FDA defines the terms "small business" and
"very small business according to FSMA.
The Food and Drug Administration (FDA) is proposing to
amend its regulation for Current Good Manufacturing Practice In Manufacturing,
Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements
for domestic and foreign facilities that are required to register under the
Federal Food, Drug, and Cosmetic Act (the FD& C Act) to establish and
implement hazard analysis and risk-based preventive controls for human food.
FDA also is proposing to revise certain definitions in
FDA's current regulation for Registration of Food Facilities to clarify the
scope of the exemption from registration requirements provided by the
FD& C Act for “farms.”
FDA is taking this action as part of its announced
initiative to revisit the CGMPs since they were last revised in 1986 and to
implement new statutory provisions in the FD&C Act.
The proposed rule is intended to build a food safety
system for the future that makes modern, science-, and risk-based preventive
controls the norm across all sectors of the food system.
The Food and Drug Administration (FDA) Food Safety
Modernization Act (the FSMA) requires the Secretary of Health and Human
Services to promulgate regulations to establish science-based minimum standards
for conducting a hazard analysis, documenting hazards, implementing preventive
controls, and documenting the implementation of the preventive controls; and to
define the terms "small business" and "very small business."
The FSMA also requires the Secretary to promulgate
regulations with respect to activities that constitute on-farm packing or
holding of food that is not grown, raised, or consumed on a farm or another
farm under the same ownership and activities that constitute on farm
manufacturing or processing of food that is not grown, raised, or consumed on a
farm or another farm under the same ownership.
Source:
Federal Register https://www.federalregister.gov/articles/2013/01/16/2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human
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