4 TAC §34.1, §34.2
The Texas Animal Health Commission (TAHC) adopts amendments
to §34.1 and §34.2, concerning veterinary biologics. Section 34.2
is adopted with changes to the proposed text as published in the August 28,
1998, issue of the
Texas Register
(23 TexReg
8779). Section 34.1 is adopted without changes and will not be republished.
The amendments are being adopted to keep the rules in harmony with the
currently utilized vocabulary. Also, the rules will be more readily understood
and the intent of the rules will be clarified.
The following comments were received regarding adoption of the amendments.
Konrad Eugster, TVMDL, commented that Executive Director should be defined
as "A licensed Veterinarian who is the Executive Director of the Commission."
TAHC response: This was not done because the Commissioners did not think
specifying that the Executive Director must be a veterinarian was appropriate
under definitions for Veterinary Biologics.
Mr. Eugster commented "Salmonella arizonae is no longer the problem it
used to be 10-20 years ago."
TAHC response: this language has been deleted from §34.2(b)(2)(I)
and (b)(3)(B).
Mr. Eugster also commented "What would be the repercussion from removing
LT...from §57.10, reportable diseases? However, LT should remain in the
restricted biologics chapter (§34.2) just like MG."
TAHC response: Suggestion will be considered with Chapter 57 rewrite.
The amendments are adopted under the Texas Agriculture Code,
Chapter 161, §161.041(b) and §161.042, which authorizes the Commission
to promulgate rules in accordance with the Texas Agriculture Code.
§34.2. General Requirements.
(a)
Importation. Veterinary biologics produced under a regular
license issued by the USDA, APHIS, VS may be imported into the State of Texas,
however, prior to initial importation of any licensed veterinary biologic
for sale, use, or distribution within the state, written approval of the executive
director is required. The executive director may allow the importation of
unlicensed or conditionally licensed veterinary biologics when it is determined
necessary for the protection of humans or domestic animals or for research
purposes.
(b)
Restriction of biologics for disease control.
(1)
Rabies vaccines shall be sold, distributed, and administered
as prescribed by Chapter 826, Health and Safety Code, and rules adopted by
the Texas Board of Health.
(2)
All veterinary biologics used to control or diagnose
any of the following diseases listed in subparagraphs (A)-(K) of this paragraph
are restricted:
(A)
brucellosis;
(B)
equine infectious anemia;
(C)
equine viral arteritis;
(D)
hog cholera;
(E)
laryngotracheitis;
(F)
Mycoplasma gallisepticum (MG);
(G)
paratuberculosis;
(H)
pseudorabies;
(I)
tuberculosis;
(J)
vesicular stomatitis.
(3)
Restricted veterinary biologics may be purchased,
administered, or otherwise used under the following conditions listed in subparagraphs
(A)-(C) of this paragraph.
(A)
Laryngotracheitis (LT) chick embryo origin vaccine may
be used upon tentative or confirmed diagnosis by a recognized laboratory and
pursuant to a written agreement between the commission and the flock owners
in a designated area.
(B)
Mycoplasma gallisepticum (MG) attenuated vaccine may be
used upon confirmed diagnosis by a recognized laboratory, and where a written
permit for its use has been issued by the commission. MG vaccine may be used
without restriction following approval outlined in subsection (a) of this
section.
(C)
Other restricted veterinary biologics may be purchased,
administered, or otherwise used:
(i)
under the direct supervision of licensed veterinarians;
(ii)
by employees of the commission or USDA;
(iii)
by research agencies or laboratories as authorized by
the commission;
(iv)
in emergency disease control programs as authorized by
the commission; or
(v)
for other limited purposes authorized by the commission
and not likely to pose a threat to public health or to the health of animals.
(c)
Solicitation of information. The commission may solicit
information and recommendations on the following topics listed in paragraphs
(1)-(4) of this subsection prior to approving a veterinary biologic for sale,
use, or distribution within the state:
(1)
known effectiveness of the biologic;
(2)
to what extent the disease for which the veterinary
biologic is used or intended to be used is present in this state;
(3)
degree of isolation of the affected animals and area;
and
(4)
any other factor which may constitute a hazard to
animal or public health in this state.
(d)
Reporting. Any person using a veterinary biologic shall
report to the commission any suspected or actual disease outbreak or adverse
reaction that occurs in connection with use of the veterinary biologic.
(e)
Petition for review. Any person or entity may petition
the commission for a review of the sale and distribution of a veterinary biologic.
(f)
Appeal. Any person or other entity that receives an adverse
decision by the executive director on a request to sell, distribute, or use
veterinary biologics in this state may appeal such decision pursuant to the
provisions of the Administrative Procedure Act.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on March
1, 1999.
TRD-9901280
Dr. Max Coats
Deputy Executive Director for Animal Health Programs
Texas Animal Health Commission
Effective date: March 21, 1999
Proposal publication date: August 28, 1998
For further information, please call: (512) 719-0714