RULES AND REGULATIONS
Title 7--AGRICULTURE
DEPARTMENT OF AGRICULTURE
[7 PA. CODE CHS. 3 AND 7]
Health Requirements for Importation and Intrastate Transportation of Animals and Brucellosis
[30 Pa.B. 6187] The Department of Agriculture (Department), under the authority conferred by 3 Pa.C.S. §§ 2301--2389 (relating to Domestic Animal Law) (act) amends §§ 3.103, 7.1, 7.47 and 7.72--7.74 to read as set forth in Annex A.
Authority
The Department has the power and authority to amend and adopt these regulations. This authority includes:
(1) The general duty to implement the policy of section 2302 of the act (relating to finding, policy and purpose), which is to ''. . . assure the health and welfare of animals kept in captivity, to prevent and control diseases and dangerous substances that may threaten the safety of animals and humans, and to provide for desirable management practices for the production, keeping and use of domestic animals.''
(2) The general authority to regulate the keeping and handling of domestic animals to exclude or contain dangerous transmissible diseases and hazardous substances and to test and treat domestic animals exposed to or contracting a dangerous transmissible disease or hazardous substance as delineated in sections 2305 and 2329 of the act (relating to keeping and handling of domestic animals; and quarantine).
(3) The specific authority and duties conferred upon the Department by sections 2321, 2323 and 2325 of the act (relating to dangerous transmissible diseases; health requirements; and use of biologicals, antibiotics, genetic material, chemicals, diagnostic agents and other substances). Section 2321(a) of the act designates Brucellosis and Equine Infectious Anemia (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 further defines the Department's authority to prescribe testing techniques and regulate the use of vaccines. Section 2323 of the act sets forth the Department's authority to establish health standards for the importation or intrastate movement of domestic animals in this Commonwealth.
Need for the Rulemaking
These amendments are necessary to update the Department's policy on diagnostic testing techniques used to detect the presence of EIA and the use of vaccines intended for the prevention of Brucellosis. Section 2302 of the act states that ''animal health is of major economic interest in this 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 for desirable management practices for the production, keeping and use of domestic animals.''
EIA The EIA is an infectious disease of equines caused by a virus. The current regulations in § 3.103 (relating to test methods), require equidae imported into this Commonwealth, for other than immediate slaughter, 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. Such a delay discourages owners from breeding, racing or carrying on other activities economically beneficial to this 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, requiring a Coggins Test in addition to or instead of an ELISA Test 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 proposed to amend Chapter 3 to allow for the use and acceptance of both the Coggins Test and the ELISA Test.
Brucellosis 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--prescribed by regulation obsolete and relatively inefficient in the management of this disease. Until recently, Strain 19 brucella abortus (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 (false positives). 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 Stain RB 51 be used for the routine vaccination of cattle and any other species of domestic animal for which the vaccine is approved.
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 §§ 3.1, 3.103, 7.1, 7.47 and 7.72--7.74 to effectuate these changes referred to in this Preamble.
In summary, the Department is satisfied there is a need for the regulations, and that they are otherwise consistent with Executive Order 1996-1, ''Regulatory Review and Promulgation.''
Comments
Notice of proposed rulemaking was published at 30 Pa.B. 768 (February 12, 2000). The notice of proposed rulemaking did not contain a statement regarding the length of the public comment period. A notice, clarifying the length of the public comment period, providing that the public comment period was the statutorily required 30 days, was published at 30 Pa.B. 1255 (March 4, 2000).
Comments were received from the Independent Regulatory Review Commission (IRRC).
Comment: IRRC objected to two provisions of the proposed amendments, stating that the provisions were not consistent with the Department's statutory authority and the intent of the General Assembly. The sections objected to were §§ 3.103(d) and 7.72(a) (relating to test methods; and procedure). Both sections provide in whole or in part, that the Secretary may designate a new testing procedure or vaccine by publishing an order in the Pennsylvania Bulletin, provided the proposed rulemaking is published within 1 year of the order.
Response: Upon further review, the Department agrees with this objection and will delete any language regarding the Secretary's ability to designate a new test or vaccine through issuance and publication of an order in the Pennsylvania Bulletin. Although the Department believes it is inconsistent with the purpose of the act to require the Department to wait until regulations are published to approve and use a new and effective vaccine or testing technique which could eradicate, prevent or control diseases and thereby assure the health and welfare of domestic animals and humans, the regulatory provisions the Department seeks to amend implement section 2325 of the act, which requires the Department to promulgate regulations governing diagnostic agents and vaccines.
Comment: IRRC commented that §§ 3.103(c) and 7.72(c) need to be clarified. IRRC's concern is that neither section sets forth the procedure the regulated community must follow to comply with those sections of the regulations. IRRC suggested the regulations should outline the procedure to be followed or provide a cross reference to an existing regulation if there is one.
Response: The Department agrees with this comment. The Department has revised §§ 3.103(c) and 7.72(c) to address IRRC's concerns. A person seeking permission to import an equid with inconsistent tests results into this Commonwealth or seeking permission for the vaccination of cattle over the age of 12 months must do so in writing on a form provided by the Department, and must state the reasons for and facts relating to the request. The State Veterinarian will then provide a written approval or denial of the request. In addition, the Department has added the same language to § 7.72(b), which also required approval of the State Veterinarian.
Comment: IRRC had an additional comment, again concerning clarity, with regard to § 7.72(c) (relating to official vaccination). The language of the section states that a vaccination given to cattle over 12 months of age is not considered an official vaccination. IRRC suggested that the Department either cross reference the Federal code of regulations, at 9 CFR 78.1 (relating to definitions) or define ''official vaccination.''
Response: The Department agrees that the term ''official vaccination'' and what constitutes an ''official vaccination'' needs to be clarified. To clarify this term the Department has added three definitions to § 7.1 (relating to definitions). The Department defines ''official vaccination,'' ''official calfhood vaccination'' and ''adult vaccination.'' An ''adult vaccination'' may only be given and will only constitute an ''official vaccination'' with the express written permission of the State Veterinarian. The Department has also outlined the procedure for obtaining the express written permission of the State Veterinarian.
Comment: IRRC pointed out a typographical error in § 7.73(c). IRRC suggested the Department should delete ''or'' from the last sentence, leaving ''and'' in its place.
Response: This is not a typographical error. The identification on the vaccination report may be the official State vaccination tag, the breed registration number, the registration number of the dam or any combination thereof. The Department has changed the wording of the sentence to better reflect this intent.
Fiscal Impact
Commonwealth The final-form regulations 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 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 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 final-form regulations will impose no costs and have no fiscal impact upon political subdivisions.
Private Sector The final-form regulations 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 RB 51 vaccine. The amendments will potentially affect approximately 1,800 accredited veterinarians who may be required to vaccinate calves for brucellosis. However, these veterinarians, Pennsylvania and the industry would eventually be forced to use 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 Pennsylvania's rigid and unnecessary EIA requirements. The instances result in lost opportunities to race and to recoup training expenses.
General Public The final-form regulations 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 numbers, of false positive animals, which will continue to be a regulatory burden and expense to the cattle industry and the Department. Strain 19 brucellosis 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 final-form regulations 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.
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.
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 the notice of proposed rulemaking published at 30 Pa.B. 768 (February 12, 2000), to IRRC and to the Chairpersons of the House Agriculture and Rural Affairs Committee and the Senate Agriculture and Rural Affairs Committee for review and comment.
In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received, as well as other documentation. In preparing these final-form regulations, the Department has considered the comments received from IRRC, the Committees and the public.
Under section 5.1(d) of the Regulatory Review Act (71 P. S. § 745.5a(d)), these final-form regulations were deemed approved by the House and Senate Committees on October 4, 2000. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 19, 2000, and approved the final-form amendments.
Findings
The Department finds that:
(1) Public notice of its intention to adopt 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 their attendant regulations in 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments received were considered.
(3) The modifications that were made to these final-form regulations in response to comments received do not enlarge the purpose of the proposed rulemaking published at 30 Pa.B. 768.
(4) The adoption of the final-form regulations in the manner provided in this order is necessary and appropriate for the administration of the authorizing statute.
Order
The Department, acting under authority of the authorizing statute, orders the following:
(a) The regulations of the Department, 7 Pa. Code Chapters 3 and 7, are amended by amending §§ 3.1, 3.103, 7.1, 7.47 and 7.72--7.74 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Secretary of Agriculture shall submit this order and Annex A to the Office of General Counsel and to the Office of the Attorney General for review and approval as to legality and form, as required by law.
(c) The Secretary of Agriculture shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(d) This order shall take effect upon publication in the Pennsylvania Bulletin.
SAMUEL E. HAYES, Jr.,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 30 Pa.B. 5807 (November 4, 2000).)
Fiscal Note: Fiscal Note 2-128 remains valid for the final adoption of the subject regulations.
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 § 3.103. Test methods.
(a) Testing required. Equidae imported into this Commonwealth for other than immediate slaughter shall be negative to either of the following:
(1) An official agar gel immunodiffusion blood test (commonly called the Coggins Test), conducted by a Federally approved laboratory within 12 months prior to date of entry.
(2) An enzyme-linked immunosorbent 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.
(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.
(1) A person seeking permission shall do so in writing on a form provided by the Department setting forth the test dates, results of the tests and any other pertinent information.
(2) The Pennsylvania State Veterinarian may request additional information as may be necessary to assure the health of the animal and to prevent and control diseases and dangerous substances that may threaten the health and safety of animals and humans.
(3) The Pennsylvania State Veterinarian will provide a written approval or denial of a request within 3 working days of receiving the written request and all necessary information pertaining thereto.
(d) Exception. Foals under 6 months of age, accompanied by dam with negative agar gel immunodiffusion test or a negative enzyme-linked immunosorbent assay test 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. 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).
* * * * * Official adult vaccination--Strain RB 51 vaccine administered to female cattle or bison over the age of 12 months (365 days).
* * * * * Official calfhood vaccination--Strain RB 51 vaccine administered to female cattle or bison from 4 to 12 months of age.
* * * * * Official vaccination--An official calfhood or adult vaccination.
* * * * * 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.
(a) Additions to herds shall be accompanied with valid health charts and verified by an accredited veterinarian on the record of herd change and meet the requirements of Chapter 3, Subchapters B and I (relating to importation of cattle, goats and buffalo; and intrastate transportation of cattle, goats and buffalo).
(b) Progeny of the herd shall be accompanied with a signed statement by the owner and veterinarian indicating that these animals are progeny of the herd.
(c) Animals officially vaccinated 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. VACCINATION § 7.72. Procedure.
(a) Designation of vaccine. Except as authorized under subsection (b), Strain RB 51 vaccine is hereby designated the only brucellosis vaccine authorized for use within this Commonwealth.
(b) State Veterinarian approval required. Strain 19 vaccine may only be used with the express written permission of the Pennsylvania State Veterinarian. Requests for permission to administer Strain 19 vaccine shall be made in writing on a form provided by the Department.
(1) The Pennsylvania State Veterinarian may request additional information as may be necessary to assure the health of the animal and to prevent and control diseases and dangerous substances that may threaten the health and safety of animals and humans.
(2) The Pennsylvania State Veterinarian will provide a written approval or denial of a request within 3 working days of receiving the written request and the necessary information pertaining thereto.
(c) Official vaccination. An official vaccination shall consist of Strain RB 51 vaccine administered to female cattle or bison from 4 through 12 months of age (120-365 days). A vaccination of female cattle or bison 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. Requests to administer an official adult vaccination shall be made in writing on a form provided by the Department.
(1) The request shall set forth the reasons for the request, the vaccine to be administered and the age of the animal at the time of the request.
(2) The Pennsylvania State Veterinarian may request additional information as may be necessary to assure the health of the animal and to prevent and control diseases and dangerous substances that may threaten the health and safety of animals and humans.
(3) The Pennsylvania State Veterinarian will provide a written approval or denial of the request within 3 working days of receiving the written request and the necessary information pertaining thereto.
(d) Veterinarian to administer vaccine. An official vaccination may only be administered by an accredited veterinarian.
(e) Veterinarian fees. Accredited veterinarians shall be permitted to charge the herd owner for their services and the vaccine.
§ 7.73. Identification of officially vaccinated animals.
(a) Tattoo required. Veterinarians administering official calfhood or official adult vaccinations shall tattoo in the right ear of the animal the letter ''R,'' followed by a United States Registered ''V'' shield 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 vaccinated animal has an official breed registry tattoo, an official State vaccination tag is not required.
(c) Identification on vaccination report. Officially vaccinated animals shall be identified on the vaccination report by date of birth, and an official State vaccination tag, their breed registration number or registration number of the dam, or both.
§ 7.74. Vaccination report.
Vaccinations shall be reported to the Department within 30 days following vaccination of the animal. The reports shall be made on forms provided by the Department. The original and one copy shall be forwarded to the Department, one copy given to the herd owner for the owner's records and one copy retained by the veterinarian.
[Pa.B. Doc. No. 00-2057. Filed for public inspection December 1, 2000, 9:00 a.m.]
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