Tuesday, October 9, 2012

Registering Wineries as "Food Facilities"

Edit: The registration is now active.  Please register.

By Cary M. Greene

It’s time to try to register your winery with FDA.

As WineAmerica announced last July when the Food Safety Modernization Act became law, wineries are required to register as “food facilities” with the Food & Drug Administration (“FDA”) “[d]uring the period beginning on October 1 and ending on December 31 of each even-numbered year.”  See 21 U.S.C. § 350d(a)(3) (emphasis added).

That would mean wineries are supposed to renew their registration with FDA over the next three months.

Ordinarily, FDA’s website is user friendly and online registration fairly straightforward.  FDA even has a Help Desk line, 800-216-7331, in case you run into trouble.  Currently, however, the site where wineries would register contains a notice:

Biennial Registration Renewal for Food Facilities will not be available on October 1, 2012.  We therefore will not be accepting food facility registration renewals at this time.  Please check FDA’s website at http://www.access.fda.gov at a later date or sign up for FSMA updates to be informed when it becomes available.  Additional information regarding Registration Renewal may be found on the FSMA Registration page.

We’ve checked with FDA, and they’re saying that wineries don’t need to submit their renewal registrations for 2012 yet.  This doesn’t mean you’re released of your obligation to register this year, it just means you need to check periodically on FDA’s registration page, or the WineAmerica blog, until registration goes live.

Edit:  The registration is now active.  


  1. I found the following in this link and would show to exempt all wineries that sell more at the winery than what they distribute: http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081637.htm#IIId

    (Comment 76) Some commenters state that the definition of retail
    facility as ``a facility that sells food products directly to consumers
    only,'' should be revised to delete ``only.'' This is based on the
    following arguments: 148 Cong. Rec. H2858 specifies that retail food
    establishments include those facilities ``attendant'' to retail
    operations; because the proposed definition of retail food
    establishment included commissaries, distribution facilities for
    grocery stores, which are also attendant facilities, should be included
    as well; the legislative history makes several references to retail as
    ``sale to consumers as its primary function,'' warehouse clubs should
    be included in the definition of retail facility, based on this
    language at 148 Cong. Rec. H2726: ``[Retail] does not include a
    warehouse that does not provide articles of food directly to a retail
    consumer as its primary function * * *.''
    (Response) FDA agrees in part with these comments. Accordingly, we
    have revised the definition of retail food establishment to eliminate
    the restriction that such facilities must sell only to consumers to be
    considered a retail food establishment. This interim final rule defines
    ``retail food establishment'' as ``an establishment that sells food
    products directly to consumers as its primary function. A retail
    establishment may manufacture/process, pack, or hold food if the
    establishment's primary function is to sell from that establishment
    food that it manufactures/processes, packs, or holds directly to
    consumers. A retail food establishment's primary function is to sell
    food directly to consumers if the annual monetary value of sales of
    food products directly to consumers exceeds the annual monetary value
    of sales of food products to all other buyers. The term `` `consumers'
    does not include businesses. A `retail food establishment' includes
    grocery stores, convenience stores, and vending machine locations.''
    This change preserves the retail

    [[Page 58914]]

    exemption both for retail food establishments (such as grocery stores)
    that sell or transfer some products to sources other than a consumer
    (e.g., to other grocery stores), and for direct selling entrepreneurs,
    as long as their primary function is to sell directly to consumers.
    FDA further agrees that under the revised definition of retail food
    establishment, certain warehouse clubs may be exempt from registration,
    if, based on dollar volume of their sales, they sell food directly to
    consumers as their primary function.

    Keith Pritchard
    Slate Run Vineyard

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