Watch out dictionary lovers and English majors, the U.S. Food and Drug Administration (FDA) is about to make your head spin. In its recent proposed rule for the Hazard Analysis and Risk-Based Preventive Control (HARPC) requirements under FSMA, FDA spent numerous pages defining “farm,” “harvesting,” “holding,” “manufacturing/processing,” and “packing” as they pertain to Food Facility Registration. These words may seem trivial, however, the definition changes will have far reaching effects for some in the food industry concerning which safety and sanitary controls will apply to various aspects of their operations.
A Food Facility is an establishment that manufactures/processes, packs, or holds food intended for the U.S. market. They must be registered with FDA. Farms are excluded from the registration requirement. Previously, the relevant concerns about whether an establishment was a farm revolved around the FDA’s Food Facility registration, and therefore its record-keeping regulations under the Bioterrorism Act (of 2002).
That all changed with the Food Safety Modernization Act (FSMA).
FSMA requires a Food Facility (not a farm) to comply with the HARPC food safety provisions whereas a farm is subject to new Standards for Produce Safety (if they grow/harvest covered crops). FDA’s recently proposed HARPC regulations specify that current Good Manufacturing Practices (cGMPs) for food do not apply to farms. Therefore, whether an establishment is a farm or not now really matters.
Complicating the question, however, FDA created a new category for the Food Facility Registration requirements: the “mixed-type facility.” A mixed-type facility is one which performs some activities which are exempt from registration (like farming) and some non-exempt activities requiring registration. A “farm mixed-type facility” will need to register with FDA and implement HARPC and food cGMPs for part of the establishment, while implementing Standards for Produce Safety for the other part (the farming part) of the establishment. So what does this mean moving forward?
- Establishments should reanalyze their operations to determine which safety and sanitary controls would apply if FDA finalized the changes as proposed.
- Some establishments will need to register even if they were previously exempted.
- Some companies (agriculture co-ops, fresh produce importers, farming operations that pack their own and other farms’ produce) should spend the time and get the help to distinguish their various operations and facilities as farms or manufacturers/processors/packers to avoid the mixed-type facility designation.
FDA is requesting comments to these proposed changes. The current deadline for comments is mid-May 2013.
