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FDA Seeks Input on Appendix to Draft Qualitative Risk Assessment of Low-Risk Activity/Food Combinations

Tuesday, December 24, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is seeking comments by March 31 on a document entitled “Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.” The purpose of this document is to provide a science-based risk analysis of those foods whose production would be considered low risk with respect to the risk of intentional adulteration caused by acts of terrorism. The appendix supplements the science-based risk analysis included in the “Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm,” a document that the agency made available for public comment on Jan. 16, 2013, but which did not consider the risk of intentional adulteration caused by acts of terrorism.

The FDA will consider the results of this evaluation as part of its proposed rule on intentional adulteration to exempt or modify requirements for small or very small food facilities that are engaged only in specific types of on-farm food production identified in the draft qualitative risk assessment. 

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