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BY TONI TARVER
The Food Safety Modernization Act
and proposed rules compel food industry stakeholders
to be more proactive in ensuring food safety.
MODERNIZING
FOOD
SAFETY
from Farm to Fork
E
arlier this year, the U.S. Food and Drug
Administration (FDA) published two proposed
rules for the Food Safety Modernization Act
(FSMA) and held three public meetings for
information and oral commentary (at press
time, written comments due May 16, 2013). At
the public meeting in Chicago, Ill., Polly Costello of
Centennial, Wyo., described her familys encounter
with foodborne illness. Pollys mother, Ruby, had been
hospitalized for severe abdominal pain, dehydration,
and other fu-like symptoms after eating a salad made
with spinach contaminated with E. coli O157:H7; Ruby
died within fve days. Pollys husband, Ken, also had
experienced acute abdominal pain after eating the same
batch of contaminated spinach but recovered after a
week of extreme discomfort. The Costellos frmly
believe that foodborne pathogens can enter anywhere
along the [food] supply chain from [farm] feld to pack-
ing plant and that certain safeguards may have
prevented the misfortune they sufered. Their experi-
ence and concerns epitomize the main reasons for the
FSMA and the proposed rules addressing produce safety
and preventive controls for human food facilities: We
want people to eat more fresh fruits and vegetables; we
dont want them to be concerned about doing so, says
Michael Taylor, Deputy Commissioner, FDA Ofce of
Foods and Veterinary Medicine. Both proposed rules
emphasize the food industrys primary role in ensuring
safe food and preventing foodborne illness.
Produce Safety
The proposed rule on produce safety pertains to Title I
Improving Capacity to Prevent Food Safety Problems
of the FSMA and establishes science-based standards for
the growing, harvesting, packing, and holding of pro-
duce for human consumption. The produce safety rule
applies to most domestic and imported vegetables,
fruits, herbs, mushrooms, tree nuts, and sprouts in their
raw or natural state. The rule does not apply to agricul-
tural commodities that are rarely consumed raw, that
are subjected to a pathogen-killing step (e.g., a robust
thermal process), or that are grown for personal con-
sumption, nor does it apply to grains. The rule also
grants produce growers fexibility to use food safety
practices that are appropriate for the size and nature of
their agricultural operations. The [FSMA] has man-
dated that we allow for variances. This allows for
exemptions to all or part of the rule if certain criteria
are met, says Samir Assar, Director of Produce Safety
Staf, FDA Center for Food Safety and Applied
Nutrition (CFSAN). [Produce growers] would need to
show that practices under the variances provide the
same level of public health protection as the proposed
rule without increasing the risk of adulteration. Record
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keeping is required, but there is no requirement for a
written food safety plan.
Designed to minimize the risk of health conse-
quences or death, the produce safety rule identifes and
addresses the routes of microbial contamination of veg-
etables, fruits, and other produce. The principal
agricultural components causing microbial contamina-
tion of produce are agricultural water; biological soil
amendments of animal origin (e.g., composted manure);
employee health and hygiene; animals living in the area;
and equipment, tools, and buildings. The produce safety
rule requires the inspection of agricultural water sys-
tems under a farms control at the beginning of the
growing season, and the water must be safe for intended
use. Because biological soil amendments of animal ori-
gin may contain pathogens, the rule proposes measures
that address methods of application and time intervals
between application and harvesting. Workers at pro-
duce-growing operations are required to engage in
hygienic and health practices such as washing their
hands, maintaining personal cleanliness, and discontin-
uing their contact with produce when they are ill.
Produce-growing operations that keep domesticated
animals must make special eforts to keep animal feces
away from the produce; this is also true for wild animals
that may have access to crop felds. The produce safety
rules requirements to achieve this include instituting a
waiting period between animal grazing and harvesting
produce near or around the grazing area and monitoring
felds for the intrusion of wild animals immediately
before harvest and throughout the growing season. The
rule also sets standards for the inspection, sanitation,
and maintenance of equipment, tools, and buildings of
farming operations.
Produce growers that have annual sales of $25,000
or less do not have to comply with the produce safety
rule, and certain other farms engaged in direct farm
marketing are partially exempted from the rule.
Despite these exemptions, which account for more than
100,000 farms, the FDA estimates the produce safety
rule can prevent 1.75 million foodborne illnesses annu-
ally and save $1.04 billion in related costs for items such
as medical care and lost productivity at work.
Moreover, while some produce growers may be exempt
from the produce safety rule, no entity is exempt from
food safety. Taylor says that small growers are still
There are many aspects about the FSMA and the proposed
rules that not only break new ground but also cause
concern among food industry stakeholders.
MODERNIZING FOOD SAFETY
from Farm to Fork
Certain dark leafy greens (e.g., kale, collard and turnip greens) are typically
cooked before they are consumed, so they are exempt from the proposed
produce safety rule. Spinach and lettuces, which are commonly consumed
raw, are not exempt from the rule. iStockphoto/Thinkstock
pg
28 28 05.13 www.ift.org
accountable for complying with the rules and regula-
tions regarding the production and sale of safe food. The
compliance date for the produce safety rule is 60 days
after the fnal rule is published.
Preventive Controls for Human Food Facilities
The proposed rule for preventive controls for human
food facilities also pertains to Title I of the FSMA and
has two main components. First, the rule applies to
domestic and foreign facilities that manufacture, pro-
cess, pack, or hold human food and requires their
development and implementation of a written plan
addressing hazard analysis and risk-based preventive
controls. Second, the rule will revise the existing
requirements of Current Good Manufacturing Practices
(CGMPs). (Forthcoming proposed rules will address
foreign supplier verifcation, accreditation of third-
party auditors of foreign food facilities, and preventive
controls for animal food.)
For the written plan, every facility registered with
the FDA under the Food, Drug, and Cosmetic Act must
identify and evaluate known or reasonably foreseeable
unintentional hazards (i.e., a hazard analysis) for each
type of food it manufactures, processes, packs, or holds.
Such hazards could be biological, chemical, physical, or
radiological, and a reanalysis of hazards should occur at
least every three years. (The proposed rule for preven-
tive controls is not intended for hazards that may be the
result of deliberate adulteration. A separate rule will
deal with that issue.) Secondly, the written plan must
identify the preventive controls implemented to prevent
or minimize known or foreseeable hazards. The preven-
tive controls should include process controls, food
allergen controls, sanitation controls, and a recall plan.
Third, the written plan must identify monitoring prac-
tices to ensure that preventive controls are consistently
applied. Records that document monitoring activities
are also mandatory.
Next, the written plan must pinpoint corrective
actions that will occur when preventive controls are
improperly implemented. In addition to rectifying a
problem, corrective actions must also minimize the
prospect of recurrence, assess foods to determine
whether they are safe for consumption, and prevent
unsafe foods from entering the food supply. Verifcation
of the consistent implementation of preventive controls
is another requirement of the written plan. Not just
anyone can develop the written food safety plan. The
proposed rule requires that the written plan be pre-
pared by an individual who has successfully completed
special training or has job experience that qualifes him
or her for the task. In addition to developing the plan,
the qualifed individual will validate the preventive con-
trols, review records, and periodically reanalyze the
plan.
The second main feature of the proposed rule on
preventive controls is that the FDA will amend the
CGMPs for the manufacturing, packing, or holding of
human food. The CGMPs will be revised to make clear
that requirements for protection against contamination
of food includes protection against cross-contact
between food and allergenic ingredients such as eggs,
soy, or tree nuts. The revision will entail the updating of
some provisions and the deletion of others. The FDA is
also considering whether appropriate training for food
production employees should be required as well as
records of such training.
As with small farms and the produce safety rule,
certain facilities are exempt from the preventive con-
trols rule. Nevertheless, the revised CGMPs will be
applicable to all human food facilities even if they are
exempt from the requirements of conducting a hazard
analysis and establishing risk-based preventive controls.
Facilities that are exempt from hazard analysis and risk-
based preventive controls include small businesses that
engage in certain low-risk manufacturing, processing,
packing, or holding activities on farms for specifc
foods; facilities that produce low-acid canned food
(LACF) that is subject to the LACF regulation on
MODERNIZING FOOD SAFETY
from Farm to Fork
Standards for the health and hygiene of workers (e.g., hand washing) are emphasized in the
proposed rule on preventive controls for human food facilities. iStockphoto/Thinkstock
pg
30 30 05.13 www.ift.org
microbiological hazards; grain elevators and warehouses
that store raw agricultural commodities other than
fruits and vegetables; and facilities that manufacture,
process, or pack foods that are covered by the regula-
tions for Hazard Analysis and Critical Control Points
(HACCP) (i.e., juice and seafood).
Applicable to all segments of the food industry,
HACCP frst embodied the philosophy that the safety of
food requires the knowledge and understanding of haz-
ards that are likely to occur in a particular food or at a
food facility. Manufacturers, producers, and processors
should have such information and apply it to their busi-
nesses. There are seven guiding principles to HACCP;
the FDAs rule for preventive controls parallels most of
them: 1) conduct a hazard analysis, 2) determine the
critical control points (CCPs), 3) establish critical lim-
its, 4) establish a system to monitor control of CCPs, 5)
establish the corrective action to be taken when moni-
toring indicates that a CCP is not under control, 6)
establish procedures for verifcation to confrm that the
HACCP system is working efectively, and 7) establish
documentation concerning all procedures and records
appropriate to HACCP principles and their application.
The FDAs rule for preventive controls does not require
the setting of critical limits.
Because the rule for preventive controls for human
food facilities is still in its proposal stage, there are sev-
eral issues that the FDA has yet to determine and is
therefore seeking commentary from food industry
stakeholders. For example, the FDA is asking for input
on questions such as the following: Should the FDA
require personnel education and experience in the
CGMPs instead of merely recommending them? Should
the term very small business be defned as a business
with annual sales of less than $250,000, less than
$500,000, or less than $1 million? Should the FDA
include potential hazards that may be intentionally
introduced for economic reasons? Should a facilitys
review of complaintsincluding those from consum-
ers, customers, or other partiesbe required as a way
to verify that its preventive controls are efectively mini-
mizing the occurrence of hazards? Should the FDA
require fnished product testing? Should environmental
testing requirements be part of the fnal rule?
Comments to these and other issues for both proposed
rulespreventive controls and produce safetyare
due May 16, 2013 (at press time).
Concerns of Food Industry Stakeholders and Advocacy Groups
There are many aspects about the FSMA and the pro-
posed rules that not only break new ground but also
cause concern among food industry stakeholders. The
law changes every aspect of the food system from farm
to fork. For the frst time ever, comprehensive, science-
based preventive controls are mandatory across the food
supply, and the FDA can review records of preventive
controls and other components of food safety plans.
Also a frst, the FDA has the right to issue a mandatory
recall when a company fails to recall unsafe food.
Moreover, the FDA now has unprecedented authority to
require that imported foods meet U.S. food safety stan-
dards and to deny the import of any food from a foreign
facility or country that refuses to grant access to the
agency (80% of seafood, 50% of fruits, and 20% of veg-
etables consumed in the United States are imported).
And while some produce growers, processors,
manufacturers, and operators of warehousing facilities
think the proposed rules exemption categories are not
broad enough, consumer advocacy groups believe, when
it comes to food safety, there should be no exemptions
at all.
Vanessa Cofman, Education Manager of STOP
Foodborne Illness (www.stopfoodborneillness.org),
questions the logic of excusing an illness or a death by
claiming a food or facility was exempt from food safety
rules. Foodborne pathogens can reside anywhere, she
says; they do not distinguish between small and large
produce-growing operations or processing facilities.
Cofman also contends that exemptions for produce not
normally consumed raw are senseless as the potential
for contamination exists for these items as well. Cynthia
MODERNIZING FOOD SAFETY
from Farm to Fork
IFT Webcasts
Cover Proposed Rules
The Institute of Food Technologists has developed two on-
demand webcasts on the proposed rules. The webcast
Produce Safety Standards: FDA and Industry Expert
Insights provides detailed information about the proposed
rule for produce safety and potential implications for pro-
duce growers. Presenters are Samir Assar, Director of
Produce Safety Staff, FDA Center for Food Safety and
Applied Nutrition (CFSAN); James Gorny, Senior Advisor,
FDA CFSAN; and David Gombas, Senior Vice President, Food
Safety and Technology, United Fresh Produce Association.
The webcast Preventive Controls for Human Food: FDA
and Industry Expert Insights provides detailed information
about the proposed rule for preventive controls for human
food facilities and potential implications for manufacturers,
processors, and packagers of human food and warehousing
facilities. Presenters are Donald Kraemer, Senior Advisor,
FDA CFSAN; Virginia N. Scott, Senior Advisor, FDA CFSAN;
John Bode, Principal, John Bode LLC; and David Acheson,
Partner, Leavitt Partners LLC.
Both webcasts are available at http://www.ift.org/
knowledge-center/learn-online/on-demand-webcasts.aspx.
05.13 www.ift.org
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31
Haskins, Manager of Business Development &
Compliance at the Illinois Farm Bureau (www.ilfb.org),
also questions the rationale for allowing exemptions for
certain produce growers. She points out that some pro-
duce growers allow family pets to follow them around
the crop felds, which elevates the risk of contaminated
produce. Just because produce is grown on a smaller
scale does not guarantee it is safer, she says. Food
safety is everyones responsibility regardless of the farm
size. Haskins is alarmed by the Centers for Disease
Control and Preventions assertion that produce items
are the source for 46% of foodborne illnesses. That is a
shocking statistic and one that needs our attention, she
says.
Tom Knibbs, President of Urban Accents in
Chicago, Ill. (www.urbanaccents.com), says that his
small custom-blend spices company is committed to
food safety, but complying with the proposed rule on
preventive controls will be costly. For small and very
small companies, the preventive controls will be dif-
cult to implement in two years. A small or very small
company may not be as well-versed in food safety
requirements as a large company, he says. Compliance
with the FSMAs requirements for a written food safety
plan, periodic hazard analyses, record keeping, the hir-
ing or training of a qualifed individual, and
foreign-supplier and product certifcations must be
complete within one to three years of publishing of the
fnal rule on preventive controls, depending on the size
of the business. Large companies probably already have
food scientists and other staf members who can serve as
a qualifed individual and do what the FDA is requiring.
We all agree that food safety is important and take it
very seriously, but for small and very small companies,
these requirements are difcult to achieve. Four or fve
years to implement these requirements would be ideal,
he says. Realistically, you cant put a cost on safety, but
my concern is that we receive enough time and training
to meet the requirements.
Ernie Harben, Senior Manager, Safety and
Regulatory Compliance, of Saddle Creek Logistics of
Lakeland, Fla. (www.sclogistics.com), has diferent con-
cerns. From Harbens perspective, the requirements
and rules of the FSMA may place operational restric-
tions on facilities that hold food. The proposed rule on
preventive controls allows the exemption of
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MODERNIZING FOOD SAFETY
from Farm to Fork
warehousing facilities that engage solely in
holding packaged food that is not exposed to
the environment as long as the food does not
require refrigeration. We are concerned
about the FDAs interpretation of that rule,
specifcally whether the exemption applies to
facilities that [hold] packaged foods but may
also hold general retail consumer goods such
as electronics, paper products, and other non-
food items, Harben says. Financial costs are
another concern: Costs may be signifcant in
some areas such as the hiring of a qualifed
individual. We have facilities in 29 locations
[in 11 states] across the country, so we would
have to hire individuals across the country for
each facility. Costs for potentially hiring indi-
viduals to monitor temperature control and
perform quality analysis of food would also be
of concern, Harben explains. We pride our-
selves on our standards and ability to keep
food safe. However, we would defnitely have
to assess whats necessary for us in order to
continue to provide a high level of service to
all our customers. Peter Vardon, Senior
Economist, FDA CFSAN, says that the FDA
recognizes that fnancial costs are a signifcant
issue for some companies, so certain facilities
will have longer compliance periods than
others.
We like the fact that the proposed rule
[on produce safety] takes a risk-based
approach. We were concerned that there was
going to be a list of high-risk commodities
identifed in the rule, based on [past] out-
breaks and recalls, and were very pleased to see that is
not the approach the FDA took, says David Gombas,
Senior Vice President, Food Safety and Technology, of
United Fresh Produce Association in Washington, D.C.
(www.unitedfresh.org). However, the proposed rule for
preventive controls afects companies that grow and
minimally process fresh produce (i.e., mixed-type facil-
ities). He questions the need and fairness of requiring
mixed-type facilities to comply with both the produce
safety rule and the preventive controls rule. Roxanne
Junge, representing farmers markets in Glenview, Ill.,
has a similar complaint: She wonders whether produce
growers who wash, cut, or pack raw vegetables and
fruits may now have to register their facility and enact
other controls to comply with the preventive controls
rule. Donald Kraemer, Senior Advisor, FDA CFSAN,
says that the applicable proposed rule is contingent on
the treatment of the commodity as well as the commod-
ity itself. For example, if a farmer does nothing other
than grow and harvest produce, then his farm is subject
to only the produce safety rule. On the other hand, if a
facility engages in growing/harvesting one commodity
and processes another, then the produce safety rule
applies to the frst commodity and the preventive con-
trols rule applies to the latter commodity.
Change is difcult, and it is likely that many food
industry stakeholders fnd some aspect of the new food
safety law with which they disagree. However, foods
that cause illness or death thwart consumerism, which
is vital for the food industry. From the perspective of
the U.S. Congress and the FDA, there are two
approaches to food safety and foodborne illness: 1) help-
ing victims after adverse events occur and 2) preventing
adverse events from occurring. The implementation of
the FSMA indicates that U.S. lawmakers have embraced
the second approach, shifting U.S. policy on food safety
from reactive to preemptive. FT
Toni Tarver is Senior Writer/Editor for Food Technology magazine
(ttarver@ift.org).
The proposed rule on preventive controls for human food facilities establishes
analytical testing requirements for microbiological, chemical, physical, and
radiological contaminants. iStockphoto/Andreas Reh