Sec. 2. Regulation of food produced using animal cell culture technology
672 words·~3 min read·
/bill/116/hr/5728/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq.) is amended by adding at the end the following: The Secretary shall regulate food intended for humans that is produced using animal cell culture technology derived from cell lines of animals other than livestock or poultry and, in coordination with the Secretary of Agriculture, food intended for humans that is produced using animal cell culture technology derived from cell lines of livestock or poultry.
Pursuant to subsection (a), the Secretary shall— conduct premarket consultation processes to evaluate production materials, processes, and manufacturing controls with respect to food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry and food intended for humans that is produced using animal cell culture technology, derived from cell lines of animals other than livestock or poultry, including oversight of tissue collection, cell lines, cell banks, and all components and inputs; oversee initial cell collection and the development and maintenance of qualified cell banks, including by issuing regulations or guidance and conducting inspections, as appropriate; oversee proliferation and differentiation of cells through the time of cell harvest, including by issuing regulations or guidance and conducting inspections, as appropriate; ensure that cell bank and cell culturing facilities comply with facility registration, applicable good manufacturing practices and preventive controls, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food; develop pursuant to notice and comment rulemaking additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe and not adulterated within the meaning of this chapter; conduct appropriate inspections and follow-up activities, including taking enforcement action if necessary, to ensure that cell bank and cell-culturing facilities are in compliance with applicable laws and regulations; coordinate the transfer of regulatory oversight of harvested cells derived from livestock or poultry to the Secretary of the Department of Agriculture during cell harvest, including providing such Secretary with any information necessary to determine whether harvested cells are eligible to be processed into food intended for humans that is produced using animal cell culture technology, derived from cell lines of livestock or poultry; inspect establishments that process, package, and label food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry; promulgate regulations regarding the safety and accurate labeling of food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry; and establish appropriate nomenclature for food intended for humans that is produced using animal cell culture technology, derived from cell lines other than livestock or poultry.
In carrying out this section, the Secretary shall share information, as appropriate, with the Department of Agriculture, including notifying the Department of Agriculture if objectionable conditions are identified at a facility carrying out any of the activities described in subsection (b), including conditions which may result in production of adulterated or misbranded food, collaborating with such department to address such conditions with respect to the harvesting of cell cultures, and rely on the Department of Agriculture to address such conditions with respect to processing, packaging, and labeling.
The Secretary shall not inspect activities of an establishment that are solely regulated by the Secretary of Agriculture. In this section— the term livestock means cattle, sheep, swine, goats, and fish of the order Siluriformes; and the term poultry means any domesticated bird, whether live or dead. Notwithstanding any other provision of law, the provisions of this section shall not derogate from any authority under the Federal Meat Inspection Act or Poultry Product Inspection Act, as in effect on the date of enactment of the Food Safety Modernization for Innovative Technologies Act , with respect to the regulation of meat and poultry produced in the traditional manner.
Nothing in this section shall be construed to authorize the Secretary to conduct an inspection of a farm. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 2
Regulation of food produced using animal cell culture technology
Cites 1Cited by 0 across 0 sources