RULES AND REGULATIONS
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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