a 5-megahertz bandwidth or a rural licensee transmitting a 4 kW ERP signal in a 1.25 megahertz bandwidth would have to satisfy the 3 mW/m 2 PFD limit. However, a licensee transmitting an 800 watt ERP signal in a 200 kilohertz bandwidth or a 4 kW ERP signal in a 5-megahertz bandwidth, or a rural licensee transmitting an 8 kW ERP signal in a 5-megahertz bandwidth, would not have to meet the PFD limit. Because the FCC wishes to remain especially vigilant regarding the potential for interference to public safety operations, it impose the following additional requirement on Commercial Services licensees operating in the Upper 700 MHz Band. Specifically, all Upper 700 MHz Commercial Services Band licensees, both rural and non-rural, transmitting signals at a power levels greater than 1 kW ERP, irrespective of bandwidth, must satisfy the 3 mW/m 2 PFD limit. Thus, for example, an Upper 700 MHz Commercial Services Band licensee transmitting a 4 kW ERP signal in a 5-megahertz bandwidth would have to meet the PFD limit.
(iv)Power Limit Issues in WT Docket No. 03-264 28. The FCC will employ PSD for defining power limits in the 700 MHz Band. The FCC has thus granted the second of CTIA's requests as it applies to the 700 MHz Commercial Services Bands. However, the FCC shall not apply to the 700 MHz Band CTIA's proposal to double power limits in the PCS and AWS-1 bands— *i.e.* , a power increase that would apply in both rural and non-rural areas and would not be accompanied by a PFD limit. CTIA provides no justification for permitting an unrestricted doubling of power levels for the 700 MHz Commercial Services Bands, and the FCC finds no basis for adopting such limits for the band. Instead, as discussed above, the FCC is adopting rules for 700 MHz Band licensees that will allow for a power limit of 1 kW/MHz ERP in non-rural areas and 2 kW/MHz ERP in rural areas. 29. The FCC does, however, find merit in extending to the 700 MHz Commercial Services Band CTIA's proposal to use “average,” rather than “peak” power in measuring power levels. Although the use of “average” power will effectively result in an increase in 700 MHz Band power levels for non-constant envelope technologies, such as CDMA and WCDMA, the “average” measurement approach is a more accurate measure of the interference potential for these technologies. The FCC finds that any effective increase in power that would result through the use of an “average” measurement approach will be modest, and in any event will be outweighed by the benefit of measuring today's technologies using a more realistic and appropriate technique. 30. For purposes of clarifying the use of the “average power” measurement technique, the FCC makes the following determinations. First, the FCC concludes that the technique shall be made during a period of continuous transmission and be based on a measurement using a 1 megahertz resolution bandwidth. Second, the FCC shall restrict the peak-to-average (“PAR”) ratio of the radiated signal to 13 dB. Limiting the PAR to 13 dB strikes a balance between enabling licensees to use modulation schemes with high PARs (such as OFDM) and protecting other licensees from high PAR transmissions. Parties seeking to employ the “average power” measurement technique should consult with the FCC Laboratory for guidance on the appropriate averaging method for the particular technology they plan to use.
(v)Other Technical Issues 31. The FCC will retain the existing OOBE limits for commercial base stations operating in the Upper 700 MHz Commercial Services Band because it finds these restrictions provide sufficient and appropriate protection to 700 MHz public safety operations. The FCC also declines to impose any technical restrictions on Upper 700 MHz Commercial Services Band licensees to address potential IM interference to 700 MHz public safety operations. The FCC will, however, require Upper 700 MHz Commercial Services Band licensees and 700 MHz public safety entities, upon request from the other, to exchange information about their stations and systems. The FCC is adopting this requirement in order to limit the potential for IM interference to 700 MHz public safety mobile and portable devices from the transmissions of Upper 700 MHz Commercial Service Band base stations. 32. With regard to the argument for the need for increased OOBE limits, the conclusion that the FCC's 76 +10 log P OOBE limit will result in interference to 700 MHz public safety operations is based on the assumption of a 65 dB site isolation figure in analyzing potential interference between commercial base stations and public safety mobile/portable receivers. However, the FCC rejected this same premise in deciding not to adopt stricter OOBE limits in the *Upper 700 MHz Band Third MO&O* . In the *800 MHz Report and Order* , the FCC decided not adopt stricter OOBE limits to protect 800 MHz public safety operations. The FCC stated, as its rationale for not increasing the existing OOBE limit for the 800 MHz band, that the additional filtering needed to achieve proposed OOBE standards “would add cost and complexity—but no benefit—to those cells in a system in which, because of their location, or otherwise, unacceptable OOBE interference would not occur” and the FCC was therefore unwilling to “impose stronger OOBE limits on every cell of every system in the country; particularly if only a handful of cells in a system might require them.” The FCC continues to believe that any change to the OOBE limit required for commercial Upper 700 MHz Commercial Services Band base stations is unsupported.
(vi)911/E911 Requirements 33. The FCC concludes that § 20.18(a) should be amended to apply 911/E911 requirements to all commercial mobile radio services (CMRS), including services licensed in the 700 MHz Commercial Services Band and the AWS-1 bands, to the same extent as they apply to wireless services currently listed in the scope provision of § 20.18. Thus, CMRS providers must comply with the 911/E911 requirements solely to the extent that they “[offer] real-time, two way switched voice service that is interconnected with the public switched network and utilize an in-network-switching facility which enables the provider to reuse frequencies and accomplish seamless hand-offs of subscriber calls” (hereinafter, the “§ 20.18(a) criteria”). The FCC will continue, however, to exclude MSS from § 20.18 in conformity with the Commission's decision in the *E911 Scope Order* . 34. The public interest generally requires wireless services meeting the § 20.18(a) criteria to provide 911/E911 service, even if not expressly enumerated. The FCC has observed previously that “911 service is critical to our Nation's ability to respond to a host of crises,” and that E911 in particular “saves lives and property by helping emergency services personnel do their jobs more quickly and efficiently.” The FCC also takes note of Congress's finding in the Ensuring Needed Help Arrives Near Callers Employing 911 Act of 2004 (ENHANCE 911 Act) that “for the sake of our Nation's homeland security and public safety, a universal emergency telephone number
(911)that is enhanced with the most modern and state-of-the-art telecommunications capabilities possible should be available to all citizens in all regions of the Nation” and that “enhanced 911 is a high national priority.” Accordingly, it is critical that mobile telephone services meeting the § 20.18(a) criteria continue to offer 911 and E911 as they make use of new frequencies. 35. The FCC further finds that commercial mobile radio services meeting the 20.18(a) criteria will also meet the four criteria set forth in the *E911 Scope Order.* 5 In particular, the FCC finds that these services are likely to compete with services provided pursuant to cellular, broadband PCS, or 800/900 MHz SMR licenses, and that subscribers will have similar expectations of emergency access from services meeting the § 20.18(a) criteria regardless of what frequencies carriers are using to provide them. Indeed, the FCC has found that for many Americans, “the ability to call for help in an emergency is the principal reason they own a wireless phone.” This should be no less true for a consumer calling from a phone utilizing 700 MHz, AWS, or any other spectrum. Further, the FCC finds no support in the record, and consider it unlikely, that additional, terrestrial-based commercial mobile radio services meeting all of the criteria of § 20.18(a) will present any special technical obstacles, as compared to currently deployed services, that would warrant modifications of the 911/E911 requirements. To the extent that such obstacles become apparent as new services are established, appropriate modifications can be considered at that time. The FCC therefore agrees with the commenters that the extension of the 911/E911 requirements under § 20.18 to all commercial mobile radio services meeting the § 20.18(a) criteria is justified by the interest in competitive neutrality as well as by the critical public safety benefits of 911/E911. 5 Specifically, the Commission determined that it would consider whether
(1)the service offers real-time, two-way voice service that is interconnected to the pubic switched network on either a stand-alone basis or packaged with other telecommunications services;
(2)the customers using the service or device have a reasonable expectation of access to 911 and E911 services;
(3)the service competes with traditional CMRS or wireline local exchange service; and
(4)it is technically and operationally feasible for the service or device to support E911. *See* Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket 94-102, IB Docket No. 99-67, *Report and Order and Further Notice of Proposed Rulemaking* , 18 FCC Rcd 25340, 25347 ¶ 18
(2003)(“ *E911 Scope Order* ”).
(vii)Hearing Aid-Compatible Wireless Handsets 36. For reasons similar to those discussed in the E911 section above, the FCC determines that all digital CMRS providers, including providers of such services in the 700 MHz Commercial Services Band and the AWS-1 and BRS/EBS bands, should be subject to hearing aid compatibility requirements under § 20.19 to the extent they offer real-time, two-way switched voice or data service that is interconnected with the public switched network and utilizes an in-network switching facility that enables the provider to reuse frequencies and accomplish seamless hand-offs of subscriber calls. In addition, manufacturers of wireless handsets that are capable of providing such service also should be made subject to the applicable requirements of § 20.19. As discussed below, however, the existence of an established, applicable technical standard is a statutory requirement for imposing hearing aid compatibility requirements. Because no such standard currently exists for any services beyond the broadband PCS, Cellular, and certain SMR bands, the FCC cannot presently impose hearing aid compatibility requirements on additional services. The FCC does commit to bringing all digital CMRS within the scope of the § 20.19 requirements as appropriate technical standards are developed, and we take steps to promote the development of these technical standards, as discussed below. In particular, the FCC establishes a specific timetable for the development of the necessary technical standards for those new services that have governing service rules in place. The FCC amends the rule to reflect these determinations, including its decision that hearing aid compatibility requirements will apply to any CMRS to the extent that it meets the criteria discussed above and there is an established technical standard for hearing aid compatibility applicable to the relevant handsets. 37. Extending hearing aid compatibility requirements to services beyond those currently covered will ensure that comparable service providers and manufacturers will be required to comply with similar hearing aid-compatible handset requirements regardless of the frequency bands on which they operate. Further, end users will be able to expect the full range of functionality found today in mobile phones without having to know the technical details, such as the frequencies on which their phones operate. Moreover, by clarifying the applicability of the hearing aid compatibility rules to these manufacturers and service providers now, the FCC enables them to begin planning to incorporate hearing aid compatibility compliance into their operations at the earliest possible stage, which should also promote a more efficient implementation. The FCC also ensures that the necessary parties become involved in ongoing discussions among the Commission, service providers, standards bodies, and industry representatives to develop additional standards for hearing aid compatibility measurement methods and parametric requirements. 38. The FCC concludes that any CMRS digital service that meets the § 20.19(a) criteria for inclusion should be subject to hearing aid compatibility requirements. The FCC declines, however, to impose hearing aid compatibility obligations on other services and bands at this time. When the FCC imposed the existing hearing aid compatibility obligations on handset manufacturers and service providers in 2003, it simultaneously approved ANSI C63.19 as an established technical standard applicable to the services covered by the rule. Indeed, the FCC noted that the existence of an established technical standard was a statutory requirement for imposing hearing aid compatibility, and further found that this statutory requirement was “[f]undamental” to the determination of whether to impose hearing aid compatibility on wireless devices. The FCC therefore finds that an applicable technical standard should be in place when hearing aid compatibility obligations are imposed in the 700 MHz Commercial Services Band and other bands. 39. As noted above, none of the available versions of the current hearing aid compatibility standard cover services in the 700 MHz Commercial Services Band or the AWS-1 or BRS/EBS bands. Nor do they provide tests for some of the technologies anticipated in these bands, such as WiMAX. HIA argues that the ANSI C63.19-2006 standard for the 800 MHz band provides an appropriate framework to measure performance in the 700 MHz Band for purposes of determining hearing aid compatibility, but the record does not establish that the existing standard can be extended to that band without modifications or amendments. Indeed, HIA concedes that modifications to the standard may be necessary, and the Hearing Loss Association of America
(HLAA)also supports this conclusion, noting that changes to the standard will be necessary to accommodate emerging technologies. Accordingly, the FCC concludes that it cannot extend specific hearing aid compatibility obligations to emerging bands and services until specific standards that establish the hearing aid compatibility measurement methods and parametric requirements for these additional services' and bands' devices are developed. 40. The FCC will continue to monitor progress to make sure that the adoption of such standards proceeds in a timely manner. If no standards have been adopted within 24 months, the FCC will consider alternative means to implement compatibility requirements, including whether to develop new metrics for compliance entirely and/or whether to extend the C63.19-2006 standard for the 800 MHz Band into the 700 MHz Commercial Services Band, as HIA suggests. The FCC will not at this time establish a schedule for future action regarding bands other than the current 27.1(b) bands because it does not appear to be possible to develop compatibility standards in the absence of service rules. The FCC also notes that there is little or no discussion in the record of extending hearing aid compatibility beyond the 700 MHz Commercial Services Band. The FCC will, however, pursue appropriate action as the nature of services in new bands becomes more defined or we find that an applicable standard has been or can be developed. B. 700 MHz Guard Bands 41. The FCC replaces the Guard Band Manager regime in favor of the spectrum leasing policies and rules adopted in the Secondary Markets proceeding, and removes certain use and eligibility restrictions regarding licensee operations and leasing to affiliates to encourage the most effective and efficient use of the Guard Bands spectrum. While the FCC seeks to provide licensees and spectrum lessees with greater latitude and remove regulatory barriers where possible, it retains the existing Guard Band Manager coordination requirements. 1. Adoption of Secondary Markets Spectrum Leasing Rules 42. Among the FCC's key public interest objectives is to ensure that spectrum is put to its most efficient and effective use, and the FCC has increasingly granted technical and operational flexibility to its licensees to enable them to achieve that goal when it is consistent with preventing unacceptable interference. In adopting the Secondary Markets spectrum leasing policies and rules, the FCC accommodated the demand for significantly broader access to licensed spectrum by enabling a wide array of facilities-based providers to enter into spectrum leasing arrangements with spectrum users. These rules provided licensees with greater ability and incentive to make unused spectrum available to third parties, and thus promoted the provision of new and diverse services and applications. Third parties that could benefit from such spectrum leasing arrangements may include current spectrum operators requiring additional spectrum to meet customer needs over either the short-or long-term, new entrants seeking to provide a niche service and serve a limited area or narrowly targeted end-user market, small businesses trying to deliver services in rural communities, or entities unable or unwilling to participate in spectrum auctions or that otherwise do not have a license through which they can access spectrum to meet consumer or internal operational needs. By adopting the Secondary Markets spectrum leasing model, the FCC sought to establish spectrum leasing policies that allow licensees and spectrum lessees significant flexibility to enter into leasing arrangements that best meet their respective business needs and enable more efficient use of spectrum. 43. The FCC agrees with commenters that the Secondary Markets spectrum leasing model may be more effective than the existing band manager rules in accomplishing the Commission's goals of permitting the efficient and intensive use of spectrum while protecting public safety operations from harmful interference. Although the FCC sought to provide appropriate incentives to encourage greater participation in band manager leasing arrangements, the Guard Band Managers appear to have had limited success in negotiating spectrum user agreements with third parties. In contrast, the steadily increasing number of spectrum leasing arrangements in the other Wireless Radio Services reflects the growing use and acceptance of Secondary Markets spectrum leasing policies by wireless providers and spectrum lessees as an effective method to make spectrum more readily available to additional spectrum users. Since the Secondary Markets spectrum leasing procedures went into effect in February 2004, licensees and spectrum lessees have entered into approximately 1,200 spectrum leasing arrangements. 44. Accordingly, the FCC determines that providing Guard Bands licensees the additional flexibility offered by the Secondary Markets spectrum leasing regime would enhance spectrum usage in the 700 MHz Guard Bands. Specifically, in order to provide maximum flexibility, Guard Band licensees now will have the option of entering into both spectrum manager leasing and *de facto* transfer leasing arrangements. By permitting Guard Band licensees and spectrum lessees to choose between the two different options, the FCC will afford licensees and spectrum lessees significant flexibility to craft the type of leasing arrangement that best matches their particular needs and the demands of the marketplace. This flexibility could, in turn, help achieve fuller utilization of the spectrum. For example, adopting rules that permit Guard Band licensees to participate in *de facto* transfer leasing—in which primary responsibility for compliance with statutory and regulatory policies and rules is transferred from licensees to spectrum lessees—could encourage a licensee to enter into a leasing agreement that might otherwise be unattractive due to the level of operational oversight necessary to ensure compliance with the FCC's rules in a specific case. 45. The FCC emphasizes, however, that by affording 700 MHz Guard Band licensees greater flexibility, particularly in the *de facto* transfer leasing context, it is not minimizing in any way the requirement that these licensees must ensure that adjacent public safety operations are protected from harmful interference. Protection of 700 MHz public safety operations from interference remains the primary goal of the Commission's policies relating to the 700 MHz Guard Bands. The FCC agrees with comments that the Secondary Markets spectrum leasing rules provide sufficient mechanisms to ensure non-interference with spectrum users in the adjacent 700 MHz Public Safety Band. As noted by the BOP proponents, the Secondary Markets spectrum leasing rules provide protection equivalent to the band manager rules. 46. Although the FCC recognizes that the additional flexibility afforded by the *de facto* transfer spectrum leasing option transfers the primary responsibility for ensuring interference protection to the spectrum lessee, the FCC concludes that public safety users will still be protected from interference under the Secondary Markets spectrum leasing rules. Under this option, 700 MHz Guard Band licensees continue to retain some responsibility for operations encompassed under their license authorizations, and may be held responsible in cases of ongoing violation or other egregious lessee behavior for which licensees have, or should have, knowledge. More importantly, although the FCC expects Guard Band licensees to continue to exercise some oversight of its lessees, the Commission retains direct authority to pursue remedies against lessees under § 503(b) of the Act. Spectrum lessees, whether under a spectrum manager leasing arrangement or a *de facto* transfer leasing arrangement, must strictly comply with the technical restrictions of the band, and must expressly agree to comply with all applicable Commission rules as a condition of the spectrum leasing arrangement. Regardless of whether the licensee or spectrum lessee holds primary responsibility for compliance with FCC rules, the FCC maintains the ability to take direct and swift action to enforce compliance with its rules. 47. The FCC concludes that it should apply our Secondary Markets spectrum leasing rules to the 700 MHz Guard Bands service. By doing so, the FCC will facilitate more efficient use of the spectrum by licensees and spectrum lessees, and will produce a more market-driven system that should better meet the needs of the public without compromising the FCC's other core public interest goals—specifically, ensuring that public safety operations are protected from harmful interference. Although the FCC sought comment on whether we should permit licensees to choose between the existing Guard Band Managers regime or the Secondary Markets spectrum leasing rules, the FCC concludes that it is unnecessary to also allow licensees the ability to choose between the two leasing models, and thus replace the Guard Band Manager leasing regime with the Secondary Markets spectrum leasing policies and rules. Application of the Secondary Markets rules to all 700 MHz Guard Bands licensees will provide significant additional flexibility and ensure that these licensees are treated similarly to other Wireless Radio Services holding exclusive use licenses and leasing spectrum usage rights. 2. Use and Operational Flexibility 48. In addition to providing licensees and other spectrum users additional flexibility provided under our general Secondary Markets spectrum leasing rules, the FCC concludes that other changes to the 700 MHz Guard Bands rules should be made to promote more efficient and effective use of this spectrum. 49. *Band Manager Status.* In creating the 700 MHz Guard Bands service, the FCC designated Guard Band Managers as a new class of commercial licensee engaged solely in leasing spectrum to third parties. The FCC agrees with commenters that the FCC should re-evaluate its decision to limit the ability of licensees to act as service providers. The band manager rules and policies that specify that a Guard Band licensee may only act as a spectrum manager unduly restrict the ability of parties to use the spectrum, and may preclude the deployment of services that might otherwise be offered. Depending upon the circumstances, it may be that the Guard Band licensee itself is best positioned to make maximum use of the Guard Bands spectrum. Precluding a licensee from operating as a service provider may prevent access by parties that could make actual use of the band, and hinders, rather than facilitates, the efficient use of the spectrum. The FCC believes that, as long as a 700 MHz Guard Band licensee can fulfill its primary function of effectively managing its licensed spectrum and ensuring that 700 MHz public safety operations are protected from interference, there is little reason to preclude that licensee from also providing service. Accordingly, the FCC will revise its rules to permit licensees to operate as wireless service providers. To the extent that a licensee chooses to provide service, the FCC requires that the licensee update their license information if they plan to switch their regulatory status, and the FCC notes that licensees will be responsible for meeting all other obligations relating to their change in status. 50. *Restrictions on Leasing to Affiliates.* Similarly, the FCC concludes that it is in the public interest to remove the current restriction precluding any licensee from leasing more than 49.9 percent of its licensed spectrum to affiliates. As in the case of the policy precluding licensees from providing service, the FCC believes that its rule requiring that licensees lease the predominant amount of their spectrum to non-affiliates prevents entities from maximizing use of the spectrum, and hinders the provision of service to end users. This restriction also may prevent licensees and lessees from taking advantage of new technologies. To the extent that the FCC determines that broadband deployment is permissible in one or both of the 700 MHz Guard Bands, the FCC's restrictions that prevent Guard Band Managers from providing service or from leasing any more than 49.9 percent of its license to affiliates would hinder the ability of Guard Band licensees or their affiliates to deploy such service. Restrictions regarding use by the licensee or its affiliates may prevent entities from optimizing the use of the spectrum or entering into Secondary Markets spectrum leasing agreements with adjacent licensees that are not similarly restricted. Accordingly, the FCC eliminates this restriction. 51. *Other Lease Restrictions.* Under existing policies, 700 MHz Guard Band licensees are prohibited from imposing unduly restrictive requirements in the spectrum user agreements regarding access to, and use of, spectrum. In adopting these band manager rules, the FCC noted that Guard Band Managers would be afforded a considerable amount of latitude in determining the most efficient way to manage their spectrum. The FCC concluded, however, that it was necessary to ensure that band managers did not impose unreasonable terms and conditions on lessees or end users. Although these restrictions were aimed at ensuring that band managers do not engage in unreasonable practices, the existing rules may adversely affect the ability of Guard Band licensees to negotiate with spectrum users regarding otherwise standard lease provisions, such as mandating the use of a particular technology, that other wireless licensees are permitted to negotiate. The FCC notes that our Secondary Markets spectrum leasing rules do not have similar restrictions and its rules generally permit parties to determine the precise terms and provisions of their spectrum lease agreements. As noted above, the FCC is adopting for the Guard Bands the same spectrum leasing policies set forth in the Secondary Markets proceeding. The FCC believes that these policies provide sufficient incentives for licensees to lease spectrum usage rights, while also providing licensees with the ability to establish appropriate operational guidelines with spectrum lessees that protect public safety licensees from interference. As such, the FCC eliminates this requirement. 52. *Coordination Requirement.* The FCC requires Guard Band Managers to notify public safety frequency coordinators in the 700 MHz Public Safety Band, as well as adjacent-area Guard Band Managers, of the technical parameters of any site constructed in the Guard Band Manager's license area. Guard Band Managers must provide such identifying information as the frequencies coordinated, antenna height and location, and effective radiated power. The FCC does not change the coordination requirements for Guard Band licensees currently contained in § 27.601(d)(1) of its rules. The FCC notes that it imposed coordination requirements to minimize the potential for interference, and the FCC reiterates that the primary purpose of the Guard Bands is to prevent interference to adjacent public safety operations. Absent information indicating that its coordination requirements do not serve to prevent interference, the FCC concludes that we should retain the coordination requirements set forth in the rule. Given that the FCC is adopting the Secondary Markets spectrum leasing rules for the Guard Band service, the FCC clarifies how these coordination requirements will work in the context of spectrum leasing arrangements. To the extent a licensee enters into a spectrum manager lease arrangement, it retains *de facto* control of the spectrum and primary responsibility for ensuring compliance with the rules. Accordingly, for this type of spectrum leasing arrangement, the licensee is required to carry out these coordination responsibilities. If, however, a licensee enters into a *de facto* transfer leasing arrangement, the coordination and notification tasks set forth in § 27.601 of the FCC's rules (as well as other responsibilities associated with *de facto* control) are, upon FCC approval, transferred from the licensee to the spectrum lessee. In this latter type of arrangement, the FCC notes that although the spectrum lessee becomes primarily responsible for complying with the required frequency coordination responsibilities under the license authorization, the FCC will continue to hold licensees responsible for the failure of a spectrum lessee to comply with the FCC's frequency coordination requirements. Final Regulatory Flexibility Act Analysis 53. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 6 separate Initial Regulatory Flexibility Analyses
(IRFA)were incorporated in the *700 MHz Commercial Services Notice* in WT Docket No. 06-150, CC Docket No. 94-102, and WT Docket No. 01-309; the *700 MHz Guard Band Notice* , WT Docket Nos. 06-169 and 96-86; and the *700 MHz Public Safety Notice* , PS Docket No. 06-229 and WT Docket No. 96-86. 7 The Commission sought written public comment on the proposals in these dockets, including comment on the IRFA. This Final Regulatory Flexibility Analysis
(FRFA)conforms to the RFA. 8 6 *See* 5 U.S.C. 603. The RFA, *see* 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Pub. L. No. 104-121, Title II, 110 Stat. 857 (1996). 7 *See* Service Rules for the 698-749, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, and § 68.4(a) of the Commission's Rules Governing Hearing Aid-Compatible Telephones, WT Docket No. 01-309, *Notice of Proposed Rule Making, Fourth Further Notice of Proposed Rule Making, and Second Further Notice of Proposed Rule Making* , 21 FCC Rcd 9345, 9394
(2006)(“ *700 MHz Commercial Services Notice* ”); Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's Rules, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket Nos. 06-169 and 96-86, *Notice of Proposed Rule Making* , 21 FCC Rcd 10413, 10440
(2006)(“ *700 MHz Guard Bands Notice* ”); Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, PS Docket 06-229, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket No. 96-86, *Ninth Notice of Proposed Rule Making* , 21 FCC Rcd 14837, 14853
(2006)(“ *700 MHz Public Safety Ninth Notice* ”). 8 *See* 5 U.S.C. 604. 54. Although § 213 of the Consolidated Appropriations Act of 2000 provides that the RFA shall not apply to the rules and competitive bidding procedures for frequencies in the 746-806 MHz Band, 9 the Commission believes that it would serve the public interest to analyze the possible significant economic impact of the proposed policy and rule changes in this band on small entities. Accordingly, this FRFA contains an analysis of this impact in connection with all spectrum that falls within the scope of this *Report and Order,* including spectrum in the 746-806 MHz Band. 9 In particular, this exemption extends to the requirements imposed by Chapter 6 of Title 5, United States Code, § 3 of the Small Business Act (15 U.S.C. 632) and §§ 3507 and 3512 of Title 44, United States Code. Consolidated Appropriations Act 2000, Pub. L. No. 106-113, 113 Stat. 2502, Appendix E, Sec. 213(a)(4)(A)-(B); *see* 145 Cong. Rec. H12493-94 (Nov. 17, 1999); 47 U.S.C.A. 337 note at Sec. 213(a)(4)(A)-(B). A. Need for, and Objectives of, the Rules 55. In the *Report and Order* , with regard to commercial services, the Commission takes a number of steps to facilitate access to spectrum and the provision of service to consumers, especially those in rural areas, and to simplify and clarify our rules related to the commercial 700 MHz spectrum. The Commission decides that it will auction the Commercial Services licenses across a mix of geographic service area definitions. The Commission also extends the date for initial license terms from January 15, 2015, to the end of the DTV transition on February 17, 2019. With regard to radiated power limits, the Commission generally adopts a power spectral density model, with certain limitations, to provide greater operational flexibility to licensees operating at wider bandwidths, and provides for higher radiated power levels for those 700 MHz licensees operating in rural areas under the current 1 kW per MHz power limit. The Commission also modifies the 911/E911 rules to remove the service- and band-specific limitations on the applicability of those requirements. Further, the Commission finds that all digital CMRS providers, including providers in the 700 MHz, Advanced Wireless Services, and the Broadband Radio Service/Educational Broadband Service bands, along with manufacturers of handsets capable of providing such services, should be subject to the Commission's hearing aid compatibility requirements to the extent that a service satisfies the scope provision the current rules. 56. The Commission also adopts rules to enhance spectrum usage in the 700 MHz Guard Bands by replacing the Guard Band Manager spectrum leasing regime with the Secondary Markets spectrum leasing policies and rules. Guard bands licensees will have the option of entering into *de jure* and *de facto* transfer leasing arrangements. By permitting Guard Band licensees and spectrum lessees to choose between the two different options, the Commission affords licensees and spectrum lessees significant flexibility to craft the type of leasing arrangement that best matches their particular needs and the demands of the marketplace. B. Legal Basis 57. The authority for the actions taken in this *Report and Order* is contained in §§ 1, 4(i), 7, 10, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 251(e)(3), 301, 303, 307, 308, 309, 310, 311, 315, 316, 317, 324, 331, 332, 336, 337 and 710, of the Communications Act of 1934, as amended, 47 U.S.C. §§ 151, 154(i), 157, 160, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 251(e)(3), 301, 303, 307, 308, 309, 310, 311, 315, 317, 324, 331, 332, 336, 337, and 610. C. Summary of Significant Issues Raised by Public Comments in Response to the IRFA 58. No comments specifically addressed the IRFAs from any of the respective proceedings. We have nonetheless addressed small entity issues found in comments in this FRFA. D. Description and Estimate of the Number of Small Entities to Which the Rules Will Apply 59. The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. 10 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 11 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 12 A “small business concern” is one which:
(1)Is independently owned and operated;
(2)is not dominant in its field of operation; and
(3)satisfies any additional criteria established by the Small Business Administration (SBA). 13 10 5 U.S.C. 604(a)(3). 11 5 U.S.C. 601(6). 12 5 U.S.C. 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the **Federal Register** .” 13 15 U.S.C. 632. 60. *Governmental Entities.* The term “small governmental jurisdiction” is defined as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” 14 As of 2002, there were approximately 87,525 governmental jurisdictions in the United States. 15 This number includes 38,967 county governments, municipalities, and townships, of which 37,373 (approximately 95.9%) have populations of fewer than 50,000, and of which 1,594 have populations of 50,000 or more. Thus, the Commission estimates the number of small governmental jurisdictions overall to be 85,931 or fewer. 14 5 U.S.C. 601(5). 15 U.S. Census Bureau, Statistical Abstract of the United States: 2006, § 8, pages 272-273, Tables 415 and 417. 61. In the following paragraphs, the Commission further describes and estimates the number of small entity licensees that may be affected by the rules the Commission adopts in this *Report and Order.* The rule changes affect Upper 700 MHz and Lower 700 MHz Band licensees in the 698-746, 747-762, and 777-792 MHz spectrum bands, as well as all commercial mobile radio services
(CMRS)with respect to 911/E911 requirements adopted in this *Report and Order.* 62. Since this *Report and Order* applies to multiple services, this FRFA analyzes the number of small entities affected on a service-by-service basis. When identifying small entities that could be affected by the Commission's new rules, this FRFA provides information that describes auctions results, including the number of small entities that were winning bidders. However, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily reflect the total number of small entities currently in a particular service. The Commission does not generally require that licensees later provide business size information, except in the context of an assignment or a transfer of control application that involves unjust enrichment issues. Part 27 Miscellaneous Wireless Communications Services
(MWCS)63. *Wireless Communications Services.* This service can be used for fixed, mobile, radiolocation, and digital audio broadcasting satellite uses in the 2305-2320 MHz and 2345-2360 MHz bands. The Commission defined “small business” for the wireless communications services
(WCS)auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. 16 The SBA has approved these definitions. 17 The Commission auctioned geographic area licenses in the WCS service. In the auction, which commenced on April 15, 1997 and closed on April 25, 1997, there were seven bidders that won 31 licenses that qualified as very small business entities, and one bidder that won one license that qualified as a small business entity. 16 Amendment of the Commission's Rules to Establish Part 27, the Wireless Communications Service (WCS), *Report and Order* , 12 FCC Rcd 10785, 10879 ¶ 194 (1997). 17 *See* Letter to Amy Zoslov, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated December 2, 1998. 64. *700 MHz Guard Band Licenses.* In the 700 MHz Guard Band Order, the Commission adopted size standards for “small businesses” and “very small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. 18 A small business in this service is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. 19 Additionally, a “very small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. 20 SBA approval of these definitions is not required. 21 An auction of 52 Major Economic Area
(MEA)licenses commenced on September 6, 2000, and closed on September 21, 2000. 22 Of the 104 licenses auctioned, 96 licenses were sold to nine bidders. Five of these bidders were small businesses that won a total of 26 licenses. A second auction of 700 MHz Guard Band licenses commenced on February 13, 2001, and closed on February 21, 2001. All eight of the licenses auctioned were sold to three bidders. One of these bidders was a small business that won a total of two licenses. 23 18 *See* Service Rules for the 746-764 MHz Bands, and Revisions to Part 27 of the Commission's Rules, *Second Report and Order,* 15 FCC Rcd 5299 (2000). 19 *Id.* at 5343108. 20 *Id.* 21 *Id.* At 5343 ¶ 108 n.246 (for the 746-764 MHz and 776-704 MHz bands, the Commission is exempt from 15 U.S.C. 632, which requires Federal agencies to obtain Small Business Administration approval before adopting small business size standards). 22 *See* “700 MHz Guard Bands Auction Closes: Winning Bidders Announced,” *Public Notice* , 15 FCC Rcd 18026 (2000). 23 *See* “700 MHz Guard Bands Auctions Closes: Winning Bidders Announced,” *Public Notice* , 16 FCC Rcd 4590 (WTB 2001). 65. *Upper 700 MHz Band Licenses.* The Commission released a Report and Order authorizing service in the Upper 700 MHz band. 24 An auction for these licenses, previously scheduled for January 13, 2003, was postponed. 25 24 Service Rules for the 746-764 and 776-794 MHz Bands, and Revisions to Part 27 of the Commission's Rules, *Second Memorandum Opinion and Order* , 16 FCC Rcd 1239 (2001). 25 *See* “Auction of Licenses for 747-762 and 777-792 MHz Bands (Auction No. 31) Is Rescheduled,” *Public Notice* , 16 FCC Rcd 13079 (WTB 2003). 66. *Lower 700 MHz Band Licenses.* The Commission adopted criteria for defining three groups of small businesses for purposes of determining their eligibility for special provisions such as bidding credits. 26 The Commission has defined a small business as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. 27 A very small business is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. 28 Additionally, the Lower 700 MHz Band has a third category of small business status that may be claimed for Metropolitan/Rural Service Area (MSA/RSA) licenses. The third category is entrepreneur, which is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. 29 The SBA has approved these small size standards. 30 An auction of 740 licenses (one license in each of the 734 MSAs/RSAs and one license in each of the six Economic Area Groupings (EAGs)) commenced on August 27, 2002, and closed on September 18, 2002. Of the 740 licenses available for auction, 484 licenses were sold to 102 winning bidders. Seventy-two of the winning bidders claimed small business, very small business or entrepreneur status and won a total of 329 licenses. 31 A second auction commenced on May 28, 2003, and closed on June 13, 2003, and included 256 licenses: 5 EAG licenses and 476 CMA licenses. 32 Seventeen winning bidders claimed small or very small business status and won sixty licenses, and nine winning bidders claimed entrepreneur status and won 154 licenses. 33 26 *See* Reallocation and Service Rules for the 698-746 MHz Spectrum Band (Television Channels 52-59), *Report and Order* , 17 FCC Rcd 1022 (2002). 27 *Id.* at 1087-88 ¶ 172. 28 *Id.* 29 *Id.* at 1088 ¶ 173. 30 *See* Letter to Thomas Sugrue, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated August 10, 1999. 31 *See* “Lower 700 MHz Band Auction Closes,” *Public Notice* , 17 FCC Rcd 17272 (WTB 2002). 32 *See* “Lower 700 MHz Band Auction Closes,” *Public Notice* , 18 FCC Rcd 11873 (WTB 2003). 33 *Id.* 67. *Government Transfer Bands.* The Commission adopted small business size standards for the unpaired 1390-1392 MHz, 1670-1675 MHz, and the paired 1392-1395 MHz and 1432-1435 MHz bands. 34 Specifically, with respect to these bands, the Commission defined an entity with average annual gross revenues for the three preceding years not exceeding $40 million as a “small business,” and an entity with average annual gross revenues for the three preceding years not exceeding $15 million as a “very small business.” 35 Correspondingly, the Commission adopted a bidding credit of 15 percent for “small businesses” and a bidding credit of 25 percent for “very small businesses.” 36 An auction for one license in the 1670-1674 MHz band commenced on April 30, 2003 and closed the same day. One license was awarded. The winning bidder was not a small entity. 34 *See* Amendments to Parts 1, 2, 27 and 90 of the Commission's Rules to License Services in the 216-220 MHz, 1390-1395 MHz, 1427-1429 MHz, 1429-1432 MHz, 1432-1435 MHz, 1670-1675 MHz, and 2385-2390 MHz Government Transfer Bands, 17 FCC Rcd 9980
(2002)( *Government Transfer Bands Service Rules Report and Order* ). 35 *See Service Rules Notice,* 17 FCC Rcd at 2550-51 ¶¶ 144-146. To be consistent with the size standard of “very small business” proposed for the 1427-1432 MHz band for those entities with average gross revenues for the three preceding years not exceeding $3 million, the *Service Rules Notice* proposed to use the terms “entrepreneur” and “small business” to define entities with average gross revenues for the three preceding years not exceeding $40 million and $15 million, respectively. Because the Commission has not adopted a $3 million size standard for the 1427-1432 MHz band, it instead uses the terms “small business” and “very small business” to define entities with average gross revenues for the three preceding years not exceeding $40 million and $15 million, respectively. 36 *See* Reallocation of the 216-220 MHz, 1390-1395 MHz, 1427-1429 MHz, 1429-1432 MHz, 1432-1435 MHz, 1670-1675 MHz, and 2385-2390 MHz Government Transfer Bands, *Notice of Proposed Rulemaking,* 17 FCC Rcd 2500, 2550-51 ¶¶ 144-146 ( *Government Transfer Bands Service Rules Notice* ). To be consistent with the size standard of “very small business” proposed for the 1427-1432 MHz band for those entities with average gross revenues for the three preceding years not exceeding $3 million, the *Government Transfer Bands Service Rules Notice* proposed to use the terms “entrepreneur” and “small business” to define entities with average gross revenues for the three preceding years not exceeding $40 million and $15 million, respectively. Because the Commission is not adopting small business size standards for the 1427-1432 MHz band, it instead uses the terms “small business” and “very small business” to define entities with average gross revenues for the three preceding years not exceeding $40 million and $15 million, respectively. 68. *Advanced Wireless Services.* In the *AWS-1 Report and Order* , the Commission adopted rules that affect applicants who wish to provide service in the 1710-1755 MHz and 2110-2155 MHz bands. 37 The *AWS-1 Report and Order* defines a “small business” as an entity with average annual gross revenues for the preceding three years not exceeding $40 million, and a “very small business” as an entity with average annual gross revenues for the preceding three years not exceeding $15 million. The *AWS-1 Report and Order* also provides small businesses with a bidding credit of 15 percent and very small businesses with a bidding credit of 25 percent. 37 Service Rules for Advanced Wireless Services in the 1.7 GHz and 2.1 GHz Bands, WT Docket No. 02-353, *Report and Order* , 18 FCC Rcd 25162
(2003)( *AWS-1 Report and Order* ). 69. *Broadband Radio Service (formerly Multipoint Distribution Service) and Educational Broadband Service (formerly Instructional Television Fixed Service).* Multichannel Multipoint Distribution Service
(MMDS)systems, often referred to as “wireless cable,” transmit video programming to subscribers using the microwave frequencies of the Multipoint Distribution Service
(MDS)and Instructional Television Fixed Service (ITFS). 38 In its recently issued *BRS/EBS Report and Order* in WT Docket No. 03-66, the Commission comprehensively reviewed its policies and rules relating to the ITFS and MDS services, and replaced the MDS with the Broadband Radio Service and ITFS with the Educational Broadband Service in a new band plan at 2495-2690 MHz. 39 In connection with the 1996 MDS auction, the Commission defined “small business” as an entity that, together with its affiliates, has average gross annual revenues that are not more than $40 million for the preceding three calendar years. 40 The SBA has approved of this standard. 41 The MDS auction resulted in 67 successful bidders obtaining licensing opportunities for 493 Basic Trading Areas (BTAs). 42 Of the 67 auction winners, 61 claimed status as a small business. At this time, the Commission estimates that of the 61 small business MDS auction winners, 48 remain small business licensees. In addition to the 48 small businesses that hold BTA authorizations, there are approximately 392 incumbent MDS licensees that have gross revenues that are not more than $40 million and are thus considered small entities. 43 38 Amendment of Parts 21 and 74 of the Commission's Rules with Regard to Filing Procedures in the Multipoint Distribution Service and in the Instructional Television Fixed Service and Implementation of § 309(j) of the Communications Act—Competitive Bidding, MM Docket No. 94-131 and PP Docket No. 93-253, *Report and Order* , 10 FCC Rcd 9589, 9593 ¶ 7
(1995)( *MDS Auction R&O* ). 39 *See* Amendment of Parts 1, 21, 73, 74 and 101 of the Commission's Rules to Facilitate the Provision of Fixed and Mobile Broadband Access, Educational and Other Advanced Services in the 2150-2162 and 2500-2690 MHz Bands, *Report and Order and Further Notice of Proposed Rulemaking* , 19 FCC Rcd 14165
(2004)( *BRS/EBS Report and Order* and *BRS/EBS Further Notice* , respectively). 40 47 CFR 21.961(b)(1). 41 *See* Letter to Margaret Wiener, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, Federal Communications Bureau, from Gary Jackson, Assistant Administrator for Size Standards, Small Business Administration, dated Mar. 20, 2003 (noting approval of $40 million size standard for MDS auction). 42 Basic Trading Areas
(BTAs)were designed by Rand McNally and are the geographic areas by which MDS was auctioned and authorized. *See MDS Auction R&O* , 10 FCC Rcd at 9608 ¶ 34. 43 47 U.S.C. 309(j). Hundreds of stations were licensed to incumbent MDS licensees prior to implementation of § 309(j) of the Communications Act of 1934, 47 U.S.C. 309(j). For these pre-auction licenses, the applicable standard is SBA's small business size standard for “other telecommunications” (annual receipts of $12.5 million or less). *See* 13 CFR 121.201, NAICS code 517910. Additional Wireless Radio Services
(WRS)70. *Cellular Licensees.* The SBA has developed a small business size standard for small businesses in the category “Cellular and Other Wireless Telecommunications.” 44 Under that SBA category, a business is small if it has 1,500 or fewer employees. 45 For the census category of “Cellular and Other Wireless Telecommunications,” Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. 46 Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. 47 Thus, under this category and size standard, the majority of firms can be considered small. 44 13 CFR 121.201, North American Industry Classification System (NAICS) code 517212. 45 *Id.* 46 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Establishment and Firm Size (Including Legal Form of Organization),” Table 5, NAICS code 517212 (issued Nov. 2005). 47 *Id.* The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with “1000 employees or more.” 71. *220 MHz Radio Service—Phase I Licensees.* The 220 MHz service has both Phase I and Phase II licenses. Phase I licensing was conducted by lotteries in 1992 and 1993. There are approximately 1,515 such non-nationwide licensees and four nationwide licensees currently authorized to operate in the 220 MHz Band. The Commission has not developed a definition of small entities specifically applicable to such incumbent 220 MHz Phase I licensees. To estimate the number of such licensees that are small businesses, the Commission applies the small business size standard under the SBA rules applicable to “Cellular and Other Wireless Telecommunications” companies. This category provides that a small business is a wireless company employing no more than 1,500 persons. 48 For the census category of “Cellular and Other Wireless Telecommunications,” Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. 49 Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. 50 Thus, under this category and size standard, the majority of firms can be considered small. 48 13 CFR 121.201, NAICS code 517212. 49 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Establishment and Firm Size (Including Legal Form of Organization),” Table 5, NAICS code 517212 (issued Nov. 2005). 50 *Id.* The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with “1000 employees or more.” 72. *220 MHz Radio Service—Phase II Licensees* . The 220 MHz service has both Phase I and Phase II licenses. The Phase II 220 MHz service is subject to spectrum auctions. In the *220 MHz Third Report and Order* , the Commission adopted a small business size standard for defining “small” and “very small” businesses for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. 51 This small business standard indicates that a “small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. 52 A “very small business” is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that do not exceed $3 million for the preceding three years. 53 The SBA has approved these small size standards. 54 Auctions of Phase II licenses commenced on September 15, 1998, and closed on October 22, 1998. 55 In the first auction, 908 licenses were auctioned in three different-sized geographic areas: three nationwide licenses, 30 Regional Economic Area Group
(EAG)Licenses, and 875 Economic Area
(EA)Licenses. Of the 908 licenses auctioned, 693 were sold. 56 Thirty-nine small businesses won 373 licenses in the first 220 MHz auction. A second auction included 225 licenses: 216 EA licenses and 9 EAG licenses. Fourteen companies claiming small business status won 158 licenses. 57 A third auction included four licenses: 2 BEA licenses and 2 EAG licenses in the 220 MHz Service. No small or very small business won any of these licenses. 58 51 Amendment of Part 90 of the Commission's Rules to Provide For the Use of the 220-222 MHz Band by the Private Land Mobile Radio Service, *Third Report and Order* , 12 FCC Rcd 10943, 11068-70 ¶¶ 291-295 (1997). 52 *Id* . at 11068 ¶ 291. 53 *Id* . 54 *See* Letter to Daniel Phythyon, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated January 6, 1998. 55 *See generally* “220 MHz Service Auction Closes,” *Public Notice* , 14 FCC Rcd 605 (WTB 1998). 56 *See* “FCC Announces It is Prepared to Grant 654 Phase II 220 MHz Licenses After Final Payment is Made,” *Public Notice* , 14 FCC Rcd 1085 (WTB 1999). 57 *See* “Phase II 220 MHz Service Spectrum Auction Closes,” *Public Notice* , 14 FCC Rcd 11218 (WTB 1999). 58 *See* “Multi-Radio Service Auction Closes,” *Public Notice* , 17 FCC Rcd 1446 (WTB 2002). 73. *Paging* . In the *Paging Second Report and Order* , the Commission adopted a size standard for “small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. 59 A small business is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. 60 The SBA has approved this definition. 61 An auction of Metropolitan Economic Area
(MEA)licenses commenced on February 24, 2000, and closed on March 2, 2000. Of the 2,499 licenses auctioned, 985 were sold. 62 Fifty-seven companies claiming small business status won 440 licenses. 63 An auction of MEA and Economic Area
(EA)licenses commenced on October 30, 2001, and closed on December 5, 2001. Of the 15,514 licenses auctioned, 5,323 were sold. 64 132 companies claiming small business status purchased 3,724 licenses. A third auction, consisting of 8,874 licenses in each of 175 EAs and 1,328 licenses in all but three of the 51 MEAs commenced on May 13, 2003, and closed on May 28, 2003. Seventy-seven bidders claiming small or very small business status won 2,093 licenses. 65 Currently, there are approximately 24,000 Private Paging site-specific licenses and 74,000 Common Carrier Paging licenses. According to the Commission's *Trends in Telephone Service* , 375 such carriers reported that they were engaged in the provision of either paging or “messaging service.” 66 Of these, the Commission estimates that 370 are small, under the SBA-approved small business size standard. 67 The Commission estimates that the majority of private and common carrier paging providers would qualify as small entities under the SBA definition. 59 Revision of Part 22 and Part 90 of the Commission's Rules to Facilitate Future Development of Paging Systems, *Second Report and Order* , 12 FCC Rcd 2732, 2811-2812 ¶¶ 178-181 ( *Paging Second Report and Order* ); *see also* Revision of Part 22 and Part 90 of the Commission's Rules to Facilitate Future Development of Paging Systems, *Memorandum Opinion and Order on Reconsideration* , 14 FCC Rcd 10030, 10085-10088 ¶¶ 98-107 (1999). 60 *Paging Second Report and Order* , 12 FCC Rcd at 2811 ¶ 179. 61 *See* Letter to Amy Zoslov, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, from Aida Alvarez, Administrator, Small Business Administration, dated December 2, 1998. 62 *See* “929 and 931 MHz Paging Auction Closes,” *Public Notice* , 15 FCC Rcd 4858 (WTB 2000). 63 *See id* . 64 *See* “Lower and Upper Paging Band Auction Closes,” *Public Notice* , 16 FCC Rcd 21821 (WTB 2002). 65 *See* “Lower and Upper Paging Bands Auction Closes,” *Public Notice* , 18 FCC Rcd 11154 (WTB 2003). 66 *See Trends in Telephone Service* , Industry Analysis Division, Wireline Competition Bureau, Table 5.3 (Number of Telecommunications Service Providers by Size of Business) (June 2005). 67 13 CFR 121.201, NAICS code 517211. 74. *Broadband Personal Communications Service* . The broadband Personal Communications Service
(PCS)spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission has created a small business size standard for Blocks C and F as an entity that has average gross revenues of less than $40 million in the three previous calendar years. 68 For Block F, an additional small business size standard for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. 69 These small business size standards, in the context of broadband PCS auctions, have been approved by the SBA. 70 No small businesses within the SBA-approved small business size standards bid successfully for licenses in Blocks A and B. There were 90 winning bidders that qualified as small entities in the C Block auctions. A total of 93 “small” and “very small” business bidders won approximately 40 percent of the 1,479 licenses for Blocks D, E, and F. 71 On March 23, 1999, the Commission reauctioned 155 C, D, E, and F Block licenses; there were 113 small business winning bidders. 72 On January 26, 2001, the Commission completed the auction of 422 C and F PCS licenses in Auction 35. 73 Of the 35 winning bidders in this auction, 29 qualified as “small” or “very small” businesses. Subsequent events concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. 68 *See* Amendment of Parts 20 and 24 of the Commission's Rules—Broadband PCS Competitive Bidding and the Commercial Mobile Radio Service Spectrum Cap, *Report and Order* , 11 FCC Rcd 7824, 7850-7852 ¶¶ 57-60 (1996); *see also* 47 CFR 24.720(b). 69 *See* Amendment of Parts 20 and 24 of the Commission's Rules—Broadband PCS Competitive Bidding and the Commercial Mobile Radio Service Spectrum Cap, *Report and Order* , 11 FCC Rcd 7824, 7852 ¶ 60. 70 *See* Letter to Amy Zoslov, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated December 2, 1998. 71 FCC News, “Broadband PCS, D, E and F Block Auction Closes,” No. 71744 (rel. January 14, 1997). 72 *See* “C, D, E, and F Block Broadband PCS Auction Closes,” *Public Notice* , 14 FCC Rcd 6688 (WTB 1999). 73 *See* “C and F Block Broadband PCS Auction Closes; Winning Bidders Announced,” *Public Notice* , 16 FCC Rcd 2339 (2001). 75. *Narrowband Personal Communications Service* . The Commission held an auction for Narrowband Personal Communications Service
(PCS)licenses that commenced on July 25, 1994, and closed on July 29, 1994. A second commenced on October 26, 1994 and closed on November 8, 1994. For purposes of the first two Narrowband PCS auctions, “small businesses” were entities with average gross revenues for the prior three calendar years of $40 million or less. 74 Through these auctions, the Commission awarded a total of forty-one licenses, 11 of which were obtained by four small businesses. 75 To ensure meaningful participation by small business entities in future auctions, the Commission adopted a two-tiered small business size standard in the *Narrowband PCS Second Report and Order* . 76 A “small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $40 million. 77 A “very small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $15 million. 78 The SBA has approved these small business size standards. 79 A third auction commenced on October 3, 2001 and closed on October 16, 2001. Here, five bidders won 317 (MTA and nationwide) licenses. 80 Three of these claimed status as a small or very small entity and won 311 licenses. 74 Implementation of Section 309(j) of the Communications Act—Competitive Bidding Narrowband PCS, *Third Memorandum Opinion and Order and Further Notice of Proposed Rulemaking* , 10 FCC Rcd 175, 196 ¶ 46 (1994). 75 *See* “Announcing the High Bidders in the Auction of ten Nationwide Narrowband PCS Licenses, Winning Bids Total $617,006,674,” *Public Notice* , PNWL 94-004 (rel. Aug. 2, 1994); “Announcing the High Bidders in the Auction of 30 Regional Narrowband PCS Licenses; Winning Bids Total $490,901,787,” *Public Notice* , PNWL 94-27 (rel. Nov. 9, 1994). 76 Amendment of the Commission's Rules to Establish New Personal Communications Services, Narrowband PCS, *Second Report and Order and Second Further Notice of Proposed Rule Making* , 15 FCC Rcd 10456, 10476 ¶ 40 (2000). 77 *Id* . 78 *Id* . 79 *See* Letter to Amy Zoslov, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated December 2, 1998. 80 *See* “Narrowband PCS Auction Closes,” *Public Notice* , 16 FCC Rcd 18663 (WTB 2001). 76. *Specialized Mobile Radio* . The Commission awards “small entity” bidding credits in auctions for Specialized Mobile Radio
(SMR)geographic area licenses in the 800 MHz and 900 MHz bands to firms that had revenues of no more than $15 million in each of the three previous calendar years. 81 The Commission awards “very small entity” bidding credits to firms that had revenues of no more than $3 million in each of the three previous calendar years. 82 The SBA has approved these small business size standards for the 900 MHz Service. 83 The Commission has held auctions for geographic area licenses in the 800 MHz and 900 MHz bands. The 900 MHz SMR auction began on December 5, 1995, and closed on April 15, 1996. Sixty bidders claiming that they qualified as small businesses under the $15 million size standard won 263 geographic area licenses in the 900 MHz SMR band. The 800 MHz SMR auction for the upper 200 channels began on October 28, 1997, and was completed on December 8, 1997. Ten bidders claiming that they qualified as small businesses under the $15 million size standard won 38 geographic area licenses for the upper 200 channels in the 800 MHz SMR band. 84 A second auction for the 800 MHz band was held on January 10, 2002 and closed on January 17, 2002 and included 23 BEA licenses. One bidder claiming small business status won five licenses. 85 81 47 CFR 90.814(b)(1). 82 *Id* . 83 *See* Letter to Thomas Sugrue, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated August 10, 1999. The Commission notes that, although a request was also sent to the SBA requesting approval for the small business size standard for 800 MHz, approval is still pending. 84 *See* “Correction to Public Notice DA 96-586 ‘FCC Announces Winning Bidders in the Auction of 1020 Licenses to Provide 900 MHz SMR in Major Trading Areas,’ ” *Public Notice* , 18 FCC Rcd 18367 (WTB 1996). 85 *See* “Multi-Radio Service Auction Closes,” *Public Notice* , 17 FCC Rcd 1446 (WTB 2002). 77. The auction of the 1,050 800 MHz SMR geographic area licenses for the General Category channels began on August 16, 2000, and was completed on September 1, 2000. Eleven bidders won 108 geographic area licenses for the General Category channels in the 800 MHz SMR band qualified as small businesses under the $15 million size standard. In an auction completed on December 5, 2000, a total of 2,800 Economic Area licenses in the lower 80 channels of the 800 MHz SMR service were sold. Of the 22 winning bidders, 19 claimed “small business” status and won 129 licenses. Thus, combining all three auctions, 40 winning bidders for geographic licenses in the 800 MHz SMR band claimed status as small business. 78. In addition, there are numerous incumbent site-by-site SMR licensees and licensees with extended implementation authorizations in the 800 and 900 MHz bands. The Commission does not know how many firms provide 800 MHz or 900 MHz geographic area SMR pursuant to extended implementation authorizations, nor how many of these providers have annual revenues of no more than $3 million or $15 million (the special small business size standards), or have no more than 1,500 employees (the generic SBA standard for wireless entities, discussed, *supra* ). One firm has over $15 million in revenues. The Commission assumes, for purposes of this analysis, that all of the remaining existing extended implementation authorizations are held by small entities. 79. *Private Land Mobile Radio* . Private Land Mobile Radio
(PLMR)systems serve an essential role in a range of industrial, business, land transportation, and public safety activities. These radios are used by companies of all sizes operating in all U.S. business categories, and are often used in support of the licensee's primary (non-telecommunications) business operations. The SBA has developed a small business size standard for the economic census category, “Cellular and Other Wireless Telecommunications,” which is any such entity employing no more than 1,500 persons. 86 The Commission does not require PLMR licensees to disclose information about number of employees, so the Commission does not have information that could be used to determine how many PLMR licensees constitute small entities under this definition. 86 *See* 13 CFR 121.201, NAICS code 517212. 80. *Fixed Microwave Services* . Fixed microwave services include common carrier, 87 private-operational fixed, 88 and broadcast auxiliary radio services. 89 Currently, there are approximately 22,015 common carrier fixed licensees and 61,670 private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services. The Commission has not yet defined a small business with respect to microwave services. As noted, the SBA has developed a small business size for the broad census category, “Cellular and Other Wireless Telecommunications” companies—that is, an entity with no more than 1,500 persons. 90 The Commission does not have data specifying the number of these licensees that have more than 1,500 employees, and thus is unable at this time to estimate with greater precision the number of fixed microwave service licensees that would qualify as small business concerns under the SBA's small business size standard. Consequently, the Commission estimates that there are 22,015 or fewer small common carrier fixed licensees and 61,670 or fewer small private operational-fixed licensees and small broadcast auxiliary radio licensees in the microwave services that may be affected by the rules and policies adopted herein. The Commission notes, however, that the common carrier microwave fixed licensee category includes some large entities. 87 47 CFR 101 *et seq.* (formerly, part 21 of the Commission's Rules). 88 Persons eligible under parts 80 and 90 of the Commission's rules can use Private Operational-Fixed Microwave services. *See generally* 47 CFR parts 80 and 90. Stations in this service are called operational-fixed to distinguish them from common carrier and public fixed stations. Only the licensee may use the operational-fixed station, and only for communications related to the licensee's commercial, industrial, or safety operations. 89 Auxiliary Microwave Service is governed by part 74 of Title 47 of the Commission's Rules. *See* 47 CFR part 74. Available to licensees of broadcast stations and to broadcast and cable network entities, broadcast auxiliary microwave stations are used for relaying broadcast television signals from the studio to the transmitter, or between two points such as a main studio and an auxiliary studio. The service also includes mobile TV pickups, which relay signals from a remote location back to the studio. 90 13 CFR 121.201, NAICS code 517212. 81. *39 GHz Service* . The Commission defines “small entity” for 39 GHz licenses as an entity that has average gross revenues of less than $40 million in the three previous calendar years. 91 “Very small business” is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. 92 The SBA has approved these definitions. 93 The auction of the 2,173 39 GHz licenses began on April 12, 2000, and closed on May 8, 2000. The 18 bidders who claimed small business status won 849 licenses. 91 *See* Amendment of the Commission's Rules Regarding the 37.0-38.6 GHz and 38.6-40.0 GHz Band, *Report and Order* , 12 FCC Rcd 18600 (1997). 92 *Id* . 93 *See* Letter to Margaret Wiener, Chief, Auctions and Industry Analysis Division, Wireless Telecommunications Bureau, Federal Communications Commission, from Hector Barreto, Administrator, Small Business Administration, dated January 18, 2002. 82. *Local Multipoint Distribution Service.* An auction of the 986 Local Multipoint Distribution Service
(LMDS)licenses began on February 18, 1998, and closed on March 25, 1998. The Commission defined “small entity” for LMDS licenses as an entity that has average gross revenues of less than $40 million in the three previous calendar years. 94 An additional classification for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. 95 These regulations defining “small entity” in the context of LMDS auctions have been approved by the SBA. 96 There were 93 winning bidders that qualified as small entities in the LMDS auctions. A total of 93 small and very small business bidders won approximately 277 A Block licenses and 387 B Block licenses. On March 27, 1999, the Commission re-auctioned 161 licenses; there were 32 small and very small business winning bidders that won 119 licenses. 94 *See* Rulemaking to Amend Parts 1, 2, 21, 25, of the Commission's Rules to Redesignate the 27.5-29.5 GHz Frequency Band, Reallocate the 29.5-30.5 Frequency Band, to Establish Rules and Policies for Local Multipoint Distribution Service and for Fixed Satellite Services, *Second Report and Order, Order on Reconsideration, and Fifth Notice of Proposed Rule Making* , 12 FCC Rcd 12545, 12689-90 ¶ 348 (1997). 95 *Id.* 96 *See* Letter to Daniel Phythyon, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated January 6, 1998. 83. *218-219 MHz Service.* The first auction of 218-219 MHz (previously referred to as the Interactive and Video Data Service or IVDS) spectrum resulted in 178 entities winning licenses for 594 Metropolitan Statistical Areas (MSAs). 97 Of the 594 licenses, 567 were won by 167 entities qualifying as a small business. For that auction, the Commission defined a small business as an entity that, together with its affiliates, has no more than a $6 million net worth and, after federal income taxes (excluding any carry over losses), has no more than $2 million in annual profits each year for the previous two years. 98 For future auctions in the *218-219 MHz Report and Order and Memorandum Opinion and Order,* the Commission defined a small business as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and their affiliates, has average annual gross revenues not exceeding $15 million for the preceding three years. 99 A very small business is defined as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and its affiliates, has average annual gross revenues not exceeding $3 million for the preceding three years. 100 The SBA has approved of these definitions. 101 At this time, no additional auction is scheduled. 97 *See* “Interactive Video and Data Service
(IVDS)Applications Accepted for Filing,” *Public Notice* , 9 FCC Rcd 6227 (1994). 98 Implementation of Section 309(j) of the Communications Act—Competitive Bidding, *Fourth Report and Order* , 9 FCC Rcd 2330 (1994). 99 Amendment of Part 95 of the Commission's Rules to Provide Regulatory Flexibility in the 218-219 MHz Service, *Report and Order and Memorandum Opinion and Order* , 15 FCC Rcd 1497 (1999). 100 *Id.* 101 *See* Letter to Daniel Phythyon, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated January 6, 1998. 84. *Location and Monitoring Service.* Multilateration Location and Monitoring Service
(LMS)systems use non-voice radio techniques to determine the location and status of mobile radio units. For purposes of auctioning LMS licenses, the Commission has defined “small business” as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the preceding three years not exceeding $15 million. 102 A “very small business” is defined as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the preceding three years not exceeding $3 million. 103 These definitions have been approved by the SBA. 104 An auction for multilateration LMS licenses commenced on February 23, 1999, and closed on March 5, 1999. Of the 528 licenses auctioned, 289 licenses were sold to four small businesses. In addition, there are numerous site-by-site non-multilateration licensees, and the Commission does not know how many of these providers have annual revenues of no more than $3 million or $15 million (the special small business size standards), or have no more than 1,500 employees (the generic SBA standard for wireless entities, discussed *supra* ). The Commission assumes, for purposes of this analysis, that all of these licenses are held by small entities. 102 Amendment of Part 90 of the Commission's Rules to Adopt Regulations for Automatic Vehicle Monitoring Systems, *Second Report and Order,* 13 FCC Rcd 15182, 15192 ¶ 20 (1998); *see also* 47 CFR 90.1103. 103 Amendment of Part 90 of the Commission's Rules to Adopt Regulations for Automatic Vehicle Monitoring Systems, *Second Report and Order* , 13 FCC Rcd at 15192 ¶ 20; *see also* 47 CFR 90.1103. 104 *See* Letter to Thomas Sugrue, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated Feb. 22, 1999. 85. *Rural Radiotelephone Service.* The Commission uses the SBA small business size standard applicable to cellular and other wireless telecommunication companies, *i.e.* , an entity employing no more than 1,500 persons. 105 There are approximately 1,000 licensees in the Rural Radiotelephone Service, and the Commission estimates that there are 1,000 or fewer small entity licensees in the Rural Radiotelephone Service that may be affected by the rules and policies adopted herein. 105 13 CFR 121.201, NAICS code 517212. 86. *Air-Ground Radiotelephone Service.* The Commission uses the SBA small business size standard applicable to cellular and other wireless telecommunication companies, *i.e.* , an entity employing no more than 1,500 persons. 106 There are approximately 100 licensees in the Air-Ground Radiotelephone Service, and the Commission estimates that almost all of them qualify as small entities under the SBA standard. 106 *Id.* 87. *Offshore Radiotelephone Service.* This service operates on several ultra high frequency
(UHF)TV broadcast channels that are not used for TV broadcasting in the coastal area of the states bordering the Gulf of Mexico. At present, there are approximately 55 licensees in this service. The Commission uses the SBA small business size standard applicable to cellular and other wireless telecommunication companies, *i.e.* , an entity employing no more than 1,500 persons. 107 The Commission is unable at this time to estimate the number of licensees that would qualify as small entities under the SBA standard. The Commission assumes, for purposes of this analysis, that all of the 55 licensees are small entities, as that term is defined under the SBA standard. 107 *Id.* 88. *Multiple Address Systems.* Entities using Multiple Address Systems
(MAS)spectrum, in general, fall into two categories:
(1)Those using the spectrum for profit-based uses, and
(2)those using the spectrum for private internal uses. With respect to the first category, the Commission defines “small entity” for MAS licenses as an entity that has average gross revenues of less than $15 million in the three previous calendar years. 108 “Very small business” is defined as an entity that, together with its affiliates, has average gross revenues of not more than $3 million for the preceding three calendar years. 109 The SBA has approved of these special small business size standards. 110 The majority of these entities will most likely be licensed in bands where the Commission has implemented a geographic area licensing approach that would require the use of competitive bidding procedures to resolve mutually exclusive applications. The Commission's licensing database indicates that, as of January 20, 1999, there were a total of 8,670 MAS station authorizations. Of these, 260 authorizations were associated with common carrier service. In addition, an auction for 5,104 MAS licenses in 176 EAs began November 14, 2001, and closed on November 27, 2001. 111 Seven winning bidders claimed status as small or very small businesses and won 611 licenses. 108 *See* Amendment of the Commission's Rules Regarding Multiple Address Systems, *Report and Order* , 15 FCC Rcd 11956, 12008 ¶ 123 (2000). 109 *Id.* 110 *See* Letter to Thomas Sugrue, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, Small Business Administration, dated June 4, 1999. 111 *See* “Multiple Address Systems Spectrum Auction Closes,” *Public Notice* , 16 FCC Rcd 21011 (2001). 89. With respect to the second category, which consists of entities that use, or seek to use, MAS spectrum to accommodate their own internal communications needs, MAS serves an essential role in a range of industrial, safety, business, and land transportation activities. MAS radios are used by companies of all sizes, operating in virtually all U.S. business categories, and by all types of public safety entities. As noted, the SBA has developed a small business size standard for the broad economic census category, “Cellular and Other Wireless Telecommunications,” which is any such entity employing no more than 1,500 persons. 112 The Commission's licensing database indicates that, as of January 20, 1999, of the 8,670 total MAS station authorizations, 8,410 authorizations were for private radio service, and of these, 1,433 were for private land mobile radio service. 112 *See* 13 CFR 121.201, NAICS code 517212. 90. *Incumbent 24 GHz Licensees.* The rules at issue could affect incumbent licensees who were relocated to the 24 GHz band from the 18 GHz band, and applicants who wish to provide services in the 24 GHz band. As noted, the SBA has developed a small business size standard for the broad economic census category, “Cellular and Other Wireless Telecommunications,” which is any such entity employing no more than 1,500 persons. 113 The Commission believes that there are only two licensees in the 24 GHz band that were relocated from the 18 GHz band, Teligent 114 and TRW, Inc. The Commission understands that Teligent and its related companies have less than 1,500 employees, though this may change in the future. TRW is not a small entity. Thus, only one incumbent licensee in the 24 GHz band is a small business entity. 113 * See Id.* 114 Teligent acquired the Digital Electronic Message Service
(DEMS)licenses of FirstMark, the only licensee other than TRW in the 24 GHz band whose license has been modified to require relocation to the 24 GHz band. 91. *Future 24 GHz Licensees.* With respect to new applicants in the 24 GHz band, the Commission has defined “small business” as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the three preceding years not exceeding $15 million. 115 “Very small business” in the 24 GHz band is defined as an entity that, together with controlling interests and affiliates, has average gross revenues not exceeding $3 million for the preceding three years. 116 The SBA has approved these size standards. At this time, no additional auction is scheduled. 115 Amendments to Parts 1, 2, 87 and 101 of the Commission's Rules To License Fixed Services at 24 GHz, *Report and Order* , 15 FCC Rcd 16934, 16967 ¶ 77
(2000)( *24 GHz Report and Order* ); *see also* 47 CFR 101.538(a)(2). 116 *24 GHz Report and Order* , 15 FCC Rcd at 16967 ¶ 77; *see also* 47 CFR 101.538(a)(1). 92. *Cable and Other Program Distribution.* The SBA has developed a small business size standard for Cable and Other Program Distribution, which is: All such firms having $13.5 million or less in annual receipts. 117 According to Census Bureau data for 2002, there were a total of 1,191 firms in this category that operated for the entire year. 118 Of this total, 1,087 firms had annual receipts of under $10 million, and 43 firms had receipts of $10 million or more but less than $25 million. 119 Thus, under this size standard, the majority of firms can be considered small. 117 13 CFR 121.201, NAICS code 517510. 118 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, Table 4, Receipts Size of Firms for the United States: 2002, NAICS code 517510 (issued November 2005). 119 *Id.* An additional 61 firms had annual receipts of $25 million or more. 93. *Cable Television Relay Service.* This service includes transmitters generally used to relay cable programming within cable television system distribution systems. The Census Bureau has defined a category of Cable and Other Program Distribution as follows: “This industry comprises establishments primarily engaged as third-party distribution systems for broadcast programming. The establishments of this industry deliver visual, aural, or textual programming received from cable networks, local television stations, or radio networks to consumers via cable or direct-to-home satellite systems on a subscription or fee basis. These establishments do not generally originate programming material.” 120 The SBA has developed a small business size standard for Cable and Other Program Distribution, which is: All such firms having $13.5 million or less in annual receipts. 121 According to Census Bureau data for 2002, there were a total of 1,191 firms in this category that operated for the entire year. 122 Of this total, 1,087 firms had annual receipts of under $10 million, and 43 firms had receipts of $10 million or more but less than $25 million. 123 Thus, under this size standard, the majority of firms can be considered small. 120 U.S. Census Bureau, 2002 NAICS Definitions, “517510 Cable and Other Program Distribution”; *http://www.census.gov/epcd/naics02/def/NDEF517.HTM.* 121 13 CFR 121.201, NAICS code 517510. 122 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, Table 4, Receipts Size of Firms for the United States: 2002, NAICS code 517510 (issued November 2005). 123 *Id.* An additional 61 firms had annual receipts of $25 million or more. 94. *Cable Companies and Systems.* The Commission has also developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers, nationwide. 124 Industry data indicate that, of 1,076 cable operators nationwide, all but eleven are small under this size standard. 125 In addition, under the Commission's rules, a “small system” is a cable system serving 15,000 or fewer subscribers. 126 Industry data indicate that, of 7,208 systems nationwide, 6,139 systems have under 10,000 subscribers, and an additional 379 systems have 10,000-19,999 subscribers. 127 Thus, under this second size standard, most cable systems are small. 124 47 CFR 76.901(e). The Commission determined that this size standard equates approximately to a size standard of $100 million or less in annual revenues. *Implementation of Sections of the 1992 Cable Act: Rate Regulation* , Sixth Report and Order and Eleventh Order on Reconsideration, 10 FCC Rcd 7393, 7408 (1995). 125 These data are derived from: R.R. Bowker, *Broadcasting & Cable Yearbook 2006* , “Top 25 Cable/Satellite Operators,” pages A-8 and C-2 (data current as of June 30, 2005); Warren Communications News, *Television & Cable Factbook 2006* , “Ownership of Cable Systems in the United States,” pages D-1805 to D-1857. 126 47 CFR 76.901(c). 127 Warren Communications News, *Television & Cable Factbook 2006* , “U.S. Cable Systems by Subscriber Size,” page F-2 (data current as of Oct. 2005). The data do not include 718 systems for which classifying data were not available. 95. *Cable System Operators.* The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” 128 The Commission has determined that an operator serving fewer than 677,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. 129 Industry data indicate that, of 1,076 cable operators nationwide, all but ten are small under this size standard. 130 The Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, 131 and therefore it is unable to estimate more accurately the number of cable system operators that would qualify as small under this size standard. 128 47 U.S.C. 43(m)(2); *see* 47 CFR 76.901(f) and nn. 1-3. 129 47 CFR 76.901(f); *see* Public Notice, *FCC Announces New Subscriber Count for the Definition of Small Cable Operator* , DA 01-158 (Cable Services Bureau, Jan. 24, 2001). 130 These data are derived from: R.R. Bowker, *Broadcasting & Cable Yearbook 2006* , “Top 25 Cable/Satellite Operators,” pages A-8 and C-2 (data current as of June 30, 2005); Warren Communications News, *Television & Cable Factbook 2006* , “Ownership of Cable Systems in the United States,” pages D-1805 to D-1857. 131 The Commission does receive such information on a case-by-case basis if a cable operator appeals a local franchise authority's finding that the operator does not qualify as a small cable operator pursuant to § 76.901(f) of the Commission's rules. *See* 47 CFR 76.909(b). 96. *Multichannel Video Distribution and Data Service.* Multichannel Video Distribution and Data Service (MVDDS) is a terrestrial fixed microwave service operating in the 12.2-12.7 GHz band. Licenses in this service were auctioned in January 2004, with 10 winning bidders for 192 licenses. Eight of these 10 winning bidders claimed small businesses status for 144 of these licenses. 132 132 “Multichannel Video Distribution and Data Service Auction Closes,” *Public Notice* , DA 04-215 (Feb. 2, 2004). 97. *Amateur Radio Service.* These licensees are believed to be individuals, and therefore are not small entities. 98. *Aviation and Marine Services.* Small businesses in the aviation and marine radio services use a very high frequency
(VHF)marine or aircraft radio and, as appropriate, an emergency position-indicating radio beacon (and/or radar) or an emergency locator transmitter. The Commission has not developed a small business size standard specifically applicable to these small businesses. As noted, the SBA has developed a small business size standard for the broad economic census category, “Cellular and Other Wireless Telecommunications,” which is any such entity employing no more than 1,500 persons. 133 Most applicants for recreational licenses are individuals. Approximately 581,000 ship station licensees and 131,000 aircraft station licensees operate domestically and are not subject to the radio carriage requirements of any statute or treaty. For purposes of the Commission's evaluations in this analysis, the Commission estimates that there are up to approximately 712,000 licensees that are small businesses (or individuals) under the SBA standard. In addition, between December 3, 1998 and December 14, 1998, the Commission held an auction of 42 VHF Public Coast licenses in the 157.1875-157.4500 MHz (ship transmit) and 161.775-162.0125 MHz (coast transmit) bands. For purposes of the auction, the Commission defined a “small” business as an entity that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed $15 million dollars. In addition, a “very small” business is one that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed $3 million dollars. 134 There are approximately 10,672 licensees in the Marine Coast Service, and the Commission estimates that almost all of them qualify as “small” businesses under the above special small business size standards. 133 13 CFR 121.201, NAICS code 517212. 134 Amendment of the Commission's Rules Concerning Maritime Communications, *Third Report and Order and Memorandum Opinion and Order* , 13 FCC Rcd 19853 (1998). 99. *Personal Radio Services.* Personal radio services provide short-range, low power radio for personal communications, radio signaling, and business communications not provided for in other services. The Personal Radio Services include spectrum licensed under part 95 of the rules. 135 These services include Citizen Band Radio Service (CB), General Mobile Radio Service (GMRS), Radio Control Radio Service (R/C), Family Radio Service (FRS), Wireless Medical Telemetry Service (WMTS), Medical Implant Communications Service (MICS), Low Power Radio Service (LPRS), and Multi-Use Radio Service (MURS). 136 There are a variety of methods used to license the spectrum in these rule parts, from licensing by rule, to conditioning operation on successful completion of a required test, to site-based licensing, to geographic area licensing. Under the RFA, the Commission is required to make a determination of which small entities are directly affected by the rules being adopted. Since all such entities are wireless, the Commission applies the small business size standard “Cellular and Other Wireless Telecommunications,” pursuant to which a small entity is defined as employing 1,500 or fewer persons. 137 Many of the licensees in these services are individuals, and thus are not small entities. In addition, due to the mostly unlicensed and shared nature of the spectrum utilized in many of these services, the Commission lacks direct information upon which to base an estimation of the number of small entities under an SBA definition that might be directly affected by the proposed rules. 135 47 CFR part 90. 136 The Citizens Band Radio Service, General Mobile Radio Service, Radio Control Radio Service, Family Radio Service, Wireless Medical Telemetry Service, Medical Implant Communications Service, Low Power Radio Service, and Multi-Use Radio Service are governed by subpart D, subpart A, subpart C, subpart B, subpart H, subpart I, subpart G, and subpart J, respectively, of part 95 of the Commission's rules. *See generally* 47 CFR part 95. 137 13 CFR 121.201, NAICS Code 517212. 100. Despite the paucity, or in some instances, total absence, of information about their status as licensees or regulatees or the number of operators in each such service, users of spectrum in these services are listed here as a matter of Commission discretion in order to fulfill the mandate imposed on the Commission by the RFA to regulate small business entities with an understanding towards preventing the possible differential and adverse impact of the Commission's rules on smaller entities. Further, the listing of such entities, despite their indeterminate status, should provide them with fair and adequate notice of the possible impact of the instant proposals. 101. *Public Safety Radio Licensees.* As a general matter, public safety radio licensees include police, fire, local government, forestry conservation, highway maintenance, and emergency medical services. 138 The SBA rules contain a small business size standard for “Cellular and Other Wireless Telecommunications,” which encompass business entities engaged in wireless communications employing no more than 1,500 persons. 139 According to Census Bureau data for 2002, in this category there was a total of 8,863 firms that operated for the entire year. 140 Of this total, 401 firms had 100 or more employees, and the remainder had fewer than 100 employees. 141 With respect to local governments, in particular, since many governmental entities as well as private businesses comprise teh licenses for these services, the Commission includes under public safety services the number of government entities affected. 138 *See* subparts A and B of part 90 of the Commission's Rules, 47 CFR 90.1-90.22. Police licensees include 26,608 licensees that serve state, county, and municipal enforcement through telephony (voice), telegraphy (code), and teletype and facsimile (printed material). Fire licensees include 22,677 licensees comprised of private volunteer or professional fire companies, as well as units under governmental control. Public Safety Radio Pool licensees also include 40,512 licensees that are state, county, or municipal entities that use radio for official purposes. There are also 7,325 forestry service licensees comprised of licensees from state departments of conservation and private forest organizations that set up communications networks among fire lookout towers and ground crews. The 9,480 state and local governments are highway maintenance licensees that provide emergency and routine communications to aid other public safety services to keep main roads safe for vehicular traffic. Emergency medical licensees (1,460) use these channels for emergency medical service communications related to the delivery of emergency medical treatment. Another 19,478 licensees include medical services, rescue organizations, veterinarians, persons with disabilities, disaster relief organizations, school buses, beach patrols, establishments in isolated areas, communications standby facilities, and emergency repair of public communications facilities. 139 *See* 13 CFR 121.201 (NAICS code 517212); U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Employment Size of Establishments for the United States: 2002,” Table 2, NAICS code 517212. 140 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Employment Size of Establishments for the United States: 2002,” Table 2, NAICS code 517212. 141 *Id.* 102. *Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.* The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” 142 The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: All such firms having 750 or fewer employees. 143 According to Census Bureau data for 2002, there were a total of 1,041 establishments in this category that operated for the entire year. 144 Of this total, 1,010 had employment of under 500, and an additional 13 had employment of 500 to 999. 145 Thus, under this size standard, the majority of firms can be considered small. 142 U.S. Census Bureau, 2002 NAICS Definitions, “334220 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing”; *http://www.census.gov/epcd/naics02/def/NDEF334.HTM#N3342.* 143 13 CFR 121.201, NAICS code 334220. 144 U.S. Census Bureau, American FactFinder, 2002 Economic Census, Industry Series, Industry Statistics by Employment Size, NAICS code 334220 (released May 26, 2005); http://factfinder.census.gov. The number of “establishments” is a less helpful indicator of small business prevalence in this context than would be the number of “firms” or “companies,” because the latter take into account the concept of common ownership or control. Any single physical location for an entity is an establishment, even though that location may be owned by a different establishment. Thus, the numbers given may reflect inflated numbers of businesses in this category, including the numbers of small businesses. In this category, the Census breaks-out data for firms or companies only to give the total number of such entities for 2002, which was 929. 145 *Id.* An additional 18 establishments had employment of 1,000 or more. E. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities 103. The projected reporting, recordkeeping, and other compliance requirements resulting from the Report and Order will apply to all entities in the same manner. The Commission believes that applying the same rules equally to all entities promotes fairness. The Commission does not believe that the costs and/or administrative burdens associated with the rules will unduly burden small entities. The revisions the Commission adopts should benefit small entities by giving them more information, more flexibility, and more options for gaining access to valuable wireless spectrum. 104. *Renewal Procedures.* In this *Report and Order* , the Commission revises § 27.14 of the rules to eliminate the filing of competing applications at the time of the renewal of 700 MHz licenses. This rule change will relieve all licensees, including small businesses that hold or will hold licenses in the 700 MHz Band the burden of possibly facing a comparative hearing. The *Report and Order* also clarifies that within the renewal context, all licensees must make a substantial service showing and demonstrate that they have substantially complied with the Commission's rules, policies, and the Communications Act of 1934, as amended. 146 This requirement is distinct from the performance requirements that the Commission seeks comment on in the *Further Notice.* 146 *See* 47 CFR 27.14 (2006). 105. *911/E911.* There is no general reporting or recordkeeping requirements for 911/E911 compliance. The 911/E911 obligations established in § 20.18 of our rules, however, are extended to cover all commercial mobile radio services (CMRS), including services licensed in the 700 MHz Commercial Services Band and the AWS-1 bands, to the same extent as they apply to wireless services currently listed in the scope provision of § 20.18. The Commission will continue, however, to exclude MSS from § 20.18 in conformity with the Commission's decision in the *E911 Scope Order.* 147 All other CMRS providers must comply with the 911/E911 requirements to the extent that they offer real-time, two way switched voice service that is interconnected with the public switched network and utilize an in-network-switching facility that enables the provider to reuse frequencies and accomplish seamless hand-offs of subscriber calls. 148 The Commission finds that this extension of 911/E911 requirements, while substantial for small carriers, is justified by the interest in competitive neutrality as well as by the critical public safety benefits of 911/E911. To the extent that special circumstances arise in particular situations where compliance may not be technically or economically feasible, waiver relief is available on a case-by-case basis. In addition, to the extent that carriers pursue a handset-based compliance solution, implementation should be easier than in previous 911/E911 compliance instances involving other services. Given that the 911/E911 requirements in part 27 will be imposed prior to the commencement of services in the 700 MHz band, all of the subscribers to the new services will have compliant handsets from the commencement of service. Small carriers will therefore not have the complication of replacing phones that lack 911/E911 capability. 147 The Commission initially excluded MSS from § 20.18 in the *E911 Report and Order.* *See* Revision of the Commission's Rules To Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, *Report and Order and Further Notice of Proposed Rulemaking* , 11 FCC Rcd 18676, 18718 ¶ 83
(1996)( *E911 Report and Order* ). In the *E911 Scope Order* , upon revisiting the issue, the Commission recognized that MSS operators continued to faced unique difficulties in implementing 911 and E911 obligations, and therefore declined to apply the obligations of § 20.18 and instead imposed a separate, limited 911 requirement specifically for MSS, including a requirement to establish emergency call centers. *See* Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket 94-102, IB Docket No. 99-67, *Report and Order and Further Notice of Proposed Rulemaking* , 18 FCC Rcd 25340, 25347-57 ¶¶ 20-39
(2003)(“ *E911 Scope Order* ”). 148 47 CFR 20.18(a). 106. *Public Safety Notification.* In this *Report and Order* , the Commission takes steps to address potential intermodulation (“IM”) to public safety operations in the 700 MHz Band. Specifically, as the Commission did with respect to 800 MHz ESMR and Cellular licensees, 149 the Commission will require 700 MHz Commercial Services Band licensees, upon request from a 700 MHz public safety entity, to provide to that entity information about the location and parameters of any stations they plan to activate in the public safety entity's area of operation. 150 The Commission will also require, as it did in § 90.675, public safety licensees to provide, upon request of a 700 MHz Commercial Services Band licensee, the operating parameters of their radio systems. 151 As indicated in the *800 MHz Report and Order,* these actions can both help prevent potential interference from occurring and help identify possible sources of interference more rapidly, if interference were to occur. 152 It is not anticipated that it will be onerous for small businesses to come into compliance with this requirement, which is triggered only upon a request from a public safety entity. The information to be reported is of a type that the licensee will likely have readily available. 149 *See* 47 CFR 90.675. 150 As per § 90.675, this would include information about the 700 MHz station's location, effective radiated power, antenna height, and channels available for use. 47 CFR 90.675. Also, as per § 90.675, Public Safety licensees will not be afforded the right to accept or reject the activation of a proposed 700 MHz station or to unilaterally require changes to the station's operating parameters. We note as well that 700 MHz licensees may regard their operating parameters as proprietary and if so, we encourage such licensees to use non-disclosure agreement whereby third parties will not be given access to such information. Failing that, the affected parties could seek a protective order from the Commission. *See* Digital Output Protection Technology and Recording Method Certifications, *Order* , 19 FCC Rcd 4735 (2004). *See also* 47 CFR 0.457, 0.459. We also encourage, but do not require, that such matters be submitted to arbitration, mediation, or other alternative dispute resolution mechanisms. 151 Public Safety licensees will also be required to provide information about any technical changes they plan to make to their systems. 152 *See* Improving Public Safety Communications in the 800 MHz Band, Consolidating the 800 and 900 MHz Industrial/Land Transportation and Business Pool Channels, Amendment of Part 2 of the Commission's Rules to Allocate Spectrum Below 3 GHz for Mobile and Fixed Services to Support the Introduction of New Advanced Wireless Services, including Third Generation Wireless Systems, Petition for Rule Making of the Wireless Information Networks Forum Concerning the Unlicensed Personal Communications Service, Petition for Rule Making of UT Starcom, Inc., Concerning the Unlicensed Personal Communications Service, Amendment of Section 2.106 of the Commission's Rules to Allocate Spectrum at 2 GHz for use by the Mobile Satellite Service, WT Docket 02-55, ET Docket Nos. 00-258 and 95-18, RM-9498, RM-10024, *Report and Order, Fifth Report and Order, Fourth Memorandum Opinion and Order, and Order* , 19 FCC Rcd 14969, 15038-39 ¶ 125
(2004)(“ *800 MHz Report and Order* ”) (“if the characteristics of a proposed new cell are known in advance, it is possible to analyze the cell's potential for interference and make any necessary revisions to cell parameters before the cell is activated”), 15039 ¶ 127. 107. *Application of Secondary Markets Spectrum Leasing Policies and Rules to the Guard Bands.* Although the *Report and Order* replaces the Guard Band Manager spectrum leasing regime with the Secondary Markets spectrum leasing policies and rules, it sustains the requirements that applied to the Guard Band Manager regime with respect to the necessity to file annual reports with the Commission on spectrum use, as well as mandatory coordination with public safety entities for all uses of spectrum including that procured through leasing arrangements. The *Report and Order* also eliminates restrictions that had prevented Guard Band licensees from using their spectrum as system operators, and from leasing any more than 49.9 percent of their spectrum to affiliates. F. Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered 108. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives:
(1)The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(2)the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities;
(3)the use of performance, rather than design, standards; and
(4)an exemption from coverage of the rule, or any part thereof, for small entities. 153 153 5 U.S.C. 603(c). 109. In the *700 MHz Commercial Services Notice* , the Commission invited comment on extending the license terms of 700 MHz Band licenses to an expiration date beyond 2015 in order to afford licensees a sufficient period of time for deployment of new 700 MHz Band services once the DTV transition is complete. In addition, the *Notice* sought comment on whether the power limits in the existing rules for the 700 MHz Band spectrum should be revised. Finally, the Commission sought comment on its tentative conclusion that services provided in the 700 MHz Band, and in other bands subject to part 27 of the rules such as AWS-1, should be subject to E911 and hearing aid-compatibility requirements to the same extent that such services would be covered if provided in other bands, and on whether such requirements should be extended to all similar wireless services. 110. *Small Geographic Service Areas.* A number of small and rural service providers, as well as several different coalitions of small, regional, and rural carriers proposed a mix of service areas that would include 12 REAGs, 176 EAs, and 734 CMAs, instead of just six EAGs. Several national carriers filed comments in support of leaving the EAG pattern in place. Separate comments were also received seeking a nationwide license and license areas smaller than CMAs. 111. The Commission concluded that providing a mix of CMAs, EAs, and REAGs licenses in the 700 MHz Commercial Services spectrum will be an effective means of providing increased access to spectrum, especially in rural areas, while simultaneously meeting other Commission goals. The Commission agrees with those commenters who observe that a revised mix of smaller license sizes would provide a more balanced set of initial licensing opportunities at this time and make available more licenses to match the needs of different potential users. 154 The most common recommendation made to the Commission by small and rural providers was that additional licenses be made available based on small geographic service areas. 155 Some of these commenters asserted in particular that the use of small geographic license areas provides an incentive for licensees to serve more rural communities, whereas licensing by large geographic license areas may allow licensees to meet their performance requirements only by serving the largest urban markets. 156 154 *See* Letter from Multiple Commenters to Marlene H. Dortch, Secretary, Fedeal Communications Commission, WT Docket No. 06-150 (filed October 20, 2006) (“Balanced Consensus Plan”) (signatories to the Balanced Consensus Plan are Alltel, Aloha, Blooston, C&W, ConnectME Authority, Corr, Dobson, Leap, Maine Office of Chief Information Officer, MetroPCS, NTCA, Nebraska PSC, North Dakota PSC, RCA, RTG, Union, US Cellular, Vermont et al., Vermont Telephone Company); U.S. Cellular Comments in WT Docket 06-150 at 3; Corr Comments in WT Docket 06-150 at 3; NTCA Comments in WT Dockets 06-150 at 5-6. 155 *See* Aloha Comments in WT Docket 06-150 at 3-6; Balanced Consensus Plan at attachment; Blooston Comments in WT Docket 06-150 at 2; C&W Reply Comments in WT Docket 06-150 at 2-3; Corr Comments in WT Docket 06-150 at 2-4; Dobson Comments in WT Docket 06-150 at 2-4; Howard/Javed Comments in WT Docket 06-150 at 9; Leap Comments in WT Docket 06-150 at 4, 5-6; MilkyWay Comments in WT Docket 06-150 at 1-6; NextWave Comments in WT Docket 06-150 at 2-6; NTCA Comments in WT Docket 06-150 at 6; OPASTCO Comments in WT Docket 06-150 at 2-3; RCA Comments at 4-8; RTG Comments in WT Docket 06-150 at 2; U.S. Cellular Comments in WT Docket 06-150 at 4. 156 *See* Corr Comments in WT Docket 06-150 at 4; RCA Comments in WT Docket 06-150 at 9-10. 112. *Power Limits and Public Safety Notification.* In this *Report and Order* , the Commission takes steps to address potential intermodulation (“IM”) to public safety operations in the 700 MHz band in a manner that minimizes the impact on commercial licensees in the Upper 700 MHz Band, including small businesses with commercial operations in this band. The Commission declines to impose any technical restrictions on Upper 700 MHz Commercial Services Band licensees to address potential IM interference to 700 MHz public safety operations. The Commission will, however, require Upper 700 MHz Commercial Services Band licensees and 700 MHz public safety entities, upon request from the other, to exchange information about their operating stations and systems. A reporting requirement triggered only by a request of a public safety entity operating on the 700 MHz Band will minimize economic impact on small businesses operating in the commercial 700 MHz Band relative to the alternative of imposing potentially burdensome technical restrictions on Upper 700 MHz Commercial Services Band licensees to address potential IM interference to 700 MHz public safety operations. 113. *911/E911* . Almost all of the commenters addressing the 911/E911 issue support application of the 911/E911 requirements to services in the 700 MHz Commercial Services Band to the extent that those services are similar to the services already subject to the requirements. 157 Several commenters also state, however, that E911 should not apply to 700 MHz Commercial Services Band services to a greater extent than it does to services currently subject to the requirements. 158 157 *See* Aloha Comments in WT Docket 06-150 at 12; AT&T Comments in WT Docket 06-150 at 16; Blooston Comments in WT Docket 06-150 at 8; Cingular Comments in WT Docket 06-150 at 15; Dobson Comments in WT Docket 06-150 at 11; Leap Comments in WT Docket 06-150 at 11; NENA Comments in WT Docket 06-150 at 1-2; Qualcomm Comments in WT Docket 06-150 at 24 (supporting application of E911 to both auctioned and previously unauctioned spectrum); U.S. Cellular Comments in WT Docket 06-150 at 18 (same); TIA Comments in WT Docket 06-150 at 9-10; T-Mobile Reply at 6. 158 *See* Aloha Comments in WT Docket 06-150 at 12 (700 MHz licensees should be subject to the same E911 requirements, “no more or less,” as other licensees providing services where E911 obligations exist); Cingular Comments in WT Docket 06-150 at 15 (supporting application where services met the *E911 Scope Order* criteria); Qualcomm Comments at 24. 114. The Commission concludes that § 20.18(a) of its rules should be amended to apply 911/E911 requirements to all commercial mobile radio services (CMRS), including services licensed in the 700 MHz Commercial Services Band and the AWS-1 bands, to the same extent as they apply to wireless services currently listed in the scope provision of § 20.18. 159 For those small carriers who can demonstrate in a particular circumstance that implementation is not technically or economically feasible, the option of waiver relief is available. The *Report and Order* concludes, however, that such case-by-case circumstances, if any, should not delay the implementation of 911/E911 for service providers generally. In this regard, the Commission has observed previously that “911 service is critical to our Nation's ability to respond to a host of crises,” 160 and that E911 in particular “saves lives and property by helping emergency services personnel do their jobs more quickly and efficiently.” 161 The Commission also takes note of Congress's finding in the “Ensuring Needed Help Arrives Near Callers Employing 911 Act of 2004” that “for the sake of our Nation's homeland security and public safety, a universal emergency telephone number
(911)that is enhanced with the most modern and state-of-the-art telecommunications capabilities possible should be available to all citizens in all regions of the Nation” and that “enhanced 911 is a high national priority.” 162 159 *See* 47 CFR 20.18. 160 *See E911 Scope Order* , 18 FCC Rcd at 25341 ¶ 1. 161 *E911 Report and Order* , 11 FCC Rcd at 18678 ¶ 3, 18679 ¶ 5. 162 47 U.S.C. 942, notes (1), (4). 115. *Application of Secondary Markets Spectrum Leasing Policies and Rules to the Guard Bands* . The *Report and Order* maintains the existing requirement for Guard Band licensees to file annual reports regarding their spectrum usage, and thus does not increase the existing recordkeeping and reporting burden. Additionally, the *Report and Order* maintains the existing coordination requirements where all uses of Guard Bands spectrum must be coordinated with public safety operations in the 700 MHz Band. Under the *de jure* transfer leasing option within the Secondary Markets spectrum leasing policies and rules, the Guard Band licensee continues to be responsible for coordinating with the public safety operations. Under the *de facto* transfer leasing option, the lessee becomes primarily responsible for such coordination. As a result, to the extent that a Guard Band licensee is a small entity, the availability of the *de facto* transfer leasing option under the *Report and Order* reduces the overall potential burden on the Guard Band licensee, compared to its previous responsibility as a Guard Band Manager to coordinate all uses of its spectrum. G. Report to Congress 116. The Commission will send a copy of the *Report and Order* , including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. 163 In addition, the Commission will send a copy of the *Report and Order,* including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the *Report and Order* and FRFA (or summaries thereof) will also be published in the **Federal Register** . 164 163 *See* 5 U.S.C. 801(a)(1)(A). 164 *See* 5 U.S.C. 604(b). Ordering Clauses 117. Accordingly, *it is ordered* that pursuant to §§ 1, 4(i), 7, 10, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 251(e)(3), 301, 303, 307, 308, 309, 310, 311, 315, 316, 317, 324, 331, 332, 336, 337 and 710, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 157, 160, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 251(e)(3), 301, 303, 307, 308, 309, 310, 311, 315, 316, 317, 324, 331, 332, 336, 337, and 610, this *report and order* in WT Docket No. 06-150, CC Docket No. 94-102, WT Docket No. 01-309, WT Docket No. 03-264, WT Docket No. 06-169, WT Docket No. 96-86 and PS Docket No. 06-229 *is adopted* , and that part 1, part 20, part 27 and part 90 of the Commission's rules, 47 CFR part 1, 47 CFR part 20, 47 CFR part 27, and 47 CFR part 90, *are amended* as set forth in Rule changes. Effective May 16, 2007, except for the amendments to §§ 20.18(a), 27.50(c)(5), and 27.50(c)(8) which contain information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the **Federal Register** announcing the effective date. 118. *It is further ordered* that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, *shall send* a copy of this *report and order* , including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. 119. *It is further ordered* that the Commission *shall send* a copy of this *report and order* in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A). Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rules For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1, 20, 27 and 90 as follows: PART 1—PRACTICE AND PROCEDURE 1. The authority citation for part 1 continues to read as follows: Authority: 15 U.S.C. 79 *et seq.* ; 47 U.S.C. 151, 154(i), 154(j), 155, 157, 225, 303(r), and 309. 2. Section 1.955 is amended by revising paragraph (a)(1) to read as follows: § 1.955 Termination of authorizations.
(a)* * *
(1)*Expiration* . Authorizations automatically terminate, without specific Commission action, on the expiration date specified therein, unless a timely application for renewal is filed. *See* § 1.949 of this part. No authorization granted under the provisions of this part shall be for a term longer than ten years, except to the extent a longer term is authorized under § 27.13 of part 27 of this chapter. 3. Section 1.9005 is amended by revising paragraphs
(gg)and
(hh)and adding paragraph
(ii)to read as follows: § 1.9005 Included services.
(gg)The Common Carrier Fixed Point-to-Point Microwave Service (part 101 of this chapter);
(hh)The Multipoint Video Distribution and Data Service (part 101 of this chapter); and,
(ii)The 700 MHz Guard Bands Service (part 27 of this chapter). PART 20—COMMERCIAL MOBILE RADIO SERVICES 4. The authority citation for part 20 continues to read as follows: Authority: 47 U.S.C. 154, 160, 201, 251-254, 303, and 332 unless otherwise noted. 5. Section 20.18 is amended by revising paragraph
(a)to read as follows: § 20.18 911 service.
(a)*Scope of Section* . The following requirements are only applicable to CMRS providers, excluding mobile satellite service
(MSS)operators, to the extent that they:
(1)Offer real-time, two way switched voice service that is interconnected with the public switched network; and
(2)Utilize an in-network switching facility that enables the provider to reuse frequencies and accomplish seamless hand-offs of subscriber calls. These requirements are applicable to entities that offer voice service to consumers by purchasing airtime or capacity at wholesale rates from CMRS licensees. 6. Section 20.19 is amended by revising paragraphs
(a)and
(b)introductory text to read as follows: § 20.19 Hearing aid-compatible mobile handsets.
(a)*Scope of Section* . Providers of digital CMRS are subject to hearing aid-compatibility requirements to the extent that they:
(1)Offer real-time, two way switched voice or data service that is interconnected with the public switched network; and
(2)Utilize an in-network switching facility that enables the provider to reuse frequencies and accomplish seamless hand-offs of subscriber calls. Such providers are subject to the requirements set forth in this section to the extent that the established technical standard or standards specified in paragraph
(b)of this section are applicable to the service provided. This section also applies to the manufacturers of the wireless phones used in delivery of the services specified in this paragraph.
(b)*Technical standard for hearing aid compatibility* . The technical standard set forth in the standard document ANSI C63.19-2001 “American National Standard for Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids, ANSI C63.19-2001” (published October 8, 2001—available for purchase from the American National Standards Institute) is applicable to providers of Broadband Personal Communications Services (part 24, subpart E of this chapter), Cellular Radio Telephone Service (part 22, subpart H of this chapter), and Specialized Mobile Radio Services in the 800 MHz and 900 MHz bands (including in part 980, subpart S of this chapter). A wireless phone used for these services is hearing aid compatible for the purposes of this section if it meets, at a minimum: PART 27—MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES 7. The authority citation for part 27 continues to read as follows: Authority: 47 U.S.C. 154, 301, 302, 303, 307, 309, 332, 336, and 337 unless otherwise noted. § 27.4 [Amended] 8. Section 27.4 is amended by removing the definition of “Guard Band Manager.” 9. Section 27.10 is amended by revising the introductory paragraph to read as follows: § 27.10 Regulatory status. The following rules apply concerning the regulatory status in the frequency bands specified in § 27.5. 10. Section 27.13 is amended by revising paragraph
(b)to read as follows: § 27.13 License period.
(b)*698-764 MHz and 776-794 MHz bands* . Initial authorizations for the 698-764 MHz, 747-762 MHz, and 777-792 MHz bands, will extend for a term not to exceed ten years from February 17, 2009, except that initial authorizations for a part 27 licensee that provides broadcast services, whether exclusively or in combination with other services, will not exceed eight years. Initial authorizations for the 746-747 MHz, 776-777 MHz, 762-764 MHz, and 792-794 MHz bands shall not exceed January 1, 2015. Subsequent license terms shall be for a term not to exceed ten years. Licensees that initiate the provision of a broadcast service, whether exclusively or in combination with other services, may not provide this service for more than eight years or beyond the end of the license term if no broadcast service had been provided, whichever period is shorter in length. 11. Section 27.14 is amended by revising the section heading, redesignating paragraph
(e)as paragraph (f), and by adding new paragraph
(e)to read as follows: § 27.14 Construction requirements; Criteria for renewal.
(e)Comparative renewal proceedings do not apply to WCS licensees holding authorizations for the 698-746 MHz, 747-762 MHz, and 777-792 MHz bands. These licensees must file a renewal application in accordance with the provisions set forth in § 1.949 of this chapter. 12. Section 27.50 is amended by revising paragraphs
(b)and
(c)and Table 1 and adding new Table 2, Table 3, and Table 4 to read as follows: § 27.50 Power and antenna height limits.
(b)The following power and antenna height limits apply to transmitters operating in the 746-764 MHz and 776-794 MHz bands:
(1)Fixed and base stations transmitting a signal in the 746-747 and 762-764 MHz bands must not exceed an effective radiated power
(ERP)of 1000 watts and an antenna height of 305 m height above average terrain (HAAT), except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section;
(2)Fixed and base stations transmitting a signal in the 747-762 MHz and 777-792 MHz bands with an emission bandwidth of 1 MHz or less must not exceed an ERP of 1000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section;
(3)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 747-762 MHz and 777-792 MHz bands with an emission bandwidth of 1 MHz or less must not exceed an ERP of 2000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts ERP in accordance with Table 2 of this section;
(4)Fixed and base stations transmitting a signal in the 747-762 MHz and 777-792 MHz bands with an emission bandwidth greater than 1 MHz must not exceed an ERP of 1000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts/MHz ERP in accordance with Table 3 of this section;
(5)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 747-762 MHz and 777-792 MHz bands with an emission bandwidth greater than 1 MHz must not exceed an ERP of 2000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts/MHz ERP in accordance with Table 4 of this section;
(6)Licensees of fixed or base stations transmitting a signal in the 747-762 or 777-792 MHz bands at an ERP greater than 1000 watts must comply with the provisions set forth in paragraph (b)(8) of this section and § 27.55(c);
(7)Licensees seeking to operate a fixed or base station located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 747-762 MHz or 777-792 MHz bands at an ERP greater than 1000 watts must:
(i)Coordinate in advance with all licensees authorized to operate in the 698-764 MHz and 776-794 MHz bands within 120 kilometers (75 miles) of the base or fixed station; and
(ii)Coordinate in advance with all regional planning committees, as identified in § 90.527 of this chapter, with jurisdiction within 120 kilometers (75 miles) of the base or fixed station;
(8)Licensees authorized to transmit in the 747-762 or 777-792 MHz bands and intending to operate a base or fixed station at a power level permitted under the provisions of paragraph (b)(6) of this section must provide advanced notice of such operation to the Commission and to licensees authorized in their area of operation. Licensees who must be notified are all licensees authorized to operate in the 764-776 MHz and 794-806 MHz bands under part 90 of this chapter within 75 km of the base or fixed station and all regional planning committees, as identified in § 90.527 of this chapter, with jurisdiction within 75 km of the base or fixed station. Notifications must provide the location and operating parameters of the base or fixed station, including the station's ERP, antenna coordinates, antenna height above ground, and vertical antenna pattern, and such notifications must be provided at least 90 days prior to the commencement of station operation;
(9)Control stations and mobile stations transmitting in the 747-762 MHz band and the 776-794 MHz band and fixed stations transmitting in the 776-777 MHz band and the 792-794 MHz band are limited to 30 watts ERP;
(10)Portable stations (hand-held devices) transmitting in the 747-762 MHz band and the 776-794 MHz band are limited to 3 watts ERP;
(11)For transmissions in the 746-747 MHz, 762-764 MHz, 776-777 MHz, and 792-794 MHz bands, maximum composite transmit power shall be measured over any interval of continuous transmission using instrumentation calibrated in terms of RMS-equivalent voltage. The measurement results shall be properly adjusted for any instrument limitations, such as detector response times, limited resolution bandwidth capability when compared to the emission bandwidth, etc., so as to obtain a true maximum composite measurement for the emission in question over the full bandwidth of the channel; and
(12)For transmissions in the 747-762 MHz and 777-792 MHz bands, licensees may employ equipment operating in compliance with either the measurement techniques described in paragraph (b)(11) of this section or a Commission-approved average power technique. In both instances, equipment employed must be authorized in accordance with the provisions of § 27.51.
(c)The following power and antenna height requirements apply to stations transmitting in the 698-746 MHz band:
(1)Fixed and base stations transmitting a signal with an emission bandwidth of 1 MHz or less must not exceed an effective radiated power
(ERP)of 1000 watts and an antenna height of 305 m height above average terrain (HAAT), except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section;
(2)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal with an emission bandwidth of 1 MHz or less must not exceed an ERP of 2000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts ERP in accordance with Table 2 of this section;
(3)Fixed and base stations transmitting a signal with an emission bandwidth greater than 1 MHz must not exceed an ERP of 1000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts/MHz ERP in accordance with Table 3 of this section;
(4)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal with an emission bandwidth greater than 1 MHz must not exceed an ERP of 2000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts/MHz ERP in accordance with Table 4 of this section;
(5)Licensees seeking to operate a fixed or base station located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal at an ERP greater than 1000 watts must:
(i)Coordinate in advance with all licensees authorized to operate in the 698-764 MHz and 776-794 MHz bands within 120 kilometers (75 miles) of the base or fixed station;
(ii)Coordinate in advance with all regional planning committees, as identified in § 90.527 of this chapter, with jurisdiction within 120 kilometers (75 miles) of the base or fixed station;
(6)Licensees of fixed or base stations transmitting a signal at an ERP greater than 1000 watts and greater than 1000 watts/MHz must comply with the provisions of paragraph (c)(8) of this section and § 27.55(b), except that licensees of fixed or base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, must comply with the provisions of paragraph (c)(8) of this section and § 27.55(b) only if transmitting a signal at an ERP greater than 2000 watts and greater than 2000 watts/MHz;
(7)A licensee authorized to operate in the 710-716, 716-722, or 740-746 MHz bands, or in any unpaired spectrum blocks within the 698-746 MHz band, may operate a fixed or base station at an ERP up to a total of 50 kW within its authorized, 6 MHz spectrum block if the licensee complies with the provisions of § 27.55(b). The antenna height for such stations is limited only to the extent required to satisfy the requirements of § 27.55(b);
(8)Licensees intending to operate a base or fixed station at a power level permitted under the provisions of paragraph (c)(6) of this section must provide advanced notice of such operation to the Commission and to licensees authorized in their area of operation. Licensees who must be notified are all licensees authorized under this part to operate on an adjacent spectrum block within 75 km of the base or fixed station. Notifications must provide the location and operating parameters of the base or fixed station, including the station's ERP, antenna coordinates, antenna height above ground, and vertical antenna pattern, and such notifications must be provided at least 90 days prior to the commencement of station operation;
(9)Control and mobile stations are limited to 30 watts ERP;
(10)Portable stations (hand-held devices) are limited to 3 watts ERP; and
(11)Licensees may employ equipment operating in compliance with either the measurement techniques described in paragraph (b)(11) of this section or a Commission-approved average power technique. In both instances, equipment employed must be authorized in accordance with the provisions of § 27.51. Table 1.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 746-747 MHz and 762-764 MHz Bands and for Base and Fixed Stations in the 698-746 MHz, 747-762 MHz, and 777-792 MHz Bands Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 2.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-746 MHz, 747-762 MHz, and 777-792 MHz Bands Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000 Table 3.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-746 MHz, 747-762 MHz and 777-792 MHz Bands Transmitting a Signal With an Emission Bandwidth Greater Than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 4.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-746 MHz, 747-762 MHz and 777-792 MHz Bands Transmitting a Signal With an Emission Bandwidth Greater Than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000 13. Section 27.55 is amended by revising paragraph
(b)and adding new paragraph
(c)to read as follows: § 27.55 Power strength limits.
(b)*Power flux density limit for stations operating in the 698-746 MHz bands.* For base and fixed stations operating in the 698-746 MHz band in accordance with the provisions of § 27.50(c)(6), the power flux density that would be produced by such stations through a combination of antenna height and vertical gain pattern must not exceed 3000 microwatts per square meter on the ground over the area extending to 1 km from the base of the antenna mounting structure.
(c)*Power flux density limit for stations operating in the 747-762 and 777-792 MHz bands* . For base and fixed stations operating in the 747-762 and 777-792 MHz bands in accordance with the provisions of § 27.50(b)(6), the power flux density that would be produced by such stations through a combination of antenna height and vertical gain pattern must not exceed 3000 microwatts per square meter on the ground over the area extending to 1 km from the base of the antenna mounting structure. 14. Section 27.70 is added to read as follows: § 27.70 Information exchange.
(a)*Prior notification.* Public safety licensees authorized to operate in the 764-776 MHz and 794-806 MHz bands may notify any licensee authorized to operate in the 747-762 or 777-792 MHz bands that they wish to receive prior notification of the activation or modification of the licensee's base or fixed stations in their area. Thereafter, the 747-762 or 777-792 MHz band licensee must provide the following information to the public safety licensee at least 10 business days before a new base or fixed station is activated or an existing base or fixed station is modified:
(1)Location;
(2)Effective radiated power;
(3)Antenna height; and
(4)Channels available for use.
(b)*Purpose of prior notification.* The prior coordination of base or fixed stations is for informational purposes only. Public safety licensees are not afforded the right to accept or reject the activation of a proposed base or fixed station or to unilaterally require changes in its operating parameters. The principal purposes of notification are to:
(1)Allow a public safety licensee to advise the 747-762 or 777-792 MHz band licensee whether it believes a proposed base or fixed station will generate unacceptable interference;
(2)Permit 747-762 and 777-792 MHz band licensees to make voluntary changes in base or fixed station parameters when a public safety licensee alerts them to possible interference; and
(3)Rapidly identify the source if interference is encountered when the base or fixed station is activated. 15. The subpart heading for subpart F is revised to read as follows: Subpart F—Competitive Bidding Procedures for the 698-806 MHz Band 16. The subpart heading for subpart G is revised to read as follows: Subpart G—Guard Band Service (746-747/776-777 MHz and 762-764/792-794 MHz Bands) 17. Section 27.601 is revised to read as follows: § 27.601 Authority and coordination requirements.
(a)Subject to the provisions of § 27.2(b), a Guard Band licensee may allow a spectrum lessee, pursuant to a spectrum lease arrangement under part 1, subpart X of this chapter, to construct and operate stations at any available site within the licensed area and on any channel for which the Guard Band licensee is licensed, provided such stations comply with Commission Rules and coordination requirements.
(b)Subject to the provisions of § 27.2(b), a Guard Band licensee may allow a spectrum lessee, pursuant to a spectrum lease arrangement under part 1, subpart X of this chapter, to delete, move or change the operating parameters of any of the user's stations that are covered under the Guard Band licensee's authorization without prior Commission approval, provided such stations comply with Commission Rules and coordination requirements.
(c)*Frequency Coordination.*
(1)A Guard Band licensee, or a spectrum lessee operating pursuant to a spectrum lease arrangement under §§ 1.9030 and 1.9035 of this chapter, must notify Commission-recognized public safety frequency coordinators for the 700 MHz Public Safety band and adjacent-area Guard Band licensees within one business day after the licensee or the spectrum lessee has:
(i)Coordinated a new station or modification of an existing station; or
(ii)Filed an application for an individual station license with the Commission.
(2)The notification required in paragraph (c)(1) of this section must include, at a minimum—
(i)The frequency or frequencies coordinated;
(ii)Antenna location and height;
(iii)Type of emission;
(iv)Effective radiated power;
(v)A description of the service area, date of coordination, and user name or, in the alternative, a description of the type of operation.
(3)In the event a licensee partitions its service area or disaggregates its spectrum, it is required to submit the notification required in paragraph (c)(1) of this section to other Guard Band licensees in the same geographic area.
(4)Entities coordinated by a Guard Band licensee, or a spectrum lessee operating pursuant to a spectrum lease arrangement under §§ 1.9030 and 1.9035 of this chapter, must wait at least 10 business days after the notification required in paragraph (c)(1) of this section before operating under the license.
(d)Where a deletion, move or change authorized under paragraph
(b)of this section constitutes a discontinuance, reduction, or impairment of service under § 27.66 or where discontinuance, reduction or impairment of service results from an involuntary act subject to § 27.66(a), the licensee must comply with the notification and authorization requirements set forth in that section. 18. Section 27.602 is revised to read as follows: § 27.602 Lease agreements. Guard Band licensees may enter into spectrum leasing arrangements under part 1, subpart X of this chapter regarding the use of their licensed spectrum by spectrum lessees, subject to the following conditions:
(a)The spectrum lease agreement between the licensee and the spectrum lessee must specify in detail the operating parameters of the spectrum lessee's system, including power, maximum antenna heights, frequencies of operation, base station location(s), area(s) of operation, and other parameters specified in Commission rules for the use of spectrum identified in § 27.5(b)(1) and (b)(2).
(b)The spectrum lease agreement must require the spectrum lessee to use Commission-approved equipment where appropriate and to complete post-construction proofs of system performance prior to system activation. § 27.603 [Removed] 19. Section 27.603 is removed. § 27.605 [Removed] 20. Section 27.605 is removed. § 27.606 [Removed] 21. Section 27.606 is removed. 22. Section 27.607 is revised to read as follows: § 27.607 Performance requirements and annual reporting requirement.
(a)Guard Band licensees are subject to the performance requirements specified in § 27.14(a).
(b)Guard Band licensees are required to file an annual report providing the Commission with information about the manner in which their spectrum is being utilized. Such reports shall be filed with the Commission on a calendar year basis, no later than the March 1 following the close of each calendar year, unless another filing date is specified by Public Notice.
(c)Guard Band licensees must, at a minimum, include the following information in their annual reports:
(1)The total number of spectrum lessees;
(2)The amount of the licensee's spectrum being used pursuant to spectrum lease agreements;
(3)The nature of the spectrum use of the licensee's customers; and,
(4)The length of term of each spectrum lease agreement, and whether the agreement is a spectrum manager lease agreement, or a *de facto* transfer lease agreement.
(d)The specific information that licensees will provide and the procedures that they will follow in submitting their annual reports will be announced in a Public Notice issued by the Wireless Telecommunications Bureau. PART 90—PRIVATE LAND MOBILE RADIO SERVICES 23. The authority citation for part 90 continues to read as follows: Authority: Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7). 24. Section 90.555 is added to subpart R to read as follows: § 90.555 Information exchange.
(a)*Prior notification.* Public safety licensees authorized to operate in the 764-776 MHz and 794-806 MHz bands may notify any licensee authorized to operate in the 747-762 or 777-792 MHz bands that they wish to receive prior notification of the activation or modification of the licensee's base or fixed stations in their area. Thereafter, the 747-762 or 777-792 MHz band licensee must provide the following information to the public safety licensee at least 10 business days before a new base or fixed station is activated or an existing base or fixed station is modified:
(1)Location;
(2)Effective radiated power;
(3)Antenna height; and
(4)Channels available for use.
(b)*Purpose of prior notification.* The prior coordination of base or fixed stations is for informational purposes only. Public safety licensees are not afforded the right to accept or reject the activation of a proposed base or fixed station or to unilaterally require changes in its operating parameters. The principal purposes of notification are to:
(1)Allow a public safety licensee to advise the 747-762 or 777-792 MHz band licensee whether it believes a proposed base or fixed station will generate unacceptable interference;
(2)Permit 747-762 and 777-792 MHz band licensees to make voluntary changes in base or fixed station parameters when a public safety licensee alerts them to possible interference; and
(3)Rapidly identify the source if interference is encountered when the base or fixed station is activated.
(c)*Public Safety Information Exchange.*
(1)Upon request by a 747-762 or 777-792 MHz band licensee, public safety licensees authorized to operate radio systems in the 764-776 and 794-806 MHz bands shall provide the operating parameters of their radio system to the 747-762 or 777-792 MHz band licensee.
(2)Public safety licensees who perform the information exchange described in this section must notify the appropriate 747-762 or 777-792 MHz band licensees prior to any technical changes to their radio system. [FR Doc. E7-9334 Filed 5-15-07; 8:45 am] BILLING CODE 6712-01-P 72 94 Wednesday, May 16, 2007 Presidential Documents Part VIII The President Executive Order 13432—Cooperation Among Agencies in Protecting the Environment With Respect to Greenhouse Gas Emissions From Motor Vehicles, Nonroad Vehicles, and Nonroad Engines Title 3— The President Executive Order 13432 of May 14, 2007 Cooperation Among Agencies in Protecting the Environment With Respect to Greenhouse Gas Emissions From Motor Vehicles, Nonroad Vehicles, and Nonroad Engines By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: **Section 1.** *Policy* . It is the policy of the United States to ensure the coordinated and effective exercise of the authorities of the President and the heads of the Department of Transportation, the Department of Energy, and the Environmental Protection Agency to protect the environment with respect to greenhouse gas emissions from motor vehicles, nonroad vehicles, and nonroad engines, in a manner consistent with sound science, analysis of benefits and costs, public safety, and economic growth. **Sec. 2.** *Definitions* . As used in this order:
(a)“agencies” refers to the Department of Transportation, the Department of Energy, and the Environmental Protection Agency, and all units thereof, and “agency” refers to any of them;
(b)“alternative fuels” has the meaning specified for that term in section 301(2) of the Energy Policy Act of 1992 (42 U.S.C. 13211(2));
(c)“authorities” include the Clean Air Act (42 U.S.C. 7401-7671q), the Energy Policy Act of 1992 (Public Law 102-486), the Energy Policy Act of 2005 (Public Law 109-58), the Energy Policy and Conservation Act (Public Law 94-163), and any other current or future laws or regulations that may authorize or require any of the agencies to take regulatory action that directly or indirectly affects emissions of greenhouse gases from motor vehicles;
(d)“greenhouse gases” has the meaning specified for that term in Executive Order 13423 of January 24, 2007;
(e)“motor vehicle” has the meaning specified for that term in section 216(2) of the Clean Air Act (42 U.S.C. 7550(2));
(f)“nonroad engine” has the meaning specified for that term in section 216(10) of the Clean Air Act (42 U.S.C. 7550(10));
(g)“nonroad vehicle” has the meaning specified for that term in section 216(11) of the Clean Air Act (42 U.S.C. 7550(11));
(h)“regulation” has the meaning specified for that term in section 3(d) of Executive Order 12866 of September 30, 1993, as amended (Executive Order 12866); and
(i)“regulatory action” has the meaning specified for that term in section 3(e) of Executive Order 12866. **Sec. 3.** *Coordination Among the Agencies* . In carrying out the policy set forth in section 1 of this order, the head of an agency undertaking a regulatory action that can reasonably be expected to directly regulate emissions, or to substantially and predictably affect emissions, of greenhouse gases from motor vehicles, nonroad vehicles, nonroad engines, or the use of motor vehicle fuels, including alternative fuels, shall:
(a)undertake such a regulatory action, to the maximum extent permitted by law and determined by the head of the agency to be practicable, jointly with the other agencies;
(b)in undertaking such a regulatory action, consider, in accordance with applicable law, information and recommendations provided by the other agencies;
(c)in undertaking such a regulatory action, exercise authority vested by law in the head of such agency effectively, in a manner consistent with the effective exercise by the heads of the other agencies of the authority vested in them by law; and
(d)obtain, to the extent permitted by law, concurrence or other views from the heads of the other agencies during the development and preparation of the regulatory action and prior to any key decision points during that development and preparation process, and in no event later than 30 days prior to publication of such action. **Sec. 4.** *Duties of the Heads of Agencies* .
(a)To implement this order, the head of each agency shall:
(1)designate appropriate personnel within the agency to
(i)direct the agency's implementation of this order,
(ii)ensure that the agency keeps the other agencies and the Office of Management and Budget informed of the agency regulatory actions to which section 3 refers, and
(iii)coordinate such actions with the agencies;
(2)in coordination as appropriate with the Committee on Climate Change Science and Technology, continue to conduct and share research designed to advance technologies to further the policy set forth in section 1 of this order;
(3)facilitate the sharing of personnel and the sharing of information among the agencies to further the policy set forth in section 1 of this order;
(4)coordinate with the other agencies to avoid duplication of requests to the public for information from the public in the course of undertaking such regulatory action, consistent with the Paperwork Reduction Act (44 U.S.C. 3501 *et seq* .); and
(5)consult with the Secretary of Agriculture whenever a regulatory action will have a significant effect on agriculture related to the production or use of ethanol, biodiesel, or other renewable fuels, including actions undertaken in whole or in part based on authority or requirements in title XV of the Energy Policy Act of 2005, or the amendments made by such title, or when otherwise appropriate or required by law.
(b)To implement this order, the heads of the agencies acting jointly may allocate as appropriate among the agencies administrative responsibilities relating to regulatory actions to which section 3 refers, such as publication of notices in the **Federal Register** and receipt of comments in response to notices. **Sec. 5.** *Duties of the Director of the Office of Management and Budget and the Chairman of the Council on Environmental Quality* .
(a)The Director of the Office of Management and Budget, with such assistance from the Chairman of the Council on Environmental Quality as the Director may require, shall monitor the implementation of this order by the heads of the agencies and shall report thereon to the President from time to time, and not less often than semiannually, with any recommendations of the Director for strengthening the implementation of this order.
(b)To implement this order and further the policy set forth in section 1, the Director of the Office of Management and Budget may require the heads of the agencies to submit reports to, and coordinate with, such Office on matters related to this order. **Sec. 6.** *General Provisions* .
(a)This order shall be implemented in accordance with applicable law and subject to the availability of appropriations.
(b)This order shall not be construed to impair or otherwise affect the functions of the Director of the Office of Management and Budget relating to budget, administrative, and legislative proposals.
(c)This order is not intended to, and does not, create any right, benefit or privilege, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, instrumentalities, or entities, its officers or employees, or any other person. GWBOLD.EPS THE WHITE HOUSE, May 14, 2007. [FR Doc. 07-2462 Filed 5-15-07; 12:04 pm]
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  • 7 USC 8301-8317
  • 7 USC 1621-1627
  • 9 CFR 318.10(e)
  • 9 CFR 161
  • 9 CFR 317.4
  • 9 CFR 161.5
  • 7 USC 3801-3813
  • 9 CFR 166
  • 9 CFR 160
  • 7 CFR 3015
  • 7 CFR 1
  • 7 CFR 372
  • 9 CFR 149
  • 7 CFR 2.22
  • Pub. L. 104-13
  • Pub. L. 107-198
  • Pub. L. 106-113
  • 113 Stat. 2502
  • 5 USC 601-612
  • Pub. L. 104-121
  • 110 Stat. 857
  • 47 CFR 21.961(b)(1)
  • 47 CFR 24.720(b)
  • 47 CFR 90.814(b)(1)
  • 47 CFR 101
  • 47 CFR 74
  • 47 CFR 90.1103
  • 47 CFR 101.538(a)(2)
  • 47 CFR 101.538(a)(1)
  • 47 CFR 76.901(e)
  • 47 CFR 76.901(c)
  • 47 USC 43(m)(2)
  • 47 CFR 76.901(f)
  • 47 CFR 76.909(b)
  • 47 CFR 90
  • 47 CFR 95
  • 47 CFR 90.1-90
  • 47 CFR 27.14
  • 47 CFR 20.18(a)
  • 47 CFR 90.675
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