In the
seven years since the Food Safety Modernization Act became law, a serious
question of how closely the agency should work with producers, especially those
on the farm, has never been far below the surface. Food Safety News is
reporting this week that FDA recently gave itself “enforcement discretion” for
some of those complex FSMA rules involving farms. FDA Commissioner Scott
Gottlieb said it was all part of working “constructively with farmers and other
producers to achieve our shared goals around food safety.”
Peter
Lurie, president of the Center for Science in the Public Interest, was not
impressed. He says the new guidance for FSMA enforcement amounts to the Trump
Administration “undermining that landmark legislation.”
“FSMA
was intended to cover the entire food chain, from farm to fork, and the Trump
Administration’s new guidance would create a gap in that safety chain by
exempting, at least for now, some of those who harvest, package and hold food
produced on farms,” Lurie said in a statement from CSPI.
Since
the FSMA’s Produce Safety Rule first included a distinction between a “farm”
and a “facility,” the National Sustainable Agriculture Coalition praised FDA
for hitting the hold button. It says “this seemingly innocuous difference in
definition has sent farmers and packers spinning.” “One of the key sticking
points yet to be fully worked out by FDA is whether operations that are only
packing and holding intact, raw (unprocessed) produce will be subject to the
provisions of the Produce Safety Rule or the Preventive Controls Rule, ”
according to NSAC.
“How
farms and processing facilities are defined has a direct and significant impact
on which rules they are subject to, and by extension, these definitions affect
the potential costs or administrative burdens producers/processors may have to
undergo as part of compliance.”
FDA
attempted to ease confusion and tensions around the rulemaking by extending the
compliance dates for two types of operations. But they were still left subject
to the Preventative Controls Rule.
FDA’s
new guidance — released this past week — extends the enforcement delay for
farmers to include the Preventive Controls Rule. NSAC says the further
“enforcement discretion” policy will “ease stress on producers.”
“This
new policy will ensure that the types of operations described above will not
have the Preventive Controls requirements enforced against them at this time,”
NSAC says.
This
distinction between a “farm” and a “facility” is particularly important for
food hubs or nonprofit packing operations, that do not fit traditional
“majority ownership” definitions and have been as of yet unable to receive
clear answers from FDA as to which requirements apply to them.
Under
the new enforcement discretion policy, a nonprofit food hub that is aggregating
and distributing unprocessed produce may still need to register with FDA and
follow current good manufacturing practices but they do not have to adopt the
new Preventive Controls requirements until FDA finalizes a rulemaking
clarifying which rule governs their activities.
NSAC
says it supports “this process of clarification in an attempt to ease
regulatory burdens on family farmers and food hubs and that it looks forward to
working with FDA and with its members to achieve an outcome that honors FSMA’s
public health mandate to establish minimum requirements based in science and
risk analysis, which are also flexible enough to work for operations of all
types and sizes.
The
FSMA, with its preventive approach to food safety, for the first time gives FDA
authority to establish food safety requirements for farms producing fruits and
vegetables. There are some permanent exceptions written into the law.
A farm
that produces less than $25,000 in produce sales is exempt under the FSMA’s
Tester Amendment, named for Sen. Jon Tester, D-Montana. And the FSMA concerns
“covered produce,” meaning that is in its unprocessed state and usually
consumed raw.
Thus,
farms that grow only grains fall outside the FSMA’s jurisdiction because grain
isn’t considered produce. Still, the FSMA rules are complex, both individually
and in combinations with one another. Any determination of how the FSMA applies
to an individual produce grower is a task filled with complexities.
Well,
nobody thought the expansion of the FSMA’s areas of responsibility for quality
assurance would be a simple task, but the recent tolls from contaminated food
products were judged by the Congress to be too high and in need of stiffer
regulations. Clearly, FDA is on the pan to refine the system and quickly lead
to safer food. The needed improvements will not be simple, cheap or easy FSN
says—and, it is a process producers should watch closely if the credibility of
the food system is to be improved, Washington Insider believes.