2013 -- H 5597 SUBSTITUTE B

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LC01504/SUB B

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2013

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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

     Referred To: House Corporations

It is enacted by the General Assembly as follows:

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     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

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Chapter 4-9 entitled "Biological Products" are hereby amended to read as follows:

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     4-9-1. Products to be labeled. -- All tuberculin, mallein, brucellosis vaccine, hog cholera

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serum, hog cholera virus, haemorrhagic, septicemiae aggressin, canine distemper vaccine or other

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biological products as defined under the Virus-Serum-Toxin Act 21 USC 151-159 et seq., used

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for the testing or immunizing of animals sold, given away, or used within the state shall bear a

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label, stating the name, and address of the person, firm, or institution making it, and the date of its

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preparation expiration and comply with all other provisions of the Virus-Serum-Toxin Act 21

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USC 151-159 et seq.

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     4-9-2. Monthly report of products sold or given away Authorization for distribution

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of products sold or given away. -- (a) Only products listed in section 4-9-1 and those that are

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either conditionally or unconditionally licensed by the center for veterinary biologics of the

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

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than duly licensed veterinarians selling or giving away intending to sell or give away any of the

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products listed in section 4-9-1 shall report monthly to the director of environmental management

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the amount of each product sold or given away, the degree of strength of the product, the name

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and address of the person to whom sold or given, and the date of delivery. The report shall also

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include the address of and be signed by the person making the report. notify, in writing, the

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director of the department of environmental management of their intent to sell or give away

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products enumerated in section 4-9-1. No later than ten (10) business days after receipt of the

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notification, the director of the department of environmental management shall provide a written

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response either authorizing or denying the sale or give away of the products identified in the

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notification. No person other than duly licensed veterinarians may sell or give away any of the

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products listed in section 4-9-1 until they have received written authorization by the director of

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the department of environmental management that they are allowed to sell or give away said

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products and that they are limited to selling and giving away said product in the manner in which

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the director approves, including, but not limited to, restrictions or conditions on the distribution,

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sale or use of the authorized product(s).

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     (b) Failure to obtain written authorization from the director prior to selling or giving

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away products enumerated in section 4-9-1 shall constitute a violation of this section. Failure to

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comply with the restrictions or conditions imposed by the director pursuant to subsection 4-9-2(a)

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shall constitute a violation of this section.

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     4-9-3. Use and disposition of products -- Records and reports. -- Persons buying or

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procuring any of the products listed in section4-9-1 shall not use or dispose of those products

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until assured, in writing, by the person from whom the tuberculin or biologics is received that its

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delivery to that person has been reported to the director of environmental management or unless

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they have themselves reported its receipt to the director, with information required to be furnished

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to those who distribute those products. Those persons buying or procuring those products shall

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keep a correct record of the amount used and the amount on hand, and shall report these facts

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whenever any of these products left on hand are not deemed fit for use, or are not to be used.

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Those persons shall forward the record and report to the director of environmental management,

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with a statement of where and when procured, the amount procured at the time, the amount used

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and his or her name and address. If the amount forwarded to the director of environmental

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management, and the amount used, do not equal the amount procured or purchased, a satisfactory

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statement shall be made as to what became of the remainder.

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     (a) The director of the department of environmental management may, as a condition of

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authorization provided in subsection 4-9-2(a), require records to be kept by persons that sell or

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give away any of the products enumerated in section 4-9-1. Such records may include, but not be

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limited to, the product trade name, the product generic name, the name and address of the

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company that produced the product, the USDA product code, the strength of the product, the date

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the product was produced, the date the product was delivered, the date the product was

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administered, the product serial number or lot number, the name and address of the owner of the

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animal(s) that the product was administered, sold, or given away to, and the individual

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identification of any animal(s) that the product was administered to or used on.

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     (b) Failure to keep records required by the director under this section shall constitute a

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violation of this section.

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     4-9-8. Treatment of animals to prevent normal reaction to tests -- Sale or removal of

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reactors. -- No person shall treat any animal with any material or substance nor in any manner

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for the purpose of preventing normal reaction on the part of the animal to the tuberculin mallein

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or other any diagnostic test. No person shall knowingly sell or offer for sale any animal that has

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reacted positively to the tuberculin mallein any USDA approved official tuberculosis test or the

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blood test for brucellosis. No animal that has reacted to the tuberculin mallein or any USDA

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approved official tuberculosis test other test shall be sold or removed from the premises where the

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test was made without permission, in writing, from the director of environmental management.

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     4-9-9. Penalty for violations of section 4-9-8 Penalty for violations. -- (a) Any person,

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firm or corporation willfully and knowingly violating subsections 4-9-2(b) or 4-9-3(b) shall be

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subject to a fine not to exceed one hundred dollars ($100).

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     (b) Any person, firm or corporation willfully and knowingly violating section 4-9-8 is

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guilty of a misdemeanor, and upon conviction shall be punished by a fine of not less than twenty-

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five dollars ($25.00) one hundred dollars ($100) nor more than one hundred dollars ($100) two

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hundred fifty dollars ($250), or by imprisonment for not less than one week nor more than

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exceeding six (6) months, or by both the fine and imprisonment, in the discretion of the court for

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the first offense; and not less than two hundred fifty dollars ($250), nor more than five hundred

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dollars ($500) or by imprisonment not exceeding six (6) months, or both, for each subsequent

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offense.

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     4-9-11. Federal approval of vaccines required. -- No vaccine or other biological

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product prepared for the purpose of immunizing animals shall be used in the state unless that

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product has been approved for that use by the biological division center of veterinary biologics of

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the U.S. Department of Agriculture.

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     SECTION 2. Sections 4-9-4, 4-9-5, 4-9-6 and 4-9-7 of the General Laws in Chapter 4-9

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entitled "Biological Products" are hereby repealed.

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     4-9-4. Orders for products containing living organisms. -- The selling, giving, or

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distribution of vaccines, or biological products containing living organisms to be used for the

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immunization of cattle against tuberculosis, glanders or other diseases is prohibited, except as

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provided. An order of a doctor of medicine or graduate veterinarian, who has been admitted by

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the representative state board to practice in Rhode Island, shall accompany the order for the

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material, with a statement containing the name and address of the owner of the animals it is

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proposed to treat and the object of the treatment and the doctor or veterinarian shall state over his

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or her signature that he or she will be personally responsible for the proper use of the vaccinating

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material or other biological products. The original of the order shall be kept on file by the vendor

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or distributor, and a copy of the order shall be filed by him or her with the director of

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environmental management.

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     4-9-5. Reports of receipt of products containing living organisms. -- The person, firm,

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or corporation shall report the receipt of the material to the director of environmental

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management along with a list of the animals it is proposed to treat, giving their ages and a

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description of each as will enable the director, or his or her representatives, to identify the

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animals.

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     4-9-6. Use of products containing live organisms. -- Further use of all vaccines and

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other biological products containing live organisms for the purpose of immunizing animals is

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restricted to approved veterinarians under strict supervision of the director of environmental

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management.

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     4-9-7. Penalty for inoculations without consent of director. -- It is unlawful for any

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person, without the consent, in writing, of the director of environmental management, to inoculate

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any animal in this state with the virus of any infectious or contagious disease incident to animals.

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Any person convicted of this offense shall be fined a sum not less than one hundred dollars

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($100) nor more than five hundred dollars ($500), in the discretion of the court.

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     SECTION 3 This act shall take effect upon passage.

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LC01504/SUB B

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO ANIMALS AND ANIMAL HUSBANDRY -- BIOLOGICAL PRODUCTS

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     This act would make a number of technical and definitional changes regarding the

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provisions of the general laws governing veterinary biologics, and would increase the penalty for

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violations.

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     This act would take effect upon passage.

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LC01504/SUB B

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