In the August 25, 2016, Federal Register, see here, here, and here, FDA announced the availability of three
draft guidance documents under FSMA. Two of the draft guidances,
"Human Food By-Products for Use as Animal
Food," and "Current Good Manufacturing Practice Requirements
for Food for Animals," are meant to assist domestic and
foreign companies in complying with human food by-product
requirements under the FSMA Preventive Controls for Animal Food
Rule, and with Current Good Manufacturing Practice
("CGMP") requirements. The third draft guidance "Classification of Activities as Harvesting,
Packing, Holding, or Manufacturing/Processing for Farms and
Facilities," is aimed at helping food businesses determine
which of the FSMA rules apply to their operations. Once finalized,
this draft guidance will help food establishments determine whether
the activities they perform are within the "farm"
definition established in regulations for the registration of food
facilities. Determining whether activities are within the
"farm" definition plays a key role in determining whether
a business is exempt from regulations for the registration of food
facilities and from certain CGMP requirements and requirements for
hazard analysis and risk-based preventive controls for human and
animal food. The guidance includes several hypothetical operations
as examples to assist businesses in evaluating their own
operations. Comments are due November 23, 2016, for the
two first draft guidance document, and February 21, 2017, for the
third draft guidance.
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