Chapter 174
2013 -- S 0515 SUBSTITUTE A AS
AMENDED
Enacted 07/11/13
A N A C T
RELATING TO
ANIMALS AND ANIMAL HUSBANDRY -- BIOLOGICAL PRODUCTS
Introduced By: Senators Sosnowski, Ruggerio, Walaska, Kettle, and Cool Rumsey
Date Introduced: February 28, 2013
It is enacted by the
General Assembly as follows:
SECTION 1. Sections 4-9-1, 4-9-2, 4-9-3, 4-9-8, 4-9-9 and
4-9-11 of the General Laws in
Chapter 4-9 entitled
"Biological Products" are hereby amended to read as follows:
4-9-1.
Products to be labeled. -- All tuberculin, mallein, brucellosis vaccine, hog cholera
serum, hog cholera virus, haemorrhagic,
septicemiae aggressin,
canine distemper vaccine or other
biological products as defined under the Virus-Serum-Toxin
Act 21 USC 151-159 et seq., used
for the testing or immunizing of animals sold, given
away, or used within the state shall bear a
label, stating the name, and address of the person, firm,
or institution making it, and the date of its
preparation expiration
and comply with all other provisions of the Virus-Serum-Toxin Act 21
USC 151-159 et seq.
4-9-2. Monthly
report of products sold or given away Authorization for distribution
of products sold or given away. -- (a) Only products listed
in section 4-9-1 and those that are
either conditionally or unconditionally licensed by the
center for veterinary biologics of the
than duly licensed veterinarians selling or giving away intending to sell or
give away any of the
products listed in section 4-9-1 shall report monthly to
the director of environmental management
the amount of each product sold or given away, the degree
of strength of the product, the name
and address of the person to whom sold or given, and the
date of delivery. The report shall also
include the address of and be signed by the person making the
report. notify,
in writing, the
director of the department of environmental management of their
intent to sell or give away
products enumerated in section 4-9-1. No later than ten (10)
business days after receipt of the
notification, the director of the department of environmental
management shall provide a written
response either authorizing or denying the sale or give away
of the products identified in the
notification. No person other than duly licensed veterinarians may
sell or give away any of the
products listed in section 4-9-1 until they have received
written authorization by the director of
the department of environmental management that they are
allowed to sell or give away said
products and that they are limited to selling and giving away
said product in the manner in which
the director approves, including, but not limited to, restrictions
or conditions on the distribution,
sale or use of the authorized product(s).
(b) Failure to obtain
written authorization from the director prior to selling or giving
away products enumerated in section 4-9-1 shall constitute
a violation of this section. Failure to
comply with the restrictions or conditions imposed by the
director pursuant to subsection 4-9-2(a)
shall constitute a violation of this section.
4-9-3.
Use and disposition of products -- Records and reports. --
Persons buying or
procuring any of the products listed in section4-9-1 shall not
use or dispose of those products
until assured, in writing, by the person from whom the
tuberculin or biologics is received that its
delivery to that person has been reported to the director of
environmental management or unless
they have themselves reported its receipt to the director,
with information required to be furnished
to those who distribute those products. Those persons
buying or procuring those products shall
keep a correct record of the amount used and the amount on
hand, and shall report these facts
whenever any of these products left on hand are not deemed fit
for use, or are not to be used.
Those persons shall forward the record and report to
the director of environmental management,
with a statement of where and when procured, the amount
procured at the time, the amount used
and his or her name and address. If the amount forwarded
to the director of environmental
management, and the amount used, do not equal the amount
procured or purchased, a satisfactory
statement shall be made as to what became of the remainder.
(a) The director of
the department of environmental management may, as a condition of
authorization provided in subsection 4-9-2(a), require records to
be kept by persons that sell or
give away any of the products enumerated in section 4-9-1.
Such records may include, but not be
limited to, the product trade name, the product generic name,
the name and address of the
company that produced the product, the USDA product code, the
strength of the product, the date
the product was produced, the date the product was
delivered, the date the product was
administered, the product serial number or lot number, the name
and address of the owner of the
animal(s) that the product was administered, sold, or given
away to, and the individual
identification of any animal(s) that the product was administered to
or used on.
(b) Failure to keep
records required by the director under this section shall constitute a
violation of this section.
4-9-8. Treatment
of animals to prevent normal reaction to tests --
reactors. -- No
person shall treat any animal with any material or substance
nor in any manner
for the purpose of preventing normal reaction on the part
of the animal to the tuberculin mallein
or other any
diagnostic test. No person shall knowingly sell or offer for sale any
animal that has
reacted positively to the tuberculin mallein any USDA approved official tuberculosis test
or the
blood test for brucellosis. No animal that has reacted to the
tuberculin mallein or any USDA
approved official tuberculosis test other test shall be sold or removed from the premises
where the
test was made without permission, in writing, from the
director of environmental management.
4-9-9.
Penalty for violations of section 4-9-8 Penalty for violations.
-- (a) Any person,
firm or corporation willfully and knowingly violating
subsections 4-9-2(b) or 4-9-3(b) shall be
subject to a fine not to exceed one hundred dollars ($100).
(b) Any person,
firm or corporation willfully and knowingly violating section 4-9-8 is
guilty of a misdemeanor, and upon conviction shall be punished
by a fine of not less than twenty-
five dollars ($25.00) one hundred dollars ($100) nor more than one hundred dollars
($100) two
hundred fifty dollars ($250), or by imprisonment for not less than one
week nor more than
exceeding six (6) months, or by both the fine and
imprisonment, in the discretion of the court for
the first offense; and not less than two hundred fifty
dollars ($250), nor more than five hundred
dollars ($500) or by imprisonment not exceeding six (6)
months, or both, for each subsequent
offense.
4-9-11. Federal
approval of vaccines required. -- No vaccine or other biological
product prepared for the purpose of immunizing animals shall
be used in the state unless that
product has been approved for that use by the biological
division center of veterinary biologics of
the
SECTION 2. Sections 4-9-4, 4-9-5, 4-9-6 and 4-9-7 of the
General Laws in Chapter 4-9
entitled "Biological Products" are hereby repealed.
4-9-4. Orders
for products containing living organisms. -- The selling,
giving, or
distribution of vaccines, or biological products containing living
organisms to be used for the
immunization of cattle against tuberculosis, glanders
or other diseases is prohibited, except as
provided. An order of a doctor of medicine or graduate
veterinarian, who has been admitted by
the representative state board to practice in
material, with a statement containing the name and address of
the owner of the animals it is
proposed to treat and the object of the treatment and the
doctor or veterinarian shall state over his
or her signature that he or she will be personally
responsible for the proper use of the vaccinating
material or other biological products. The original of the
order shall be kept on file by the vendor
or distributor, and a copy of the order shall be filed
by him or her with the director of
environmental management.
4-9-5. Reports of
receipt of products containing living organisms. -- The person,
firm,
or corporation shall report the receipt of the material
to the director of environmental
management along with a list of the animals it is proposed to
treat, giving their ages and a
description of each as will enable the director, or his or her
representatives, to identify the
animals.
4-9-6.
Use of products containing live organisms. --
Further use of all vaccines and
other biological products containing live organisms for the
purpose of immunizing animals is
restricted to approved veterinarians under strict supervision of
the director of environmental
management.
4-9-7.
Penalty for inoculations without consent of director.
-- It is unlawful for any
person, without the consent, in writing, of the director of
environmental management, to inoculate
any animal in this state with the virus of any infectious
or contagious disease incident to animals.
Any person convicted of this offense shall be fined a sum
not less than one hundred dollars
($100) nor more than five hundred
dollars ($500), in the discretion of the court.
SECTION 3. This act shall take effect upon passage.
=======
LC01505/SUB A/2
=======