Title 7--AGRICULTURE DEPARTMENT OF AGRICULTURE [7 PA. CODE CH. 10] Pseudorabies Disease [26 Pa.B. 2184] The Department of Agriculture (Department) amends Chapter 10 (relating to pseudorabies disease). These amendments are adopted under the authority of section 1702 of The Administrative Code of 1929 (71 P. S. § 442), sections 3 and 9 of the act of April 17, 1929 (P. L. 533, No. 236) (3 P. S. §§ 343 and 349) and sections 4 and 6 of the act of March 28, 1929 (P. L. 110, No. 117) (3 P. S. §§ 374 and 376), which authorize the Department to take measures to detect, prevent, contain and eradicate dangerous transmissible diseases of animals within this Commonwealth, to establish quarantines necessary to pursue these objectives and to regulate in these areas.
Pseudorabies is a contagious infectious viral disease of animals. Although it poses no threat to human health, it threatens the economic well-being of the swine industry in this Commonwealth. Pseudorabies disease reduces swine production profit as a result of reproductive failures, diminished feed conversion efficiency and interstate restrictions on the movement of infected or exposed swine.
Pennsylvania swine producers, represented by the Pennsylvania Pork Producers Council and the Pennsylvania Purebred Swine Breeders Association, have petitioned the Department to provide resources and regulatory support to eliminate pseudorabies virus from this Commonwealth. These producers have established an Advisory Committee to coordinate their pseudorabies eradication efforts with the Department, other state departments of agriculture, the National Pork Producers Council and the United States Department of Agriculture.
The primary purpose of these amendments is to coordinate the Department's pseudorabies containment and eradication efforts with the industry-driven Pseudorabies Eradication State-Federal-Industry Program (Eradication Program) developed by the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) and set forth in USDA-APHIS publication no. 91-55-018, Pseudorabies Eradication State-Federal-Industry Program Standards.
These amendments amend existing authorities by adding provisions that require elimination of pseudorabies virus from infected premises, establish time frames for elimination of pseudorabies virus, provide for industry consultation and advice and in certain limited cases, provide for Department condemnation with indemnification of pseudorabies infected or exposed swine.
These amendments will allow Pennsylvania swine producers to systematically work through a five-stage State-Federal-industry prescribed process to achieve pseudorabies-free status. This will result in a more productive and profitable swine industry in this Commonwealth, and will facilitate the introduction of Commonwealth-produced swine into interstate and international commerce.
Compliance with Executive Order 1996-1, Regulatory Review and Promulgation
The Department reviewed this rulemaking and considered its purpose and likely impact in accordance with Executive Order 1996-1, Regulatory Review and Promulgation. This rulemaking addresses a compelling public interest, as described in this Preamble, and is otherwise in compliance with Executive Order 1996-1.
Comments
Notice of proposed rulemaking was published at 25 Pa.B. 4001 (September 23, 1995), and provided for a 30-day public comment period.
Comments were received from individual pork producers, the Pennsylvania State University College of Agricultural Sciences, a large-scale pork production operation, the House Agriculture and Rural Affairs Committee (House Committee) and the Independent Regulatory Review Commission (IRRC). Comments included concern for inadequate indemnity provisions, criticism of cost estimates of industry fiscal impact, recommendation for Department subsidy of vaccination costs, recommendations regarding appointment and consultation with an Advisory Committee and recommendations to clarify the regulations by altering the organization of the material and improving syntax. Response to these comments is organized by subject as follows.
Indemnity
The House Committee and IRRC requested an explanation of the Department's statutory authority to pay, or refrain from paying, indemnity with respect to swine depopulated from quarantined pseudorabies-exposed herds.
Pseudorabies is a dangerous transmissible disease of animals. The Department's authority to impose quarantines upon animals infected with pseudorabies, suspected of having pseudorabies, exposed to pseudorabies or susceptible to pseudorabies is set forth at sections 3 and 5 of the act of April 17, 1929.
Section 1702 of The Administrative Code of 1929 authorizes the Department to ''. . . take such measures as may seem advisable concerning methods of preventing, controlling and eradicating disease of animals, to cause the disinfection of any premises, and, when deemed necessary to prevent the spread of disease, to cause the destruction of animals . . .'' This provision gives the Department broad discretion to act with respect to pseudorabies in swine. The Department believes it a reasonable and necessary exercise of its statutory authority to quarantine pseudorabies-exposed swine herds, to require the development and implementation of herd-cleanup plans and, under certain circumstances in Stage 3 or higher, to condemn infected or exposed animals, or both.
The Department is not statutorily required to pay indemnity to the owners of swine who voluntarily depopulate their herds under herd-cleanup plans. The Department has, historically, exercised its authority under section 1702 of The Administrative Code of 1929 and paid indemnity only when animals have been condemned. Exercise of this authority has been limited to dangerous transmissible disease agents that threaten public health and which cannot reasonably be tolerated by the public or the industry. For example, in a recent outbreak of bovine tuberculosis the Department elected to pay the owner of a quarantined herd indemnity in exchange for the herd owner's agreement to destroy its tuberculosis-exposed animals. In this instance, the tuberculosis-exposed herd was the only known reservoir of bovine tuberculosis in this Commonwealth and the herd's destruction would be a major step forward in the Department's effort at protecting human health and regaining ''tuberculosis- free'' status for this Commonwealth.
The only situation where the payment of indemnity for swine is statutorily required, though, occurs when the Department condemns swine, as that term is defined in section 1 of the act of June 22, 1931 (P. L. 682), as amended (3 P. S. § 398).
In light of the foregoing, the Department concludes that although it may compensate the owner of quarantined pseudorabies test positive swine that are destroyed in accordance with a herd-cleanup plan, it is not obligated to pay indemnity since it has not condemned the animals in question.
Six commentators--the House Committee among them--offered comments to the effect that depopulation of pseudorabies test positive swine should be required in the absence of the payment of indemnity by the Department. Two of these commentators suggested the final amendments be revised to require the Department to pay indemnity whenever funds are available--regardless of the status of the particular herd-cleanup effort. One commentator suggested the General Assembly fund the Commonwealth's pseudorabies eradication effort as it funded the Avian Influenza eradication effort with respect to the Commonwealth's poultry industry several years ago. The commentator expressed an interest in eradicating pseudorabies in his infected swine herd, but reluctance to destroy his breeding stock which was '' . . . too expensive to sell to the butcher,'' unless he was adequately compensated.
The Department gave careful consideration to the propriety of condemning pseudorabies infected or exposed swine and concluded that, in the context of an industry-conceived and driven program, and in the absence of human health risk, it was inappropriate to adopt condemnation as a routine pseudorabies eradication program measure. The Department, however, recognized that special circumstances could occur which might necessitate or make highly desirable condemnation action. Provision in these amendments for indemnity refers only to the latter circumstances. In any case, ability to pay indemnity will depend on the availability of enabling funding.
IRRC suggested the definition of ''indemnity'' at § 10.1 (relating to definitions) be rephrased to state that indemnity may be equal to ''all or'' a portion of the appraised value of condemned swine. The Department declines to implement this suggestion. The Department believes it might be misleading to suggest that indemnity is intended to cover ''all'' of a recipient's losses. The Department believes that section 2 of the act of June 22, 1931 sets forth the indemnity rates that the Department should offer: no more than $300-per-swine; and the Department's contribution, together with salvage value and compensation received from other sources, may not exceed 90% of the appraised value of the animal.
IRRC recommended the initial paragraph of § 10.26 (relating to indemnity) be rephrased for greater clarity.
The Department accepts this suggestion, and has amended that paragraph accordingly.
A commentator recommended that § 10.26(a)(1) be revised to clarify that indemnity may be paid by the Department if, despite a herd owner's concerted effort to implement an official pseudorabies herd-cleanup plan, pseudorabies virus is not eliminated from the herd within a reasonable period of time.
The Department accepts this suggestion, and has revised § 10.26(a)(1) accordingly.
Fiscal Impact
Six commentators, the House Committee among others disagreed with statements in the Preamble and regulatory analysis form with respect to the proposed amendments indicating that the proposed amendments were not expected to impose additional costs on the private sector. The House Committee summarized the commentators' points of disagreement as follows:
The direct cost to individual producers subject to a herd-cleanup program will be substantial in the short term. The actual cost of a cleanup program, loss of income in the case of depopulation (both with or without indemnity), ''down time'' of a facility and other such actions all impose a cost on the individual producer. Likewise, additional recordkeeping and regulatory requirements impose an indirect cost on the entire industry.
In order to avoid confusion on the question of whether these regulatory revisions will impose additional costs upon producers, the Department has set forth a more detailed explanation in this Preamble under the heading addressing ''Fiscal Impact--Private Sector,'' and has revised Answer No. 22 on the Regulatory Analysis Form. The Department does not believe that these final-regulations will significantly increase the costs which a herd owner must bear. A number of considerations went into this conclusion, among them: the costs imposed on a herd owner by the mere presence of the pseudorabies virus in a swine herd, the costs that are imposed or could be imposed on a herd owner under the Department's current statutory and regulatory authority, the average turnover time of a swine herd and the additional costs that these final-regulations might impose.
The presence of pseudorabies virus in a swine herd imposes costs on the herd owner, regardless of whether the virus has been detected or not. Swine afflicted with the virus suffer higher reproductive failures and diminished feed conversion efficiency.
Under current statutory and regulatory authority, the Department places a special quarantine upon any swine herd within which pseudorabies exposure has been detected. This requirement is set forth at § 10.6 (relating to quarantine required). The circumstances under which a pseudorabies-related quarantine may be released are detailed at § 10.8 (relating to quarantine release) and include depopulation/disinfection requirements and specific testing regimens. These quarantine restrictions result in diminished product value and increased production costs.
Under the current regulation an owner of a quarantined pseudorabies-exposed swine herd faces the following options, and the costs associated with each: (1) allow the herd to remain under quarantine, obtaining permits as needed to move swine directly to slaughter; (2) depopulate the entire herd and disinfect the premises in accordance with § 10.8(c)(1); (3) depopulate only those animals that are positive to an official test for pseudorabies, and test the remaining exposed animals in accordance with § 10.8(c)(2); or (4) take other measures to demonstrate to a pseudorabies epidemiologist that the swine herd meets Federal quarantine release requirements. In short, these final regulations would remove only the first of the foregoing four options and compel the development and implementation of herd-cleanup plans in infected herds. It does not compel a particular method of herd-cleanup, but presents the herd owner with a number of options. These options are in accordance with guidelines established in the Eradication Program standards.
The Department agrees that there would be significant costs incurred by a herd owner who elects to completely depopulate his pseudorabies-exposed swine herd, disinfect the premises and allow a lapse of at least 30 days prior to herd repopulation, as described at § 10.8(c)(1). However, the amendments afford herd owners both the methodology and time (3 years) within which to accomplish herd- cleanup, with or without complete herd depopulation, with minimal resultant costs.
In many pseudorabies-exposed swine herds to date, the herd owner has opted for a method of herd-cleanup that involves the marketing of test positive animals and the systematic testing of the remaining animals, as described at § 10.8(c)(2) and (3). This allows the herd owner to make optimal use of the cycle of herd turnover. Swine herd populations are not static. The average life span of individual breeding animals in a swine herd is approximately 2.5 years; the average life span of swine fed for market is 5 to 6 months. Breeding replacement stock is obtained from herd progeny or by purchasing from outside sources.
Section 10.22(b)(2) (relating to objectives of plan) of the final regulations affords a herd owner 36 months, during Stage 3 of the Eradication Program, from the Department's approval of a herd-cleanup plan within which to eliminate pseudorabies virus from the herd. This 3-year period allows the herd-owner to utilize the 2.5 year herd turnover period, plus an additional 6 months, within which to systematically purge the herd of pseudorabies.
Under this herd cleanup plan, the herd owner would not be deprived of the value of his pseudorabies-infected swine. These animals are not marketable for purposes other than slaughter and the herd owner may market them for this purpose. If a particular test-positive swine had exceptional value as a breeding animal, and the herd owner is not immediately inclined to have this swine shipped to slaughter, he can segregate it from the herd and obtain the benefit of the swine's breeding value within the 36-month period for herd-cleanup plan completion. With respect to the swine that have been exposed to pseudorabies but are not pseudorabies test positive, the herd owner may continue to raise them within the herd. If these animals are ready for market while the herd quarantine remains in place, the herd owner may ship them to slaughter. Once the quarantine is lifted, the herd owner may dispose of swine as the owner deems appropriate. The only costs imposed by these final-regulations (as opposed to costs resulting from the presence of the pseudorabies virus within the herd or costs imposed under the current regulations) are the costs of testing, and these costs will be largely borne by the Department.
Several commentators offered general comments in support of these amendments.
A commentator from the Pennsylvania State University College of Agricultural Sciences states ''The general intent of the proposed rulemaking is worthwhile and timely. New regulations should be implemented . . .''
The same commentator opined that costs imposed by this regulation ''. . . should be far less than the cost to all Pennsylvania pork producers if the disease is not controlled or if interstate trade is adversely impacted because of the presence of . . . (pseudorabies virus) . . . in Pennsylvania.''
Another commentator from the Pennsylvania State University College of Agricultural Sciences stated that ''. . . there will be many circumstances in which the cost of eradicating the disease will outweigh the improvements in (swine) health and production.'' The commentator, while questioning the economic validity of embarking on a National pseudorabies eradication effort, supported the Eradication Program in light of its support among the industry and among owners of quarantined pseudorabies-exposed swine herds, the fact that neighboring states are further along in the five-stage cleanup process than the Commonwealth and the fact that Pennsylvania-produced feeder pigs are facing interstate marketing difficulties as a result. The commentator also observed that: ''. . . many producers in Pennsylvania have already eradicated the virus from their herds with the understanding that other quarantined herd owners would make similar efforts. In fairness to those cooperating producers and to those who have made significant investments to minimize the threat of pseudorabies, acceptance of these regulations is needed.''
In summary, the Department accepts the comments of the House Committee to the extent that a herd owner might incur some costs as a result of these final amendments if the owner opts for the total herd depopulation and disinfection procedures set forth at § 10.8(c)(1). These final regulations do not compel these procedures, though. A herd-cleanup plan may combine selective depopulation with selective herd repopulation, testing and monitoring procedures to allow the herd owner to systematically purge the owner's herd of pseudorabies during the natural herd turnover cycle. The final-regulations do not subject herd owners to any costs the owners were not already subject to under current regulatory authority.
Vaccine
One commentator suggested the Department distribute pseudorabies vaccine and initiate a thorough swine vaccination program in lieu of the procedures set forth in these final regulations.
The Department considered this proposal as it developed these amendments. Pseudorabies vaccine does not eliminate the pseudorabies virus within a swine herd nor does it prevent infection. Vaccine is useful in reducing virus shedding by infected animals and reduces the likelihood of spread within a herd or to other neighboring herds. The Department is aware of herd owners who used vaccination as the method of pseudorabies control within their swine herds and the Department has promoted the judicious use of vaccine. In most cases, vaccination alone was not enough to remove pseudorabies from the swine herd.
In addition, one of the goals of these final regulations is to bring the Commonwealth's pseudorabies eradication strategy in line with the Pseudorabies Eradication Program. That Program does not prescribe vaccination, by itself, to ensure pseudorabies eradication within a swine herd.
Although the Department believes that vaccination is a helpful tool in pseudorabies eradication, it must be used in combination with depopulation, sanitation measures and testing in order to achieve pseudorabies eradication within a swine herd. For the foregoing reasons, the Department declines to implement the suggestion that it use vaccination as the sole means by which to combat pseudorabies in swine.
Clarification
IRRC suggested the second sentence of the definition of ''indemnity'' at § 10.1 be relocated to § 10.26.
The Department accepts this suggestion, and has amended these sections accordingly.
IRRC also suggested the second sentence of the definition of ''official pseudorabies epidemiologist'' be relocated. The sentence at issue states that an official pseudorabies epidemiologist shall have special training in the diagnosis and epidemiology of pseudorabies, and otherwise meet the responsibilities of an ''official pseudorabies epidemiologist,'' as that term is defined in the Eradication Program standards.
The Department is not inclined to implement IRRC's suggestion. The reference to ''special training in the diagnosis and epidemiology of pseudorabies'' comes verbatim from the definition of ''official pseudorabies epidemiologist'' in the Eradication Program standards. The reference to meeting the responsibilities assigned an official pseudorabies epidemiologist under those Eradication Program standards helps to demonstrate to other jurisdictions that the Commonwealth's pseudorabies eradication efforts are in accordance with the Eradication Program standards, and apprises persons seeking or holding that designation of the necessity of being knowledgeable with respect to the Eradication Program standards.
IRRC further suggested the definition of ''official pseudorabies herd-cleanup plan'' be revised by deleting all but the first sentence and relocating the deleted material elsewhere in the final regulation. For the same basic reasons set forth in the preceding paragraph, the Department declines to implement this suggestion.
The definition at issue restates the definition of ''official pseudorabies herd-cleanup plan'' set forth in the Eradication Program standards, and emphasizes that the link between these definitions is intentional on the Department's part.
IRRC and another commentator expressed concern with the requirement that a herd owner develop and implement a pseudorabies herd-cleanup plan within 60 days (or some shorter specified time period) of receiving written notice from the Department directing this action. This requirement is set forth at § 10.21(a) (relating to plan requirements-development and implementation). IRRC stated it was not clear that a herd owner had to develop and implement a herd-cleanup plan within the 60-day period.
For greater clarity, the Department has replaced ''implement'' with ''put into effect'' in both §§ 10.21 and 10.25.
IRRC also recommended proposed § 10.21 be reworked to clarify the steps which the Department takes in reviewing proposed herd-cleanup plans and communicating its approval, disapproval or requests for additional information to the herd owner.
The Department accepts this recommendation, and has revised § 10.21(a) and (c) accordingly. A 15-day review period is established, and any time beyond this will not be credited against the 60 days within which a herd owner shall develop and put into effect an official pseudorabies herd-cleanup plan.
Two commentators recommended the Department require owners of quarantined pseudorabies-exposed swine herds within a particular region to develop and implement herd-cleanup plans at the same time. Presumably, this would decrease the risk that pseudorabies would spread from an infected herd with respect to which a herd-cleanup plan had not been implemented to a herd with respect to which a herd-cleanup plan had been implemented.
The Department accepts this recommendation. The Department will impose herd-cleanup requirements upon known pseudorabies-exposed swine herds at the same time.
IRRC noted the use of the term ''official pseudorabies herd-cleanup plan'' in § 10.22 (relating to objectives of plan) and suggested replacing that term with ''Department approved pseudorabies herd-cleanup plan.''
The Department is reluctant to deviate from the terminology set forth in the Eradication Program standards. These standards use the term ''official pseudorabies herd-cleanup plan.'' The overall purpose of the Eradication Program--to identify, contain and eliminate pseudorabies in swine Nationwide--is served by developing a common vocabulary among Federal and State animal health authorities. For these reasons, the Department elects to retain the term ''official pseudorabies herd-cleanup plan'' in the final amendments.
IRRC and several other commentators suggested that § 10.22(b)(2) (relating to objectives of plan) be revised by inserting the term ''cleanup plan'' in place of ''cleanup program.'' This revision would make subsection (b)(2) consistent with subsection (b)(1) and (3), both of which use the term ''cleanup plan,'' and with the definition of ''official pseudorabies herd cleanup plan'' at § 10.1.
The Department accepts this suggestion, and has amended § 10.22(b)(2) accordingly.
Advisory Committee
Several comments were received with respect to the composition and function of the Advisory Committee.
IRRC noted that proposed § 10.27(a) (relating to Advisory Committee) provided that the Secretary may appoint an Advisory Committee, and recommended that the final amendments use the word will instead.
The Department accepts this recommendation, and has amended § 10.27(a) accordingly.
Section 10.27(c), which describes Advisory Committee membership, does not specifically require that small-scale independent swine production operations be represented on that body. IRRC and three other commentators expressed concern over this fact. One commentator recommended the Advisory Committee contain producers who have successfully completed herd-cleanup plans. Another expressed skepticism that any nominee submitted by the Pennsylvania Pork Producers Council would adequately represent independent family producers who own pseudorabies-exposed swine herds. IRRC recommends the final amendments require independent family producer representation on the Advisory Committee.
The Department objects to the mandatory inclusion of a representative of small-scale independent family swine producers on the Advisory Committee, and notes that approximately 75% of the directors of the Pennsylvania Pork Producers Council are small or medium-sized independent producers. The Department has revised § 10.27(c)(2), though, to allow the Secretary of Agriculture greater discretion in selecting Advisory Committee members representing a fair cross-section of the Commonwealth's swine production industry. Nominees may be submitted by any person involved in the Commonwealth's swine production industry, or by any group representing that industry.
The House Committee, IRRC and another commentator took issue with the role assigned the Advisory Committee under the proposed amendments. The House Committee asked whether the Department should have the sole power to require herd-cleanup plans, impose sanctions and decide whether to pay indemnity for swine depopulated from pseudorabies-exposed herds in accordance with herd-cleanup plans. The House Committee suggested the consent and agreement of the Advisory Committee be obtained in these matters. In related comments, two other commentators recommended that the Advisory Committee, rather than the Department, have authority to deal with pseudorabies-exposed swine herds.
One of the purposes of the final-regulations is to bring the Department's pseudorabies control efforts into conformity with the Pseudorabies Eradication Program developed by USDA-APHIS. That Eradication Program prescribes the responsibilities of a state pseudorabies committee. These responsibilities are repeated almost verbatim in § 10.27(b). The Department prefers to rely entirely on the Eradication Program standards for guidance in establishing and relating to program measures.
Furthermore, in the absence of specific statutory authority, the Department has no authority to abdicate its responsibility for the identification, containment and eradication of pseudorabies, or its duty with respect to the expenditure of the funds appropriated it by the General Assembly for indemnity payments, in favor of the Advisory Committee.
Both IRRC and the House Committee requested clarification of the manner in which the Department will consult with the Advisory Committee.
The Department agrees that the proposed amendments were ambiguous in this regard. The Department has added a new § 10.27(f) to the final regulations, and has redesignated proposed subsection (f) as subsection (g) in the final amendments. When practicable, the Department will convene a meeting of the Advisory Committee to consult with respect to issues arising under §§ 10.25 and 10.27(b). If, in the Department's discretion, there is insufficient time within which to convene a meeting of the Advisory Committee, the Department will take necessary action and subsequently call a meeting or individually poll the members of the Advisory Committee regarding the question at issue. The presence or participation of more than half of the Advisory Committee members is necessary to constitute a quorum of that body. The majority vote of a quorum constitutes the position of the Advisory Committee on a given issue.
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[Continued from previous Web Page] Fiscal Impact
Commonwealth These amendments are expected to impose costs of approximately $15,000 on the Department in FY-1996, progressively decreasing to less than $4,000 in FY-1999.
Political Subdivisions These amendments will impose no costs and have no fiscal impact upon political subdivisions.
Private Sector These amendments will not increase the costs of compliance which were imposed upon the private sector under pre-existing regulatory authority. The sole exception might occur with respect to the owner of a quarantined pseudorabies-exposed swine herd who implements a herd-cleanup plan under which the entire herd is depopulated, the premises disinfected and left unoccupied by swine for at least 30 days prior to the reintroduction of swine. These costs are not readily measurable. The quarantined pseudorabies-exposed swine herds in this Commonwealth (approximately 50) may implement herd-cleanup plans that may not result in additional costs to the herd owner.
General Public These amendments will impose no costs and have no fiscal impact upon the general public.
Paperwork Requirements
These amendments are not expected to result in an appreciable increase in paperwork.
Contact Person
Further information is available by contacting the Department of Agriculture, Attention: Max A. Van Buskirk, Jr., Director, Bureau of Animal Industry, 2301 North Cameron Street, Harrisburg, PA 17110-9408.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)) the Department submitted a copy of the notice of proposed rulemaking published at 25 Pa.B. 4001 (September 23, 1995) on September 12, 1995, to IRRC and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs for review and comment. In compliance with section 5(b.1) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of the comments received, as well as other documentation.
In preparing these final-form regulations, the Department has considered all comments received from IRRC, the Committees and the public.
These final-form regulations were deemed approved by the House Committee on March 14, 1996, were deemed approved by the Senate Committee on March 14, 1996, and were approved by IRRC on March 21, 1996, in accordance with section 5(c) of the Regulatory Review Act.
Findings
The Department finds that:
(1) Public notice of intention to amend the regulations encompassed by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and that the comments received were considered.
(3) The modifications that were made to these regulations in response to comments received do not enlarge the purpose of the proposed amendments published at 25 Pa.B. 4001.
(4) The adoption of the amendments in the manner provided by this order is necessary and appropriate for the administration of the authorizing statute.
Order
The Department, acting under the authorizing statute, orders that:
(1) The regulations of the Department, 7 Pa. Code Chapter 10, are amended by amending §§ 10.1 and 10.8; and by adding §§ 10.21--10.27 to read as set forth in Annex A.
(2) The Secretary shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General for approval as required by law.
(3) The Secretary shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(4) This Order shall take effect upon publication in the Pennsylvania Bulletin.
CHARLES C. BROSIUS,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 26 Pa.B. 1603 (April 6, 1996).)
Fiscal Note: 2-91. (1) General Fund; (2) Implementing Year 1995-96 is $15,000; (3) 1st Succeeding Year 1996-97 is $15,000; 2nd Succeeding Year 1997-98 is $11,250; 3rd Succeeding Year 1998-99 is $7,500; 4th Succeeding Year 1999-00 is $3,750; 5th Succeeding Year 2000-01 is $3,750; (4) FY 1994-95 $514,282; FY 1993-94 $520,891; FY 1992-93 $811,425; (7) General Government Operations; (8) recommends adoption.
Annex A TITLE 7. AGRICULTURE PART I. BUREAU OF ANIMAL INDUSTRY CHAPTER 10. PSEUDORABIES DISEASE GENERAL § 10.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Advisory Committee--The State Pseudorabies Advisory Committee.
Animal--An equine or bovine animal, sheep, goat, pig, dog or cat and any wild animal under domestication and embryo, ova and semen.
Animal market--A place approved by the Department other than the farm of origin where animals are offered for sale, barter or trade, on a public, private or commercial basis.
Breeding swine--Sexually intact domestic swine 6 months of age or older, sexually intact feral swine of all ages, and sexually intact swine 5 months of age or younger selected for producing offspring.
Common ground--The ground, areas, building or equipment communally shared by any specific group of livestock.
Condemned--The status of a quarantined swine, swine product, conveyance or other quarantined article that has been determined by the Department as having been exposed to pseudorabies virus so that destruction of the swine, swine product, conveyance or other article is necessary to prevent the spread of pseudorabies.
Cooperative agreement--A document signed by the animal owner, attending veterinarian and Department regarding participation in a specific disease control program.
Department--The Department of Agriculture of the Commonwealth.
Eradication Program--The Pseudorabies Eradication State-Federal-Industry Program developed by USDA-APHIS and set forth in the Eradication Program standards.
Eradication Program standards--Those standards set forth in the USDA-APHIS publication bearing No. 91-55-018 and entitled ''Pseudorabies Eradication State-Federal-Industry Program Standards, effective January 1, 1994,'' or any applicable subsequent revision or codification thereof.
Farm of origin--A farm where the swine were born or the farm of most recent residence for at least 90 consecutive days immediately before movement.
Feeder swine--Domestic swine other than breeding swine.
Garbage--Putrescible animal and vegetable waste resulting from the handling, preparation, cooking and consumption of foods, including animal carcasses and parts thereof.
Herd--A group of livestock maintained on common ground for a purpose, or two or more groups of livestock between which members are interchanged regardless of separation.
Indemnity--Payment to the owner for a portion of the appraised value of condemned swine, swine products and other condemned articles that are slaughtered or destroyed by order of the Department to eradicate or prevent the spread of pseudorabies virus.
Licensed pseudorabies vaccine--A pseudorabies virus vaccine produced under license from the USDA-APHIS under the Virus, Serum and Toxin Act (21 U.S.C.A. §§ 151--159).
Official pseudorabies epidemiologist--A veterinarian employed by the Department or USDA-APHIS and designated by the Department and USDA-APHIS to investigate and diagnose suspected pseudorabies in animals. An official pseudorabies epidemiologist shall have special training in the diagnosis and epidemiology of pseudorabies, and shall otherwise meet the responsibilities of an ''official pseudorabies epidemiologist,'' as that term is defined in the Eradication Program standards.
Official pseudorabies herd-cleanup plan--A written plan to eliminate pseudorabies from a swine herd. The plan shall:
(i) Be developed by an official pseudorabies epidemiologist in consultation with the herd owner and his veterinary practitioner, if applicable.
(ii) Be mutually acceptable to those parties.
(iii) Be approved by the Department.
(iv) Otherwise be in conformance with the definition of ''official pseudorabies herd-cleanup plan,'' as that term is defined in the Eradication Program standards.
Owner-shipper statement--A statement signed by the owner or shipper of swine which states the following:
(i) The number of swine to be moved.
(ii) Official identification (complete eartag, tattoo or backtag number) of each swine.
(iii) The points of origin and destination.
(iv) The consignor and consignee.
(v) Additional information required by 9 CFR Part 85 (relating to pseudorabies).
Permit--A document issued by the Department or USDA-APHIS authorizing and establishing conditions under which a quarantined animal may be moved interstate or intrastate.
Pseudorabies--A contagious, infectious and communicable disease of animals caused by herpesvirus suis, also known as Aujeszky's disease, mad itch or infectious bulbar paralysis, that has been declared by the Department to be a dangerous transmissible disease.
Pseudorabies exposed animal--An animal that has been in contact with a pseudorabies infected animal. The term does not include an animal, other than swine, that has not been in contact for 10-consecutive days with an animal with symptoms of pseudorabies.
Pseudorabies restricted animal market--A quarantined animal market designated by the Department to conduct sales of swine originating from premises under Pennsylvania pseudorabies quarantine.
Pseudorabies test--A test for the diagnosis of pseudorabies approved by the Department that is conducted in a laboratory approved by the Department or USDA-APHIS to perform pseudorabies tests.
Pseudorabies vaccine--A product containing pseudorabies virus antigens.
Qualified pseudorabies negative herd--A swine herd enrolled in and in compliance with the qualified pseudorabies negative swine herd plan as defined in 9 CFR Part 85.
Quarantined feedlot--Premises where pseudorabies infected or exposed swine are fed and from which swine are moved by permit or owner shipper statement directly to a recognized slaughter establishment or directly through no more than one pseudorabies restricted animal market and then directly to a recognized slaughter establishment.
Quarantined herd--A herd in which pseudorabies infected or exposed swine are bred, reared or fed, and from which swine are moved only by permit directly to a recognized slaughter establishment or directly through no more than one pseudorabies restricted animal market and then directly to a recognized slaughter establishment.
Recognized slaughter establishment--A slaughter establishment operated under the Federal Meat Inspection Act (21 U.S.C.A. §§ 601--623, 641--645, 661, 671--680 and 691).
Secretary--The Secretary of the Department.
Stage I--The initial preparation stage of the Eradication Program, during which the basic procedures to control and eradicate pseudorabies are developed. This designation means that the Commonwealth has met the Stage I qualification standard set forth in the Eradication Program standards.
Stage II--The control stage of the Eradication Program, during which the Department participates on a cooperative basis with the Veterinary Services branch of USDA-APHIS to determine which herds are infected with pseudorabies and to begin herd-cleanup. This designation means that the Commonwealth, or a particular county thereof if so designated, has met the Stage II qualification standard set forth in the Eradication Program standards.
Stage III--The mandatory herd-cleanup stage of the Eradication Program, during which the cleanup of infected herds becomes mandatory and the Department, in consultation with the Advisory Committee, establishes time limits for developing and completing official pseudorabies herd-cleanup plans. This designation means that the Commonwealth, or a particular county thereof if so designated, has met the Stage III qualification standard set forth in the Eradication Program standards.
Stage IV--The surveillance stage of the Eradication Program, during which the Department monitors the Commonwealth, or any county thereof bearing this designation, to determine that cleanup programs have been effective, that any pseudorabies cases are attributable to importation of swine from out-of-State and that these outbreaks are contained. This designation means that the Commonwealth, or a particular county thereof if so designated, has met the Stage IV qualification standard set forth in the Eradication Program standards.
Stage V--The pseudorabies-free stage of the Eradication Program, during which the Commonwealth, or any county thereof bearing this designation, has been free of pseudorabies for at least 12 months and continues surveillance for cases of that disease. This designation means that the Commonwealth, or a particular county thereof if so designated, has met the Stage V qualification standard set forth in the Eradication Program standards.
USDA-APHIS--The United States Department of Agriculture, Animal and Plant Health Inspection Services.
§ 10.8. Quarantine release.
(a) Swine quarantined for noncompliance with importation health requirements shall be released from quarantine only when all importation requirements are met.
(b) Swine quarantined in accordance with § 10.6(c) (relating to quarantine required) may be released from quarantine when the swine are determined by the Department to be pseudorabies test negative.
(c) A quarantine imposed upon a pseudorabies infected swine herd may be released when one of the following conditions is met:
(1) The swine have been removed from the premises, the premises is thoroughly cleaned and disinfected with USDA-APHIS approved disinfection procedures in accordance with 9 CFR 85.12 and 85.13 (relating to cleaning and disinfecting means of conveyance; and cleaning and disinfecting livestock markets and other facilities) and swine have not been on the premises for 30 days or more.
(2) Swine positive to an official test for pseudorabies have been removed from the premises and exposed swine which remain in the herd are negative to two official pseudorabies tests. The first test may not be less than 30 days after the last positive swine has been removed from the premises and the second test not less than 60 days after the first test.
(3) Swine positive to an official test for pseudorabies have been removed from the premises and three successive random sample tests of the breeding herd and three successive random sample tests of other swine on the premises that are at least 4 months of age are negative for pseudorabies. The first test shall be done at least 30 days after removal of all positive swine; the second test shall be done at least 90 days after the first test and the third test shall be done at least 90 days after the second test. The number of swine composing a random sample for quarantine removal under this section is:
No. of swine in herd No. of swine to be tested 1--10 All 11--35 10 36 or more 30% or 30, whichever is less A random sample shall include all age groups including boars.
(4) An official pseudorabies epidemiologist has reviewed the herd history and determined the herd is free of pseudorabies and the swine herd meets quarantine release requirements in 9 CFR Part 85 (relating to pseudorabies).
(d) Animals, other than swine not exposed to an animal with symptoms of pseudorabies or a test positive animal for 10 days may be released from quarantine.
ERADICATION PROGRAM § 10.21. Plan requirements.
(a) Development and implementation. The Department will provide the owner of a pseudorabies swine herd with written notice of the time period within which an official pseudorabies herd-cleanup shall be developed and put into effect. This notice shall set forth the identity, address and telephone number of the official pseudorabies epidemiologist who shall consult with the herd owner in the development of the official herd-cleanup plan. The period within which the official pseudorabies herd-cleanup plan shall be developed and put into effect may be no longer than 60 days from the date upon which the owner receives the written notice. The herd owner shall promptly submit a proposed herd-cleanup plan to the Department.
(b) Subject matter. The Department may require that an official pseudorabies herd-cleanup plan address any activity relevant to the detection, containment or eradication of pseudorabies within the infected swine herd, as well as the surveillance and testing of the herd once it appears to be pseudorabies-free, regardless of whether the area of the Commonwealth within which the herd is located has been designated Stage I, Stage II, Stage III, Stage IV or Stage V.
(c) Review, approval and modification.
(1) An official pseudorabies herd-cleanup plan shall be approved by the Department prior to being put into effect.
(2) The Department will conduct its review of a proposed herd-cleanup plan within 15 days of receiving it, and will mail the Department's written approval, disapproval or request for additional information to the herd owner within that 15-day period.
(3) A written request by the Department for additional information shall toll the running of the 15-day period described in paragraph (2).
(4) Subsection (a) notwithstanding, if the Department fails to meet the 15-day deadline described in paragraphs (2) and (3), the development and implementation period described in subsection (a) will be extended by the number of days by which the Department exceeded its 15-day deadline.
(5) The Department may require that an official pseudorabies herd-cleanup plan be modified, and will provide the affected herd owner with advance notice of any required modifications in the manner set forth in this section.
§ 10.22. Objectives of plan.
(a) General objective. The general objective of an official pseudorabies herd-cleanup plan shall be to qualify all quarantined animals, premises and articles for release from quarantine.
(b) Specific objectives.
(1) The objective of an official pseudorabies herd-cleanup plan for a herd that is in an area of the Commonwealth designated Stage II shall be to prevent the further spread of pseudorabies within the herd and to take surveillance, sanitation and other measures toward eliminating pseudorabies from the herd.
(2) The objective of an official pseudorabies herd-cleanup plan for a herd that is in an area of this Commonwealth designated Stage III shall be to eliminate pseudorabies virus within the herd no later than 36 months after the Department approves the plan.
(3) The objective of an official pseudorabies herd-cleanup plan for a herd that is in an area of the Commonwealth designated Stage IV or Stage V shall be to eliminate pseudorabies virus in the herd no later than 6 months after the Department approves the plan.
§ 10.23. Monitoring the plan.
The Department will monitor the progress of an official pseudorabies herd-cleanup plan. This monitoring will be conducted at the Department's expense.
§ 10.24. Progress report.
The owner of a pseudorabies infected swine herd that is subject to an official pseudorabies herd-cleanup plan shall cooperate with the Department in the preparation by the Department of periodic progress reports. This cooperation includes making herd records available for inspection and presenting herd animals for physical inspection and testing by the Department or its authorized representatives during daylight hours or at some mutually-agreeable time.
§ 10.25. Consequences of noncompliance by herd owner.
If an owner of a pseudorabies infected swine herd has received the written notice described in § 10.21 (relating to plan requirements), yet fails to develop and put into effect an official pseudorabies herd-cleanup plan within the time period in that written notice, the Department may order mandatory depopulation of the herd, and may revoke or deny permits to move quarantined animals. The determination that an owner has failed to develop and put into effect an official pseudorabies herd-cleanup plan shall be made by the Department, which will consult with the Advisory Committee in accordance with § 10.27(f) (relating to Advisory Committee), in making this determination.
§ 10.26. Indemnity.
(a) The Department may offer indemnity if funds for indemnity are available, and may require the depopulation of a herd if it determines that one or more of the following apply:
(1) The herd owner has made a concerted effort to implement an official pseudorabies herd-cleanup plan, but has been unable to eliminate the pseudorabies virus from the herd within the applicable objective time in § 10.22(b) (relating to objectives of plan).
(2) Failure to depopulate the herd would unreasonably impede the progress or jeopardize the pseudorabies status of the Commonwealth under the Eradication Program.
(b) An indemnity payment need not equal and may not exceed the appraised value of the animal or article condemned by the Department.
§ 10.27. Advisory Committee.
(a) Establishment. The Secretary will appoint an Advisory Committee.
(b) Duties. It is the responsibility of the Advisory Committee to do the following:
(1) Inform and educate all segments of the Commonwealth's swine industry regarding pseudorabies eradication activities.
(2) Review the Eradication Program and make recommendations to the Department and to USDA-APHIS officials.
(3) Consult with the Department, as appropriate, on the subjects of Eradication Program budgeting, regulations, the use of vaccine and the Commonwealth's progress through the various stages of the Eradication Program.
(4) Maintain a liaison with other states and the National Pseudorabies Eradication Program through the National Pork Producers Council, the United States Animal Health Association, the Livestock Conservation Institute and USDA-APHIS.
(5) Perform the duties of a ''State pseudorabies committee,'' as that term is defined in the Eradication Program standards.
(c) Membership. The Secretary or a designee will be a member of the Advisory Committee. The Secretary will consider nominations for the Advisory Committee and will appoint the following:
(1) At least two but no more than four USDA-APHIS personnel from among nominees submitted by USDA- APHIS.
(2) At least six but no more than eight representatives of the Commonwealth's swine industry from among nominees submitted by persons engaged in the Commonwealth's swine industry or groups representing that industry.
(3) Two representatives of the Pennsylvania State University Extension Service.
(4) At least one but not more than two veterinary practitioners from among nominees submitted by the Pennsylvania Veterinary Medical Association.
(d) Terms. Appointed members of the Advisory Committee shall serve 2-year terms, and may be appointed to successive terms.
(e) Chairperson; meetings. At its first meeting of each calendar year, the Advisory Committee shall elect a chairperson, who shall serve in that capacity until the first meeting of the following calendar year or until his membership on the Advisory Committee ends, whichever occurs first. The Secretary or the chairperson may call meetings of the Advisory Committee, when appropriate.
(f) Consultation.
(1) If practicable, the Secretary will call and conduct a meeting of the Advisory Committee to consult that body on matters relating to the discharge of the Advisory Committee's duties under § 10.25 (relating to consequences of noncompliance by herd owner) and subsection (b).
(2) The presence of a majority of the Advisory Committee members shall constitute a quorum of the Advisory Committee. The majority vote of a quorum shall be considered the advice of the Advisory Committee.
(3) If the Department, in its discretion, determines a need for immediate action without first consulting the Advisory Committee, it will take action and, within 30 days thereof, the Secretary will call a meeting of the Advisory Committee or inform and poll that body regarding the action taken.
(g) Disbanding the Advisory Committee. The Secretary may disband the Advisory Committee if the EradicationProgram standards no longer require such a body as a condition of participation in the Eradication Program.
[Pa.B. Doc. No. 96-758. Filed for public inspection May 10, 1996, 9:00 a.m.]
