in accordance with a standard curriculum or is qualified by
training and experience). Written plans must include a writ-
ten Hazard Analysis that identifies and evaluates known or
reasonably foreseeable hazards for each type of food manu-
factured, processed, packed or held at the facility. Each plan
must also include preventive controls, including controls for
process, food allergens and sanitation, and a recall plan should
a hazard be discovered. In addition, facilities will be required
to develop monitoring procedures to document and verify
that the preventive controls are consistently performed and
implemented. For FDA to verify during inspection that these
buildings are sanitized appropriately. In addition, farmers
would have to ensure via periodic testing that all agricultural
water used on their crops is safe and of adequate sanitary qual-
“FSMA calls on FDA to increase inspections, particularly at ‘high-risk’
facilities prone to contamination...”
activities have occurred, facilities also will be required to provide the agency with copies of their food safety plans, including the Hazard Analysis, as well as records of the preventive
controls, monitoring, corrective actions and verification procedures.
While food producers would have some autonomy in
how they comply, they are still required to adhere to all the
provisions laid out in the proposed rule and, should they fail,
enforcement action may include mandatory recall of the contaminated product or regulatory correspondence requesting
swift corrective action.
The Produce Safety rule is based on Section 105 of FSMA,
which directs FDA to set science-based standards that, if effectively implemented, should minimize the risk of serious
adverse health consequences or death from contaminated produce. FDA defined “produce” in a somewhat peculiar way of
which farmers and producers must be aware. Specifically, FDA
deems “produce” to include fruits and vegetables grown for
human consumption, such as spinach, cantaloupe, tomatoes,
sprouts, mushrooms, strawberries and tree nuts, such as walnuts and almonds, just to name a few, but the rule also applies
to mixes of intact fruits and vegetables, such as fruit baskets.
Somewhat counterintuitively, however, “produce” does not
apply to a long list of raw agricultural commodities that are
rarely consumed raw, most notably potatoes, corn, squash,
Brussels sprouts, asparagus, artichokes, beets and eggplant.
Nor does “produce” include products produced for personal
or on-farm consumption or products destined for commercial
processing such as canning. The rationale for these exclusions
is that the food items would be expected to be cooked or
processed before consumption, thus reducing or eliminating
microorganisms of public health concern.
Under the Produce rule, farmers now face making costly
changes to how they conduct business. Potential changes may
include building fences to keep out wildlife, waiting a certain
period before harvesting crops where domestic animals have
grazed to ensure that the crops aren’t contaminated by animal
waste and ensuring and documenting that equipment and
sions of the rule, but the request is not automatically granted.
Rather, FDA will take into consideration whether granting the
modification is necessary in light of local growing conditions,
and whether the practices under the proposed modification
provide the same level of public health protection without
increasing the risk of adulteration.
Compliance & Cost Concern for Industry
The expected costs of complying with these new rules are a
major concern for industry. FDA has estimated that the overall first-year cost to industry for the Preventive Controls rule
will be $701 million, with an annualized cost of $472 million.
FDA estimates the annualized cost of the Produce rule at $460
million for domestic farms and $170 million for foreign farms,
for a grand total of $630 million annually. Many observers
believe FDA has underestimated the costs by a significant degree and that many operations may be forced out of business
by the costs and burdens imposed. Specific feedback from industry will be particularly important in helping shape the final
versions of these rules.
The expected costs to FDA and the impact on the budget
deficit are also major concerns. FSMA calls on FDA to increase inspections, particularly at “high-risk” facilities prone
to contamination, and to hire about 2,000 new inspectors, of
which the estimated cost for the government is $1.4 billion
over the first 5 years. FDA will most likely request congressional authorization for user fees from food companies and
farms to help pay for the increased oversight costs mandated
by FSMA, increasing the costs further for an industry already
facing looming compliance expenses associated with the new
rules. It is not inconceivable that many of these costs will be
passed on to consumers, driving the cost of food even higher
and making it harder for American families to adjust.
Next Steps in the Rulemaking Process
FDA expects to be challenged on many of the new mandates outlined in these proposed rules given the staggering
costs associated with implementation; therefore, it has sched-