Chapter 228

2013 -- H 5597 SUBSTITUTE B

Enacted 07/11/13

 

A N A C T

RELATING TO ANIMALS AND ANIMAL HUSBANDRY -- BIOLOGICAL PRODUCTS

          

     Introduced By: Representatives DeSimone, Lima, Slater, and O'Brien

     Date Introduced: February 27, 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

United States department of agriculture are eligible for distribution in the state. All persons other

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 -- Sale or removal of

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 U.S. Department of Agriculture.

 

     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 Rhode Island, shall accompany the order for the

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.

     

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LC01504/SUB B

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