Amends TCA Title 53, Chapter 1; Section 53-7-202 and Section 53-7-220.
This bill revises, rearranges, and removes various provisions relating to the enforcement of the Tennessee Food, Drug and Cosmetic Act (TFDCA) as discussed below. ADULTERATED OR MISBRANDED ARTICLES Under present law, whenever a duly authorized agent of the commissioner finds, or has probable cause to believe, that any food, drug, device or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of the TFDCA, the agent must affix to the article a tag or other appropriate marking, giving notice that the article is, or is suspected of being, adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of the article by sale or otherwise until the permission is given by the agent or the court. This bill substitutes "marking" for "tagging". There are technical differences between the marking and tagging procedures, but the general purpose of identifying the articles as detained or embargoed and not to be used remains the same. Under present law, when an agent finds that a detained or embargoed article is not adulterated or misbranded, or if an agent fails to petition for an order of condemnation within 15 days of the detainer or embargo, the agent must remove the tag. Present law provides that failure of the agent to remove the embargo or detainer or to file a petition within the 15-day period triggers the right of interested persons to judicial review. This bill deletes the provision providing that an agent's failure to remove the embargo or detainer or file a petition within the 15-day period triggers the right of interested persons to judicial review. This bill removes a present law requirement that a person must post a bond to ensure proper processing or labeling of an adulterated or misbranded article as part of the process to redeem the article from destruction. This bill removes a present law provision that specifically requires the commissioner to immediately detain any depressant, stimulant, or hallucinogenic drug, or component thereof, as defined by rule, whenever the commissioner has reasonable grounds to believe that the articles are manufactured, held, transported or offered for sale as a violation TFDCA prohibited acts provision. The commissioner will remain any drug that is believed to be adulterated or so misbranded as to be dangerous or fraudulent. AUTHORITY TO PROMULGATE REGULATIONS This bill removes several requirements that the commissioner promulgate regulations on specific subjects but retains the commissioner's general rulemaking authority for the efficient enforcement of TFDCA. LICENSES AND PERMITS Under present law, no person may manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner. Present law lists various exceptions to the license requirement for persons who manufacture, process, pack, or hold foods for introduction into commerce, including: (1) When the person is not subject to any license or permit requirement under the provisions for: samplers and testers license; manufacturer plant and distributor licenses; license for establishment for slaughtering livestock, poultry, or deer; custom slaughterers license; and food establishment permits; and (2) When, prior to introducing the food into commerce, the person labels the food in accordance with the enforcement provisions and the regulations promulgated by the commissioner. This bill removes custom slaughterers licenses from item (1) above and requires in item (2) above that the person labeling such food do so in accordance with TFDCA. This bill does not delete the present law licensure requirement for custom slaughterers or change the provision of present law that defines "custom slaughterer" as a person engaged for profit in this state in the business of slaughtering or dressing animals for human consumption that are not to be sold or offered for sale through a commercial outlet. Under present law, subject to certain requirements, a license is not required for the operation of a farm to consumer distribution point. This bill deletes this provision. This bill removes specific authorization for the commissioner to issue temporary permits with special conditions for the manufacturing, processing, or packing of a class of food that may, by reason of contamination with micro-organisms, be injurious to health, but the injurious nature of which cannot be adequately determined after the food has entered commerce. ENFORCEMENT, FOOD STANDARDS, AND REPORTS Present law authorizes the commissioner to issue waning letters for minor violations of TFDCA and to refer more serious violations to district attorneys general for prosecution. Another provision of present law classifies violations of TFDCA as Class C misdemeanor offenses. This bill removes the provisions concerning warning letters and referrals to local district attorneys general. Present law requires the commissioner to promulgate reasonable standards of identity and definitions for food. Another provision of present law, which is scheduled to be repealed June 30, 2021, authorizes the department of agriculture to cooperate with the U.S. food and drug administration (FDA) on standards for the growing, harvesting, packing, and holding of produce for human consumption. This bill deletes the requirement that the commissioner promulgate standards of identity and removes the repeal date for the provision authorizing cooperation with the FDA. This bill removes specific authorization for the commissioner to publish reports concerning judgments, decrees, and court orders rendered under TFDCA and to disseminate information, regarding food, drugs, devices and cosmetics, that the commissioner deems necessary in the interest of public health and the protection of the consumer against fraud. ON MARCH 25, 2021, THE HOUSE SUBSTITUTED SENATE BILL 718 FOR HOUSE BILL 61, ADOPTED AMENDMENT #1, AND PASSED SENATE BILL 718, AS AMENDED. AMENDMENT #1 replaces references to "regulation" and "regulations" with references to "rule" and "rules" throughout the bill, as applicable.
This bill revises, rearranges, and removes various provisions relating to the enforcement of the Tennessee Food, Drug and Cosmetic Act (TFDCA) as discussed below. ADULTERATED OR MISBRANDED ARTICLES Under present law, whenever a duly authorized agent of the commissioner finds, or has probable cause to believe, that any food, drug, device or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of the TFDCA, the agent must affix to the article a tag or other appropriate marking, giving notice that the article is, or is suspected of being, adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of the article by sale or otherwise until the permission is given by the agent or the court. This bill substitutes "marking" for "tagging". There are technical differences between the marking and tagging procedures, but the general purpose of identifying the articles as detained or embargoed and not to be used remains the same. Under present law, when an agent finds that a detained or embargoed article is not adulterated or misbranded, or if an agent fails to petition for an order of condemnation within 15 days of the detainer or embargo, the agent must remove the tag. Present law provides that failure of the agent to remove the embargo or detainer or to file a petition within the 15-day period triggers the right of interested persons to judicial review. This bill deletes the provision providing that an agent's failure to remove the embargo or detainer or file a petition within the 15-day period triggers the right of interested persons to judicial review. This bill removes a present law requirement that a person must post a bond to ensure proper processing or labeling of an adulterated or misbranded article as part of the process to redeem the article from destruction. This bill removes a present law provision that specifically requires the commissioner to immediately detain any depressant, stimulant, or hallucinogenic drug, or component thereof, as defined by rule, whenever the commissioner has reasonable grounds to believe that the articles are manufactured, held, transported or offered for sale as a violation TFDCA prohibited acts provision. The commissioner will remain any drug that is believed to be adulterated or so misbranded as to be dangerous or fraudulent. AUTHORITY TO PROMULGATE REGULATIONS This bill removes several requirements that the commissioner promulgate regulations on specific subjects but retains the commissioner's general rulemaking authority for the efficient enforcement of TFDCA. LICENSES AND PERMITS Under present law, no person may manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner. Present law lists various exceptions to the license requirement for persons who manufacture, process, pack, or hold foods for introduction into commerce, including: (1) When the person is not subject to any license or permit requirement under the provisions for: samplers and testers license; manufacturer plant and distributor licenses; license for establishment for slaughtering livestock, poultry, or deer; custom slaughterers license; and food establishment permits; and (2) When, prior to introducing the food into commerce, the person labels the food in accordance with the enforcement provisions and the regulations promulgated by the commissioner. This bill removes custom slaughterers licenses from item (1) above and requires in item (2) above that the person labeling such food do so in accordance with TFDCA. This bill does not delete the present law licensure requirement for custom slaughterers or change the provision of present law that defines "custom slaughterer" as a person engaged for profit in this state in the business of slaughtering or dressing animals for human consumption that are not to be sold or offered for sale through a commercial outlet. Under present law, subject to certain requirements, a license is not required for the operation of a farm to consumer distribution point. This bill deletes this provision. This bill removes specific authorization for the commissioner to issue temporary permits with special conditions for the manufacturing, processing, or packing of a class of food that may, by reason of contamination with micro-organisms, be injurious to health, but the injurious nature of which cannot be adequately determined after the food has entered commerce. ENFORCEMENT, FOOD STANDARDS, AND REPORTS Present law authorizes the commissioner to issue waning letters for minor violations of TFDCA and to refer more serious violations to district attorneys general for prosecution. Another provision of present law classifies violations of TFDCA as Class C misdemeanor offenses. This bill removes the provisions concerning warning letters and referrals to local district attorneys general. Present law requires the commissioner to promulgate reasonable standards of identity and definitions for food. Another provision of present law, which is scheduled to be repealed June 30, 2021, authorizes the department of agriculture to cooperate with the U.S. food and drug administration (FDA) on standards for the growing, harvesting, packing, and holding of produce for human consumption. This bill deletes the requirement that the commissioner promulgate standards of identity and removes the repeal date for the provision authorizing cooperation with the FDA. This bill removes specific authorization for the commissioner to publish reports concerning judgments, decrees, and court orders rendered under TFDCA and to disseminate information, regarding food, drugs, devices and cosmetics, that the commissioner deems necessary in the interest of public health and the protection of the consumer against fraud. ON MARCH 25, 2021, THE HOUSE SUBSTITUTED SENATE BILL 718 FOR HOUSE BILL 61, ADOPTED AMENDMENT #1, AND PASSED SENATE BILL 718, AS AMENDED. AMENDMENT #1 replaces references to "regulation" and "regulations" with references to "rule" and "rules" throughout the bill, as applicable.
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