Regulatory Brief

 Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations

​Formal Title: [Docket No. FDA-2013-N-1043] Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm

Brief Description:

The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled "Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm" (the draft RA).  The purpose of the draft RA is to provide a science-based risk anaylsis of those activity/animal food combinations that would be considered low risk.  FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.

Excerpt from the AVMA Response:

The AVMA advocates a science-based food safety system, and the use of risk analyses. Therefore, we applaud the use of the qualitative risk analysis by the FDA in developing regulations for implementing the Food Safety Modernization Act as described in the Federal Register docket No. FDA-2013-N-1043 to exempt certain low-risk activity and animal food combinations from the requirements. The AVMA appreciates the distinction between farms (that are not required to register) and farm mixed type facilities. Furthermore, we are pleased that the FDA recognizes within the risk assessment that nutrient imbalances are identified hazards in the production of animal food.

Background Documents:

Relevant AVMA Policy: