PROPOSED RULEMAKING
DEPARTMENT OF AGRICULTURE
[7 PA. CODE CHS. 3 AND 7]
Importation and Intrastate Transportation of Animals; Brucellosis
[30 Pa.B. 768] The Department of Agriculture (Department), under the specific authority conferred by the Domestic Animal Law (act), 3 Pa.C.S. §§ 2302, 2321, 2323 and 2325 proposes to amend §§ 3.103, 7.1, 7.47 and 7.72--7.74. These proposed amendments are intended to update the Department's policy on diagnostic testing techniques used to detect the presence of Equine Infectious Anemia (EIA) and the use of vaccines intended for the prevention of Brucellosis. Section 2302 of the act (relating to finding, policy and purpose) states that ''animal health is a major economic interest in the Commonwealth.'' In addition, section 2302 of the act delineates the policy and purpose of the act. The policy of the act is to ''assure the health and welfare of animals kept in captivity, to prevent and control diseases . . . and to provide desirable management practices for the production, keeping and use of domestic animals.'' The purpose of the act is to ''give the department authority to implement this policy.'' Section 2321(a) of the act (relating to dangerous transmissible diseases) designates Brucellosis and EIA as dangerous transmissible diseases. Section 2321(e) of the act confers upon the Department the power to ''establish regulations addressing the specific . . . prevention, . . . testing, control and eradication measures which it determines are necessary with respect to any dangerous transmissible disease.'' Section 2325 of the act (relating to use of biologicals, antibiotics, genetic material, chemicals, diagnostic agents and other substances) further defines the Department's authority to prescribe testing techniques and regulate the use of vaccines. Section 2323 of the act (relating to health requirements) sets forth the Department's authority to establish health standards for the importation or intraState movement of domestic animals in this Commonwealth.
Background
EIA is an infectious disease of equines caused by a virus. The current regulation, in § 3.103 (relating to agar gel immunodiffusion blood test), require equidae imported into this Commonwealth to be negative to an agar gel immunodiffusion blood test (Coggins Test). While the Coggins Test is a proven and effective testing device for EIA, a new and reportedly as effective test has been developed. This new test is an enzyme linked immunosorbent assay test (commonly called the ELISA Test). The ELISA Test is a screening device that recognizes the presence of the virus responsible for EIA. The ELISA Test is widely used to test for the presence of viruses and foreign substances in equidae. It is a scientifically proven and accepted test and is used to screen equidae for EIA in surrounding states. The inability of the Commonwealth to accept the results of ELISA tests has placed it at a great disadvantage with regard to surrounding states. Horse owners who wish to transport their horses into this Commonwealth are required to have a Coggins Test administered and to wait for the results of that test even if they have proof of a negative ELISA Test for EIA. This delay discourages owners from breeding, racing or carrying on other activities economically beneficial to the Commonwealth and the equine industry in this Commonwealth. Given the fact that the ELISA Test has been shown to be an effective screening device for EIA, additional testing and the delays caused by it are unnecessary to protect the health of the equine population in this Commonwealth and are economically inefficient. Therefore, the Department proposes to amend Chapter 3 (relating to health requirements for importation and intrastate transportation of animals) to allow for the use and acceptance of both the Coggins Test and the ELISA Test. In addition, language will be added to allow the Department more flexibility to respond to continuing advances in science and medical technology.
Brucellosis is an infectious disease of animals and man that can cause premature birthing or miscarriages in animals and undulating or remittent fevers and joint swelling in humans. A recent advance in vaccine technology has rendered the current vaccine--Strain 19 brucella abortus (Strain 19)--prescribed by regulation obsolete and relatively inefficient in the management of this disease. Until recently, Strain 19 vaccine was the standard vaccine used to vaccinate for Brucellosis in the United States. While Strain 19 vaccine has served the domestic animal industry well, it has two disadvantages. Its major disadvantage is causing a significant number of animals to react positively to the standard Brucellosis tests. This disadvantage has limited Strain 19 vaccine's usefulness and has slowed eradication and control efforts. The second disadvantage suffered by Strain 19 vaccine is that it limits the age at which domestic animals can be vaccinated. A newly developed vaccine--Strain RB 51--is now available and approved for use. Strain RB 51 vaccine is reportedly as effective as Strain 19 vaccine and does not cause a reaction, or false positive, with the standard Brucellosis tests. In addition, Strain RB 51 will allow the Department to broaden the age range for vaccination of calves from the current 4 to 8 months of age range to a 4 to 12 months of age range. A prompt and expedited application of this new technology will provide increased protection to this Commonwealth's extensive cattle population and will decrease the costs incurred by the Department to administer additional tests when false positives occur. Therefore, the Department proposes that the use of Strain 19 be discontinued and that Strain RB 51 be used for the routine vaccination of cattle and any other species of domestic animal for which the vaccine is approved. In addition, language will be added to allow the Department more flexibility to respond to continuing advances in science and medical technology.
In the interest of continuing to carry out the policy of the act, to assure the health and welfare of domestic animals and thereby secure the economic well being of the domestic animal industry, the Department proposes to amend §§ 3.103, 7.1, 7.47 and 7.72--7.74 to effectuate the changes previously discussed.
The major features of the proposed amendments are summarized as follows:
Summary of Major Features
Proposed § 3.1 (relating to definitions) adds the definition of ''Pennsylvania State Veterinarian'' and ''Secretary.'' These terms are recurring terms in this chapter and needed to be defined in order to add clarity.
The proposal to § 3.103 (relating to Agar gel immunodiffusion blood test) changes the heading to read ''Test methods.'' This section sets forth the acceptable testing techniques and the documentation required for importing equine into this Commonwealth. The amendments to this section allow the Department to accept the results of tests other than the Coggins Test. Specifically, the proposed amendments allow the Department to accept the results of the ELISA Test. In addition, the amendments allow the Secretary to designate other tests as acceptable through publication of an order in the Pennsylvania Bulletin. The Department would be required to amend the regulations to bring them into conformity with the order, within 1 year of the effective date of the order. A subsection was added to address the procedures to be followed in case of inconsistent test results.
Proposed § 7.1. (relating to definitions) adds and defines various recurring terms such as ''accredited veterinarian,'' ''Pennsylvania State Veterinarian'' and ''Secretary.''
Proposed § 7.47. (relating to herd additions) deletes the provision designating Strain 19 as the official vaccine to be used for Brucellosis vaccinations. In addition, it adds a sentence referencing Subchapter H (relating to vaccination), which designates a new vaccine, Strain RB 51, as the official vaccine to be used for Brucellosis vaccinations.
Proposed § 7.72. (relating to procedure) deletes the sentence in subsection (a) referencing Strain 19 and designates Strain RB 51 vaccine as the only Brucellosis vaccine authorized for use within this Commonwealth. In addition, the proposed amendments allow the Secretary to designate other vaccines as acceptable through publication of an order in the Pennsylvania Bulletin. The Department would be required to amend the regulations to bring them into conformity with the order, within 1 year of the effective date of the order. Subsection (b) is retitled and allows Strain 19 to be used with express written permission of the Pennsylvania State Veterinarian. Subsection (c) is retitled and expands the time period for an official vaccination. A subsection (d) was added and requires vaccinations to be administered by an accredited veterinarian. Subsection (e) is added and replaces existing subsection (c). This subsection was amended to allow veterinarians to charge for the cost of the vaccine as well as the cost of their services.
Proposed § 7.73. (relating to identification of calves) amendments to this section change and add to the identification requirements.
Proposed § 7.74. (relating to vaccination report) amendments to this section extend the time period in which reports must be submitted to the Department and reduces the number of copies of vaccination reports that are required to be sent to the Department.
Fiscal Impact
Commonwealth
The proposed amendments will impose minimal costs and have minimal fiscal impact upon the Commonwealth. The Commonwealth will realize a reduction in costs as a result of the use of Strain RB 51 vaccine. Strain 19 vaccine causes a number of cattle to test falsely positive each year. The cost of each false positive test is approximately $400 for the Commonwealth and $300 for the producer. These falsely positive tests will not occur in cattle vaccinated with Strain RB 51 vaccine. Savings relative to the ELISA Test are not easily quantified. However, acceptance of the ELISA test will eliminate the cost of performing a Coggins Test on animals which have already been screened for EIA through the use of an ELISA Test. The Department will benefit from not having to conduct additional testing. In addition, it will result in a decreased regulatory workload, since there will be fewer import violations to investigate and manage.
Political Subdivisions
The proposed amendments will impose no costs and have no fiscal impact upon political subdivisions.
Private Sector
The proposed amendments will impose minimal costs on private sector organizations and individuals. There will not be an increased cost to the regulated community. Cost of vaccinations will be essentially the same. Approximately 30 cattle test falsely positive each year. Each false positive case costs the farmer approximately $300 in special handling, early culling and reduced value of the animal. These costs will be eliminated with the use of Strain RB 51 vaccine. The proposed amendments will potentially affect approximately 1,800 accredited veterinarians who may be required to vaccinate calves for Brucellosis. However, these veterinarians, the Commonwealth and the industry would eventually be forced to use Strain RB 51 vaccine because the same company makes both the new and old vaccines and Strain 19 vaccine is being phased out of use throughout the United States. Adoption of the ELISA Test will not result in any increased cost. Pleasure horse and racehorse owners and trainers and equine veterinarians will be required to comply. However, the ELISA Test is accepted and used by a majority of states and therefore, the majority of owners, trainers and other persons in the equine industry already use and comply with ELISA testing. There is a potential savings in terms of the elimination of additional testing and reduced turnaround time for test results. In many cases, horse owners have been required to conduct the additional Coggins Test at their expense. Also, there have been instances when horses that were entered in a race were denied entrance to the track because of failure to meet the Commonwealth's rigid and unnecessary EIA requirements. These instances result in lost opportunities to race and to recoup training expenses.
General Public
The proposed amendments will impose no costs and have no fiscal impact on the general public. The farm community and the general public should benefit through reduced costs to the industry and the Commonwealth. The continued use of Strain 19 vaccine would result in continued low, but significant number, of false positive animals, which will continue to be a regulatory burden and expense to the cattle industry and the Department. Strain 19 vaccine can also cause infection in humans and is a health risk that veterinary practitioners have faced over the years. Delay in changing the EIA import requirements will perpetuate the ongoing problem of horses which are entered to race being turned away from the track, and will continue to impose an undue hardship on horse owners and the equine industry in this Commonwealth. The equine industry in this Commonwealth will benefit by coming into conformity with surrounding states with regard to accepted testing and screening techniques. Decreased costs and increased opportunities in both industries will benefit the general public.
Paperwork Requirements
The proposed amendments will not result in an appreciable increase of paperwork. The Department has already developed the appropriate forms and procedures to administer the EIA testing program and the Brucellosis vaccination program. Only small changes will be required.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 31, 2000, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Agriculture and Rural Affairs Committee and the Senate Agriculture and Rural Affairs Committee. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the agency in compliance with Executive Order 1996-1 ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, if IRRC has an objection to any portion of the proposed amendments, it will notify the Department within 10 days after the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulations, by the Department, the General Assembly and the Governor of objections raised.
Contact Person
Further information is available by contacting the Department of Agriculture, Bureau of Animal Health and Diagnostic Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408; Attn: Dr. Phillip Debok (717) 783-8555.
Effective Date
These proposed amendments would become effective upon publication in the Pennsylvania Bulletin.
SAMUEL E. HAYES, Jr.,
SecretaryFiscal Note: 2-128. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 7. AGRICULTURE
PART I. BUREAU OF ANIMAL HEALTH AND DIAGNOSTIC SERVICES
CHAPTER 3. HEALTH REQUIREMENTS FOR IMPORTATION AND INTRASTATE TRANSPORTATION OF ANIMALS
Subchapter A. GENERAL PROVISIONS § 3.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Pennsylvania State Veterinarian--The Director of the Bureau of Animal Health and Diagnostic Services of the Department.
* * * * * Secretary--The Secretary of the Department.
* * * * *
Subchapter D. IMPORTATION OF HORSES, MULES, ASSES AND OTHER EQUIDAE
EQUINE INFECTIOUS ANEMIA § 3.103. [Agar gel immunodiffusion blood test] Test methods.
(a) Testing required. Equidae imported into this Commonwealth for other than immediate slaughter shall be negative to [an] either of the following:
(1) An official agar gel immunodiffusion blood test (commonly called [The] the Coggins Test), conducted by a Federally-approved laboratory within 12 months prior to date of entry.
(2) An enzyme linked immuno sorbent assay test (commonly called the ELISA Test), conducted by a Federally-approved laboratory within 12 months prior to date of entry.
(b) Documentation required. A copy of the official test shall accompany the animal to its final destination.
[(b)] (c) Inconsistent results. If an equid receives more than one of the tests described in subsection (a), and one test shows a negative result and another a positive result, the equid may not be imported into this Commonwealth unless permission is granted by the Pennsylvania State Veterinarian.
(d) Designation of other tests as acceptable. If the Secretary determines that a test other than the tests described in subsection (a) is adequate to detect equine infectious anemia and is appropriate for use in equidae imported into this Commonwealth, the Secretary may so designate that test by publishing an order to that effect in the Pennsylvania Bulletin. The order shall take effect upon publication and the Department will, within 1 year of the effective date of that order, amend this section to bring it into conformity with the published order.
(e) Exception. Foals under 6 months of age, accompanied by dam with negative agar gel immunodiffusion test, a negative enzyme linked immunosorbent assay test or some other test approved by the Secretary and published in the Pennsylvania Bulletin, do not require a negative test.
CHAPTER 7. BRUCELLOSIS REGULATIONS
Subchapter A. GENERAL PROVISIONS § 7.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Accredited veterinarian--A licensed veterinarian jointly accredited by APHIS-USDA and the Department in the state the veterinarian is licensed to perform official duties on behalf of APHIS-USDA or the Department in the state the veterinarian is licensed to practice veterinary medicine. See accreditation standards established by 9 CFR Parts 160 and 161 (relating to definition of terms; and requirements and standards for accredited veterinarians; and suspension or revocation of such accreditation).
* * * * * Pennsylvania State Veterinarian--The Director of the Bureau of Animal Health and Diagnostic Services of the Department.
* * * * * Secretary--The Secretary of the Department.
* * * * *
Subchapter E. INDIVIDUAL CERTIFIED BRUCELLOSIS HERD PLAN § 7.47. Herd additions.
* * * * * (c) Animals officially vaccinated [with brucella abortus vaccine, Strain 19] in accordance with Subchapter H (relating to vaccination), and under 18 months of age, may enter a herd without a blood test but shall be accompanied by a health certificate.
Subchapter H. [CALFHOOD] VACCINATION § 7.72. Procedure.
(a) [Only accredited veterinarians selected by the owner may vaccinate female calves with Strain 19 brucella abortus vaccine.] Designation of vaccine. Strain RB 51 vaccine is hereby designated the only brucellosis vaccine authorized for use within this Commonwealth. If the Secretary determines that some other brucellosis vaccine is appropriate for use in cattle in this Commonwealth, the Secretary may so designate that vaccine by publishing an order to that effect in the Pennsylvania Bulletin. The order shall take effect upon publication and the Department will, within 1 year of the effective date of that order, amend this section to bring it into conformity with the published order.
(b) State veterinarian approval required. Strain 19 vaccine may only be used with the express written permission of the Pennsylvania State Veterinarian.
[(b)] (c) Official vaccination. An official vaccination shall consist of [an approved] Strain RB 51 vaccine administered to female calves from 4 through [8] 12 months of age ([120--269] 120--365 days). A vaccination of cattle over the age of 12 months (365 days) will not be considered an official vaccination unless done with the guidance and express written permission of the Pennsylvania State Veterinarian.
(d) Veterinarian to administer vaccine. An official vaccination may only be administered by an accredited veterinarian.
[(c)] (e) Veterinarian fees. Accredited veterinarians shall be permitted to charge the herd owner for [the cost of the services] their services and the vaccine.
§ 7.73. Identification of calves.
(a) Tattoo required. Veterinarians vaccinating calves shall tattoo [with] in the right ear the letter ''R'', followed by a United States Registered V Shield[, including ''V,'' in the right ear, preceded by the numeral of the quarter of the year and], followed by the last number of the year.
(b) Official state vaccination tag or official breed registry tattoo required. An orange official State vaccination tag shall be placed in the right ear. If the calf has an official breed registry tattoo, an official State vaccination tag is not required.
(c) Identification on vaccination report. Calves shall be identified on the vaccination report by [the] date of birth, official [Pennsylvania ear tag in the right ear,] State vaccination tag number and, or when applicable, their breed registration number or registration number of the dam.
§ 7.74. Vaccination report.
Vaccinations shall be reported to the Department within [7] 30 days following vaccination of the calves. The reports shall be made on forms provided by the Department. The original and [two copies] one copy shall be forwarded to the Department, one copy given to the herd owner for [his] the owner's records and one copy retained by the veterinarian.
[Pa.B. Doc. No. 00-240. Filed for public inspection February 11, 2000, 9:00 a.m.]
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