martes, 12 de marzo de 2013

A Proposed Rule by the Food and Drug Administration on 01/16/2013

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.

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