[26 Pa.B. 2184]
[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.]
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