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.
Edit: The registration is now active.
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
ReplyDelete(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
freethewineries.com
slaterunwine.com
online bussines
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