Page 84 - Summer2015

Legislative Updates

FDA UNDERMINING THE TESTER-HAGAN AMENDMENT YET AGAIN
By Judith McGeary, Esq.

Past articles in Wise Traditions have dis- food establishments” in the Bioterrorism Act, but
cussed the federal Food Safety Modernization left the definitions of these entities to the FDA.
Act and the Tester-Hagan amendment at great The FDA’s definition of “farm” was in-
length. The focus has been on the high-profile credibly narrow, only covering producers who
aspects, particularly the extensive new regula- did absolutely no processing of any kind; even
tions that will be issued and the exemption for drying fruit or creating a salad mix was enough
small-scale, direct-marketing producers from to classify a farm as a facility and trigger the
many of these. registration requirement.
Another aspect of the Tester-Hagan amend- FDA’s definition of “retail food establish-
ment has received far less attention, but could ments” was broader, encompassing any estab-
also have very significant impacts on local food lishment whose primary function was to sell
producers. This issue dates back to 2002 and directly to consumers, determined by whether
the passage of the Bioterrorism Act. In that the business sold more than half of its products
statute, Congress directed the Food and Drug directly to individual consumers (not businesses).
Administration (FDA) to require every business However, since the Bioterrorism Act focused on
that holds, stores, processes, or manufactures registration of each location, the sales had to oc-
food—termed a “facility”—to register with the cur at the same location as the food processing
agency. in order to qualify. In other words, a business
Judith McGeary
is the Austin, Texas Between 2002 and 2010 (the passage of the that made jams in a commercial kitchen and sold
chapter leader, an Food Safety Modernization Act), few people paid them directly to consumers at the same location
attorney and much attention to the issue of facility registration. would be a retail food establishment; but if the
small farmer in The registration was free and more notable for its same business sold the same jams at a farmers
Austin, and the lack of enforcement than anything else. In fact, market, instead, it would not be a “retail food
executive director of many small businesses that were legally required establishment”—and would have to register with
the Farm and Ranch to register never even knew of the requirement. FDA.
Freedom Alliance. The Food Safety Modernization Act (FSMA) This issue had not gained much publicity
She has a B.S. in raised the issue of registration to a very different because of the lack of enforcement and because
biology from
Stanford University level. Under FSMA, facilities that have to register registration was not a great burden. With the
and a J.D. from the under the Bioterrorism Act also have to develop proposal of the new requirements in FSMA,
University of Texas extensive paperwork safety plans, called a Haz- however, it became a significant threat for direct
at Austin. She and ard Analysis and Risk-Based Preventive Controls marketing producers.
her husband plan (HARPC), conduct environmental testing, To address this problem, a section of the
run a small and more. If a business doesn’t have to register as Tester-Hagan amendment to FSMA modified
grass-based farm a facility, then these new requirements of FSMA the scope of the registration requirement. The
with sheep, cattle,
horses, and poultry. don’t come into play. amendment directed FDA to amend the definition
For more So who is a “facility”? The starting point is of retail food establishment to “clarify” that “the
information go to that anyone who holds, stores, manufactures, or sale of food products directly to consumers by
farmandranch- processes food is a facility, unless it is for per- such establishment and the sale of food directly
freedom.org or sonal consumption or otherwise specifically ex- to consumers by such retail food establishment
call (254) 697-2661. empted. Congress exempted “farms” and “retail include” sales at locations such as roadside stands
84 Wise Traditions SUMMER 2015 Wise Traditions

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