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pdfDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Focused Mitigation Strategies to Protect Food
Against Intentional Adulteration
Docket No. FDA-2013-N-1425
Preliminary Regulatory Impact Analysis
Preliminary Regulatory Flexibility Analysis
Preliminary Unfunded Mandates Reform Act Analysis
Preliminary Paperwork Reduction Act Analysis
Economics Staff
Office of Regulatory Policy and Social Sciences
Center for Food Safety and Applied Nutrition
Contents
A. Introduction ................................................................................................................................ 3
B. Summary of Costs and Benefits ................................................................................................. 4
Table 1.—Annualized Cost and Benefit Overview ................................................ 5
C. Need for Regulation ................................................................................................................... 6
D. Costs and Benefits of the Proposed Rule: Detailed Analysis .................................................... 7
1. Costs of the Proposed Rule ............................................................................................. 9
a. Learning About the Proposed Rule and Creating a Food Defense Plan ........... 10
b. Actionable Process Steps and Focused Mitigation Strategies .......................... 11
Table 2.—Mitigation Strategies with Cost Estimates ........................................... 13
Table 3.—Costs of Mitigation .............................................................................. 16
c. Monitoring and Corrective Action .................................................................... 16
d. Training ............................................................................................................. 17
e. Annual Documentation and Plan Updating....................................................... 18
f. Costs to Foreign Firms ...................................................................................... 19
g. Total Costs ........................................................................................................ 19
Table 4.—Initial and Annualized Costs ................................................................ 20
2. Benefits of the Proposed Rule....................................................................................... 20
a. General Model................................................................................................... 21
b. Scenario 1 Attacks ............................................................................................ 22
c. Scenario 2 Attacks............................................................................................. 23
d. Scenario 3 Attacks ............................................................................................ 24
3. Analysis of Uncertainty ................................................................................................ 25
Table 5.—Low, Mean, and High Total Cost Estimates ........................................ 26
E. Analysis of Regulatory Alternatives ........................................................................................ 27
1. No Action ...................................................................................................................... 27
2. The Proposed Rule ........................................................................................................ 27
3. A Different Very Small Business Size than the Proposed Rule ................................... 28
Table 6.—Other Facility Exemptions ................................................................... 28
4. The Proposed Rule with Dairy Farm Requirements ..................................................... 28
Table 7.—Dairy Farm Rule Costs by Coverage ................................................... 30
5. Vulnerability Assessment Requirement ........................................................................ 31
6. Economically Motivated Adulteration Requirements .................................................. 32
Preliminary Regulatory Flexibility Analysis ................................................................................ 34
1. Number of Small Entities Affected............................................................................... 34
2. Costs to Small Entities .................................................................................................. 34
3. Regulatory Flexibility Options ..................................................................................... 35
4. Description of Recordkeeping and Recording Requirements. ..................................... 35
Unfunded Mandates ...................................................................................................................... 37
Small Business Regulatory Enforcement Fairness Act ................................................................ 38
Paperwork Reduction Act of 1995 ................................................................................................ 39
Table 8.—Estimated Annual Recordkeeping Burden ........................................... 44
References ..................................................................................................................................... 46
2
A. Introduction
The Food and Drug Administration (FDA or we) has examined the impacts of the proposed rule
under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and
13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other advantages; distributive impacts; and
equity). We believe that this proposed rule is a significant regulatory action under Executive Order
12866.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would
minimize any significant impact of a rule on small entities. The annualized costs per entity due to this
proposed rule are about $13,000 for a one-facility firm with 100 employees, and there are about 4,100
small businesses that would be affected by the proposed rule, so we tentatively conclude that the
proposed rule could have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a
written statement, which includes an assessment of anticipated costs and benefits, before proposing "any
rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year." The current threshold after adjustment for inflation is $141 million, using the
most current (2012) Implicit Price Deflator for the Gross Domestic Product. We expect this proposed
rule may result in a 1-year expenditure that would meet or exceed this amount.
3
B. Summary of Costs and Benefits
The proposed rule applies to human food facilities that are required to register and that are part
of businesses with more than $10 million in annual sales, with processing steps with significant
vulnerabilities and food at a high risk for intentional adulteration caused by acts of terrorism. Almost all
of these facilities are engaged in manufacturing or processing of foods, or are warehouses that handle
bulk liquid food. Restaurants, farms, animal food facilities, and distributors of raw agricultural
commodities are not covered by the rule. Most warehouses, packers, and labelers are not likely to pay
any costs as a result of this rule, because these types of facility are unlikely to have the processing steps
that create vulnerabilities. The covered facilities must create a food defense plan, identify actionable
process steps, implement focused mitigation strategies and related monitoring, corrective actions, and
verification activities to protect these steps, train designated employees in food defense, and document
these actions. We estimate the annualized costs of these measures to be about $370 million.
The benefits of the actions required by the proposed rule are a reduction in the possibility of
illness, death, and economic disruption resulting from intentional adulteration of food. We are unable to
quantify these benefits. However, in the Detailed Analysis, we monetize the damage that various
intentional adulteration scenarios might cause, and present a breakeven analysis showing the number of
prevented attacks at which the benefits are larger than the costs. For attacks that are similar in nature to
acts of intentional adulteration that have happened in the U.S. in the past, the breakeven is 18 to 37
attacks per year, depending on the portion of foreign firms’ costs that are passed through to U.S.
consumers. For attacks causing similar casualties as major historical outbreaks of food-related illness,
the breakeven prevention amount would be one or two attacks every year. For catastrophic terrorist
attacks causing thousands of fatalities, the breakeven is one attack prevented every 350 to 730 years.
4
Table 1.—Annualized Cost and Benefit Overview
All Numbers are USD 2010 (Millions),
Annualized over 10 years
Costs
Learning about Rule
Mitigation Costs
Monitoring and Corrective Action
Employee Training
Documentation
Subtotal (Domestic cost)
Cost to Foreign Firms
Total
Lower Chance of Intentional
Benefits Adulteration
3%
7%
Discount Discount
$
3
$
3
$ 59
$ 63
$ 100
$ 100
$
4
$
5
$
6
$
6
$ 172
$ 177
$ 185
$ 190
$ 357
$ 367
Unquantified
5
C. Need for Regulation
This regulation is mandated by statute. Sections 103 and 106 of the FDA Food Safety
Modernization Act of 2011 (FSMA) direct the Secretary of Health and Human Services to promulgate
regulations to protect against the intentional adulteration of food (Ref. (1)).
The people responsible for managing food production firms make many decisions about what
risks to invest in reducing. When doing so, they take into account the probability of the bad event, and
the damage the event would cause to their firm. If the probability multiplied by the damage is equal to or
greater than the cost of prevention, then they will invest in prevention.
For many bad events, all or most of the damage will be considered. For example, a small
adulteration incident that will likely be traced to the company may be expected to cause damage to the
company’s reputation and sales equal to or greater than the health damage that the contamination inflicts
on society. In this case, the managers will therefore invest the socially optimal amount (or more) in
preventing contamination.
However, the maximum damage that a major contamination event can cause to the owners of the
targeted company is the value of the company or the owners’ wealth. The social damage that a
catastrophic terrorist attack causes is therefore larger than the private damage done to people who could
have invested to stop it.
If an attack could cause more damage than the value of the company, then its probability
multiplied by the value of the company may be less than the cost of prevention, while its probability
multiplied by the total social damage is greater than the cost of prevention. In this case, it is not rational
for profit-maximizing managers to invest in prevention, but it is socially optimal. This rule is intended to
address these situations.
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D. Costs and Benefits of the Proposed Rule: Detailed Analysis
FDA is proposing to require domestic and foreign human food facilities to address hazards that
may be intentionally introduced by acts of terrorism. These food facilities would be required to identify
and implement focused mitigation strategies to significantly minimize or prevent significant
vulnerabilities identified at actionable process steps in a food operation. FDA is proposing these
requirements as part of our implementation of FSMA. We expect the proposed rule, if finalized as
proposed, would help to protect food from intentional adulteration caused by acts of terrorism.
The subject of the proposed rule is protection of food against intentional adulteration caused by
acts of terrorism. The proposed rule would apply to both domestic and foreign facilities that are required
to register under section 415 of the Federal Food, Drug, and Cosmetic Act. However, as explained in
the preamble, the proposed rule contains several exemptions:
The proposed rule would not apply to a qualified facility, except that qualified facilities
would be required to provide for official review, upon request, documentation that was
relied upon to demonstrate that the facility meets this exemption. As proposed, qualified
facilities include very small businesses, those that have less than $10,000,000 in total
annual sales of food, adjusted for inflation.
The proposed rule would not apply to the holding of food, except the holding of food in
liquid storage tanks.
The proposed rule would not apply to the packing, re-packing, labeling, or re-labeling of
food where the container that directly contacts the food remains intact.
The proposed rule would not apply to activities of a facility that are subject to section 419
of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
The proposed rule would not apply with respect to alcoholic beverages at a facility that
meets certain conditions.
The proposed rule would not apply to the manufacturing, processing, packing or holding
of food for animals other than man.
The proposed rule would establish various food defense measures that an owner, operator, or
agent in charge of a facility would be required to implement to protect against the intentional
adulteration of food. Specifically:
7
Prepare and implement a written food defense plan that includes actionable process steps,
focused mitigation strategies, and procedures for monitoring, corrective actions, and
verification.
Identify any actionable process steps, using one of two procedures discussed in the
preamble. FDA has determined that the presence of one or more of these key activity
types at a process step (e.g., manufacturing, processing, packing, or holding of food)
indicates a significant vulnerability under section 418 of the FD&C Act and that the food
is at high risk of intentional adulteration caused by acts of terrorism under section 420 of
the FD&C Act. These key activity types are: Bulk liquid receiving and loading; Liquid
storage and handling; Secondary ingredient handling; and Mixing and similar activities.
Facilities may identify actionable process steps using the FDA-identified key activity
types, or conduct their own facility-specific vulnerability assessments.
Identify and implement focused mitigation strategies at each actionable process step to
provide assurances that the significant vulnerability at each step will be significantly
minimized or prevented and the food manufactured, processed, packed, or held by such
facility will not be adulterated.
Establish and implement procedures, including the frequency with which they are to be
performed, for monitoring the focused mitigation strategies.
Establish and implement corrective action procedures that must be taken if focused
mitigation strategies are not properly implemented.
Verify that monitoring is being conducted and appropriate decisions about corrective
actions are being made; verify that the focused mitigation strategies are consistently
implemented and are effectively and significantly minimizing or preventing the
significant vulnerabilities; and conduct a reanalysis of the food defense plan.
Ensure that personnel and supervisors assigned to actionable process steps receive
appropriate training in food defense awareness and their respective responsibilities in
implementing focused mitigation strategies.
Establish and maintain certain records, including the written food defense plan; written
identification of actionable process steps and the assessment leading to that identification;
written focused mitigation strategies; written procedures for monitoring, corrective
actions, and verification; and documentation related to training of personnel.
8
If companies believe that the FDA-identified key activities type method to identify actionable
process steps in the proposed rule is not appropriate to their facilities, they have the option of conducting
their own vulnerability assessment. They may do so if they calculate that the costs of conducting their
own assessment are lower than the costs of the FDA-identified key activities type method, or if they
have already conducted an appropriate vulnerability assessment. To the extent that companies do this,
the costs of the proposed rule will be lower than the costs we estimate. We do not know how many firms
will choose these different measures, but we believe that the number will be low.
There is a large degree of uncertainty inherent in this analysis. To reflect this uncertainty, we
define many inputs as probability distributions. In this section, we illustrate the analysis with the mean
value of each probability distribution, rounding in the text for ease of reading but using the unrounded
point estimate in the example calculation to avoid introducing rounding errors. In the Analysis of
Uncertainty, we generate low and high estimates for the total costs with a Monte Carlo simulation that
draws values at random from the probability distributions.
For some parameters, we have a low and high estimate. In these cases, we draw the parameter
from a uniform distribution. The low estimate is the minimum value of the distribution and the high
estimate is the maximum value of the distribution. For other parameters, we have a low estimate, a high
estimate, and a best estimate. In this case, we draw the parameter from a triangular distribution. The low
estimate is the minimum value of the distribution, the best estimate is the peak of the distribution, and
the high estimate is the maximum value of the distribution. The mean of a triangular distribution is the
average of the three estimates used to generate the distribution.
When explaining the calculations, we show example calculations with the 7 percent discount
rate. Both 7 percent and 3 percent discount rates are reported in the summary tables.
1. Costs of the Proposed Rule
The proposed rule generates several new requirements for food facilities required to register. We
calculate these separately. In some cases, the actions that the proposed rule requires are already being
done (Ref. (2)). For facilities that are already following FDA guidances on food defense, the proposed
rule will not impose significant costs, but it will also not generate additional benefits.
We estimated the number of firms, facilities, and employees that the proposed rule would apply
to by using facility-level data from Dun & Bradstreet’s Global Business Database (Ref. (3)). The
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database included 99,800 facilities, and we searched by SIC codes to find facilities that the rule would
apply to. We included all human food manufacturers, including bottled water, nonalcoholic beverage,
dietary supplement, and food additive manufacturers. We excluded farms and retail because they are not
required to register, and warehouses because they are unlikely to have actionable process steps. Some
warehouses, such as those storing bulk liquid, may be affected by the proposed rule, and some
manufacturers, such as packers and labelers, may not be affected by the proposed rule because they have
no actionable process steps. However, we believe that both of these numbers are small. We seek
comment on this assumption. We assign all facilities to their parent company, and include all facilities of
companies that have more than $10 million in annual sales in the list of facilities that the proposed rule
would apply to.
We found 14,260 food production facilities that are part of firms with more than $10 million in
annual sales and are estimated to have actionable process steps. The total costs of identifying key
activity types, implementing mitigation strategies, monitoring, corrective actions, and verification are
based on this number of facilities. We found 47,416 firms with less than $10 million in annual sales and
4,624 firms with more than $10 million in sales. The total costs of learning about the proposed rule, and
documenting compliance, are based on these firm numbers. We found about 1.4 million employees in
firms that the proposed rule would apply to. The total costs of training are based on this employee
number.
The facilities that are part of firms with more than $10 million in sales produce 97 percent of the
total sales volume of food produced by registered facilities that are estimated to have actionable process
steps, and the qualified facilities produce 3 percent. The proposed rule therefore covers 97 percent of the
food market that is vulnerable to terrorist attack that could cause massive casualties; 3 percent of the
money that consumers spend on this type of food is spent on food that is not covered by the proposed
regulation.
a. Learning About the Proposed Rule and Creating a Food Defense Plan
The 4,600 firms that are covered by the proposed rule will spend time to learn about the
proposed rule and how to properly implement it, and to create a food defense plan according to the
proposed rule’s requirements. We estimate that this will take one individual at the level of an operations
manager, and also a legal analyst, between ten and thirty hours, or an average of twenty hours each per
business. We request comments on this estimation. For comparison, we estimated that the Preventative
10
Controls for Human Food proposed rule (Ref. (4)) will take the operations manager and legal analyst 40
hours each to learn about the proposed rule.
The mean hourly wage of an operations manager in the food manufacturing industry is $53.56
(Ref. (5)). We increase this cost by 50 percent to account for benefits and overhead, making the total
cost of time $80.34 ($53.56*1.5 = $80.34). The cost of the operations manager’s time is about $1,600
per business ($80.34*20 = $1,606.80). The mean hourly wage of a lawyer in the food industry is $65.23
(Ref. (5)), or $97.85 including benefits and overhead ($65.23*1.5 = $97.85). The cost of the lawyer’s
time is about $2000 per business ($97.85*20 = $1,956.90). The total initial cost per business is about
$3,600 ($1,606.80 + $1,956.90 = $3,563.70).
We annualize this cost over ten years at a 7 percent discount rate and calculate average
annualized costs of about $510 per business. Because there are about 4,600 firms covered by the
proposed rule (Ref. (3)), the total annualized cost to covered firms for learning about the proposed rule
and creating food defense plans is about $2.3 million ($507.39*4624 = $2,346,175).
The 47,000 firms that are exempt from the proposed rule because they have less than $10 million
in annual sales will each incur a burden to learn enough about the proposed rule to verify that they are
exempt. This will not require learning about the entire proposed rule; it will only require learning the
exemption criteria and the documentation requirement for qualified facilities. We estimate that this will
take one individual at the level of an operations manager between zero and four hours, or an average of
two hours, per business. We request comments on this estimation.
At a time cost of $80.34 per hour for the operations manager, the learning cost per exempt
business is then about $160 ($80.34*2 = $160.68). We annualize this cost over ten years at a 7 percent
discount rate and calculate annualized costs of about $23 per exempt business. Because there are about
47,000 exempt firms (Ref. (3)), the total annualized costs to these firms for learning about the proposed
rule will be about $1.1 million ($22.88*47,416 = $1,084,746).
b. Actionable Process Steps and Focused Mitigation Strategies
11
For each of the 14,260 food production facilities covered by the proposed rule and estimated to
have actionable process steps, we estimate that an individual at the level of an operations manager will
have to spend five to ten hours, or an average of 7.5 hours, identifying the actionable process steps in
that facility.1 We request comments on this estimation. At a time cost of $80.34 per hour for the
operations manager, the cost of identifying actionable process steps is then about $600 per facility
($80.34*7.5 = $602.55).
The proposed rule requires firms to identify and implement focused mitigation strategies at each
actionable process step to provide assurances that the significant vulnerability at each step will be
significantly minimized or prevented and the food manufactured, processed, packed, or held by such
facility will not be adulterated. The proposed rule does not specify a specific number or set of focused
mitigation strategies to be implemented. For the purposes of cost estimation, we considered the
implementation of the following focused mitigation strategies:2
1. Establish check-in and shipment verification procedures, such as seals and associated
documentation.
2. Restrict movement of delivery drivers once they are in the facility.
3. Secure transfer hoses in locked cabinets.
4. Establish key check-in/check-out procedures.
5. Install locks on tanks.
6. Physically inspect cleaned equipment.
7. Prohibit staff from bringing personal items into manufacturing areas.
8. Ensure clear line of sight to actionable process steps (e.g., store stacks of pallets in less
obstructive location).
9. Reduce staging time of ingredients.
10. Retrofit equipment to reduce accessibility (e.g., install lids on open mixers).
1
This estimate is for large firms and comes from internal experts who have conducted these kinds of vulnerability
studies at many facilities. Once managers learn about vulnerabilities, they can conduct an assessment on their own.
2
The list was generated with input from internal technical experts who have extensive experience conducting
vulnerability assessments and identifying focused mitigation strategies. While focused mitigation strategies are facilityspecific and are tailored to address vulnerabilities associated with a facility’s processing environment, we believe the list is a
reasonable approximation of what facilities might do and serves as a representative sampling of focused mitigation strategies
facilities might employ. The examples provide a range of capital investment and operational changes to illustrate the diversity
of potential focused mitigation strategies.
12
We are not proposing to require a specific set of focused mitigation strategies to be applied.
Rather, we expect facilities to identify and implement those focused mitigation strategies that are
necessary and relevant for each actionable process step in their operation. The focused mitigation
strategies used to estimate costs serve as examples of focused mitigation strategies that a facility may
identify as suitable for their operation. We expect that the focused mitigation strategies a facility
employs would be sufficient to significantly minimize or prevent significant vulnerabilities identified at
actionable process steps, but under our proposal the determination of specifically what focused
mitigation strategies to implement would rest with the facility.
Some of the covered facilities are already implementing these mitigation strategies (Ref. (2)).
We do not have data on the current adoption rates and costs of these particular mitigation strategies, but
we do have data on the adoption rates and costs of many similar strategies. Where we have data on a
similar strategy, we use it, and we estimate costs where we do not have data.
RTI International and the Institute of Food Technologists supplied FDA with data on food
defense practices from industry interviews and a literature review (Ref. (6)). The following table shows
the practices for which they provided cost estimates, and the strategy or strategies on our list that are
equivalent or accomplish the same function:
Table 2.—Mitigation Strategies with Cost Estimates
Strategy with RTI Cost Estimate:
Prohibit after hours key drop deliveries of raw materials
Electronic access controls for employees
Secured storage of finished products
Secured storage of raw materials
Cameras with video recording in storage rooms
Peer monitoring of access to exposed product
Equivalent to:3
1,2
4,2
3,5,10
3,5,10
8
8
This leaves strategies 6, 7, and 9 without estimates of cost or adoption rates.
3
By “equivalent,” we mean that these strategies serve the same function and provide an equivalent risk reduction.
To the extent that a cheaper strategy can be used, the costs of the rule will be lower than these estimates.
13
RTI used their data to create a prototype food defense cost model. We use this model to estimate
the average cost per facility of implementing all of the focused mitigation strategies in the table above
for facilities with 100 or more employees that did not currently employ them. When calculating the costs
of each strategy, zero costs are assigned to facilities currently implementing that strategy. The average
adoption rate for these strategies is 70 percent. The model does not take into account potential cost
savings from implementing multiple strategies simultaneously. To the extent that cost savings can be
realized by doing this, the costs of the proposed rule will be lower than our estimate. It is also likely that
companies will not need to implement all of the strategies we considered here for cost estimation
purposes. To the extent that they need to implement fewer strategies, the costs of the proposed rule will
be lower than our estimate.
The costs of these focused mitigation strategies are a mix of initial capital costs and annual
personnel costs. The costs of prohibiting after-hours key drop deliveries are the labor hours that would
likely be necessary to supervise all raw materials deliveries during the plant’s operating hours. The costs
for electronic access control systems include the initial costs of installing readers on doors in the facility
and setting up the initial cards for each employee in the plant, and annual costs for additional cards
(purchase costs and labor costs to program the cards for each employee). The costs of secured storage of
finished products and raw materials are the costs of installing electronic access controls on the doors to
the rooms with those products. The costs of surveillance cameras with video recording in storage rooms
are primarily the costs of purchasing and installing the cameras. The costs of peer monitoring are the
costs of annual training and posting signs with reminders and numbers to call.
In addition to these direct costs, and the costs of monitoring and corrective action quantified in
the next section, there may be indirect costs related to lost productivity or other side effects from
implementing these mitigation strategies. We were unable to quantify these costs, and request comments
and data that would help us estimate them in the final Regulatory Impact Analysis.
Because these initial costs involve the purchase of capital equipment (Ref. (6)), they are
annualized over the expected seven-year life of the equipment. The equipment will have to be replaced
periodically, in contrast to the other initial costs that only occur once and are therefore annualized over
the full ten years of the analysis.
The low estimate of the initial capital cost of these focused mitigation strategies is $3,993, the
best estimate is $9,039, and the high estimate is $16,616, for an average of about $10,000 per facility
14
([$3,993+$9,039+$16,616]/3 = $9,882). The low estimate of the recurring costs of the strategies is $583,
the best estimate is $1,609, and the high estimate is $4,631, for an average of about $2,300 per facility
([$583+$1,609+$4,631]/3 = $2,274). For costs of each individual strategy, see Table 3.
We estimate that physical inspection of cleaned equipment (Strategy 6) will require first-line
supervisors and other people responsible for quality control to spend about six minutes per inspection,
and that there will be 100 to 300 inspections per year, resulting in a time cost of between 10 and 30
hours per year, per facility, or an average of 20 hours. We estimate that about 70 percent of facilities
already employ this mitigation strategy, so this cost will be borne by 30 percent of facilities. We request
comments on these estimations. The mean hourly wage of a first-line supervisor of production and
operating workers in the food industry is $23.32 (Ref. (5)), or $34.98 including benefits and overhead
($23.32*1.5 = $34.98). This means that their time costs will be about $700 per year per facility newly
implementing the strategy ($34.98*20=$699.60). The average annual cost per covered facility is then
about $210 ($699.60 * 30% = $209.88).
We estimate that establishing procedures to prohibit staff from bringing personal items into
manufacturing areas (Strategy 7) will require one individual at the level of an operations manager, and
also a legal analyst, between one and three hours, or an average of two hours each, per facility. At a time
cost of $80.34 per hour for the operations manager and $97.85 for the lawyer, the total one-time cost per
facility is then about $360 (2*$80.34 + 2*$97.85 = $356.37). The costs of enforcing these procedures
are included in the ‘Monitoring and Corrective Action’ section below.
Facilities may need to provide secure areas to store personal items that cannot be brought to the
manufacturing area. However, many facilities already provide employee lockers, break rooms, or other
areas where personal items can be kept away from processing areas because it is common practice to
restrict personal items from processing areas due to food safety (unintentional adulteration) and
sanitation reasons. Alternatively, facilities could require employees to leave most personal items at
home or in employees’ cars. We assume that there will be no additional costs from these procedures.
We are unable to estimate the cost of reducing the staging time of ingredients (Strategy 9)
because decisions about the flow of raw materials through a production plant can have a wide variety of
effects on productivity, personnel costs, and production planning. We request comments on estimating
the cost of this focused mitigation strategy.
15
For the purposes of this cost estimate, we assume that Strategy 9 will not be employed because it
would impose a large burden and other focused mitigation strategies are sufficient to control the
significant vulnerability. We assume that it is necessary to employ all of the other strategies. To the
extent that fewer focused mitigation strategies are necessary to protect the actionable process steps, the
costs of the proposed rule will be lower than our estimates.
The total initial cost of identifying key activity types and implementing mitigation strategies is
about $11,000 per covered facility ($602.55 + $9,882 + $356.37 = $10,841.29). The annualized cost of
these initial costs is about $1,900 per facility. The annualized recurring costs are about $2,500 per
facility ($2,274 + $210 = $2,484). The total annualized cost is about $4,400 per facility ($1,926 +
$2,484 = $4,410).
Table 3.—Costs of Mitigation
Average cost per covered facility
Initial
Identity key activity types
Prohibit after hours key drop deliveries of raw materials
Electronic access controls for employees
Secured storage of finished products
Secured storage of raw materials
Cameras with video recording in storage rooms
Peer monitoring of access to exposed product
Physical inspection of cleaned equipment
Prohibit staff from bringing personal items
Total
$ 603
$
$ 1,122
$ 1,999
$ 3,571
$ 3,144
$
47
$
$ 356
$10,841
Recurring
$
$ 1,070
$
82
$
$
$
$ 1,122
$ 210
$
$ 2,484
Total
Annualized
$ 107
$ 1,070
$ 281
$ 355
$ 634
$ 559
$ 1,131
$ 210
$
63
$ 4,411
Because there are about 14,300 facilities that are part of firms that must implement focused
mitigation strategies (Ref. (3)), the total annualized costs of focused mitigation strategies in these
facilities will be about $63 million ($4,410*14,260= $62,886,600).
c. Monitoring and Corrective Action
The rule requires that facilities establish and implement procedures for monitoring the focused
mitigation strategies, and for taking corrective action if focused mitigation strategies are not properly
implemented.
16
It also requires that facilities verify that monitoring is being conducted, appropriate decisions
about corrective actions are being made; and that the focused mitigation strategies are consistently
implemented and are effectively and significantly minimizing or preventing the significant
vulnerabilities.
Given that the focused mitigation strategies can include relatively frequent activities that
employees may wish to bypass, such as keeping equipment and transfer hoses locked when not in use,
controlling keys and employee access, and ensuring that employees do not bring personal items into the
manufacturing area, we estimate that monitoring and documenting the focused mitigation strategies, and
implementing corrective action as needed, will require first-line supervisors and other people
responsible for quality control to spend between 100 and 300 hours per year, per facility.4 We request
comments on this estimate.
Given the time cost of $34.98 for first-line supervisors, the costs for monitoring and corrective
action will be about $7,000 per year per facility ($34.98*200=$6,996).
Because there are about 14,300 facilities that are part of firms that must implement mitigation
strategies (Ref. (3)), the total annual costs of monitoring, corrective action, and verification in these
facilities will be about $100 million ($6,996*14,260 = $99,762,960).
d. Training
All supervisors and employees assigned to actionable process steps in covered facilities must
receive appropriate training in food defense awareness, and this training must be documented. We
estimate that the training and documentation will require between zero and two hours, or an average of
one hour, per employee when the proposed rule takes effect or when a new employee is hired. We also
estimate that between 10 percent and 50 percent, or an average of 30 percent, of all workers and
supervisors in covered facilities are assigned to work at actionable process steps. We request comments
on these estimations.
4
This estimate comes from internal food defense experts. This is an estimate for the larger facilities likely to be
covered by the rule. Small facilities would take less time, but most of them will be exempt.
17
The mean hourly wage in the food manufacturing industry is $16.13 (Ref. (5)), or $24.20
including benefits and overhead ($16.13*1.5 = $24.20). This average includes both production workers
and supervisors. With one hour of training per worker, the initial training cost is $24.20 per worker
receiving training. We annualize this cost over ten years at a 7 percent discount rate and calculate
average annualized costs of about $3.40 per employee receiving training. Employee turnover in the food
manufacturing industry is high, so we estimate that turnover is about 33 percent for the covered
facilities. We request comments on this estimation. With a turnover of 33 percent, annual training costs
per job will be about $8 per position requiring training ($24.20*0.33=$7.98). Adding the annual training
costs to the annualized initial costs yields annual training costs of about $11.43 per job at an actionable
process step ($3.44+ $7.98 = $11.43).
Some training required by the proposed rule would be generic and some would be specialized.
We are proposing that certain personnel be trained in: (1) food defense awareness and (2) their
respective responsibilities in implementing focused mitigation strategies. FDA has published training
courses, which are available online and can be used to meet the proposed requirement for food defense
awareness training. Training employees in their specific responsibilities in implementing focused
mitigation strategies (relevant to the actionable process step to which the employee is assigned) is
included in the cost estimates for those strategies. The development of focused mitigation strategies and
their required implementation is included in the cost of learning about the rule and creating a food
defense plan.
There are about 1.4 million employees in firms covered by the proposed rule (Ref. (3)), so the
total annualized costs of the training required by the proposed rule will be about $4.8 million
($11.43*1,386,156*30% = $4,752,785).
e. Annual Documentation and Plan Updating
The 4,600 businesses covered by the proposed rule will also face annual costs to document
compliance with the food defense plan and update it as appropriate. These costs are in addition to the
per-employee costs of documenting that employee’s training, calculated in the previous section. We
estimate that the overall documentation will take one individual at the level of an operations manager,
and also a legal analyst between zero and ten hours, or an average of five hours each per business. We
request comments on these estimations.
18
At a time cost of $80.34 per hour for the operations manager and $97.83 per hour for the lawyer,
the recurring annual costs are about $890 per business ($80.34*5 + $97.85*5 = $890.93). Because there
are about 4,600 firms covered by the proposed rule (Ref. (3)), the total annualized documentation costs
to these firms will be about $6.5 million ($890.93*4,624 = $4,119,637).
Businesses that are exempt from the proposed rule because they are qualified facilities must be
prepared to give to FDA inspectors the documentation that was relied upon to demonstrate that the
facility meets the exemption. We estimate that this preparation and updating of files will take one
individual at the level of an operations manager between zero and one hour, with a mean estimate of 30
minutes, each year. We request comments on this estimation.
At a time cost of $80.34 per hour, the annual costs of documentation are about $40 ($80.34*.5 =
$40.17). Because there are about 47,000 firms that are exempt because they are qualified facilities (Ref.
(3)), the total annualized costs to these firms for documenting their exemption will be about $1.9 million
($40.17*47,416 = $1,904,701).
f. Costs to Foreign Firms
There are about 109,000 foreign facilities registered to import food into the U.S. (Ref. (7)). Some
of these facilities will also face costs as a result of the rule. We assume that the distribution of foreign
facilities is similar to that of domestic facilities in ownership structure, size, and type. In that case, the
proportion of domestic and foreign facilities that the proposed rule would apply to is the same. The
proposed rule would apply to about 14,300 of 99,800 domestic facilities, so we estimate that it would
apply to about 15,600 foreign facilities (14,260/99,800*109,000 = 15,575).
The average annualized cost of the rule for domestic facilities that the rule applies to is about
$12,200. Foreign facilities are likely to have lower labor costs, but also lower adoption rates, so our best
estimate of the average cost per foreign facility is the average cost per domestic facility. The total
estimated annualized cost to foreign firms is then about $190 million ($12,193*15,575= $189,905,975).
The costs are $185 million when annualized at 3%, and the initial costs are $354 million.
g. Total Costs
The total cost of the proposed rule, annualized over 10 years at a 7 percent discount rate, is about
$367 million. With a 3 percent discount rate, the annualized cost is about $357 million. The first-year
19
cost is about $687 million. Counting only domestic firms, the total annualized costs are $177 million at a
7% discount rate and $172 million at a 3% discount rate, with initial costs of $333 million. The average
annualized cost of the rule for domestic firms that the rule applies to is about $38,000.
The following table shows, for each component of the proposed rule, the total first-year cost and
the annualized cost at 3 percent and 7 percent discount rates. It also shows the average costs per exempt
and covered firms. Totals are in millions of dollars, and averages are in dollars:
Table 4.—Initial and Annualized Costs
Cost ($Millions)
Initial
Learning: Exempt Firms
Documentation: Exempt Firms
Exempt Domestic Firm Subtotal
Exempt Firm Average ($)
Learning: Covered Firms
Mitigation: Initial Costs
Mitigation: Annual Costs
Monitoring and Corrective Action
Initial Training
New Employee Training
Documentation: Covered Firms
Covered Domestic Firm Subtotal
Covered Domestic Firm Average ($)
Subtotal (Domestic cost)
Cost to Foreign Firms
Total
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
7.6
1.9
9.5
200
16.5
154.6
35.4
99.8
10.1
3.3
4.1
323.8
70,000
333.3
353.6
686.9
Annualized Annualized
3%
7%
$
0.9
$
1.1
$
1.9
$
1.9
$
2.8
$
3.0
$
59
$
63
$
1.9
$
2.3
$
23.6
$
27.5
$ 35.4
$ 35.4
$ 99.8
$ 99.8
$
1.2
$
1.4
$
3.3
$
3.3
$
4.1
$
4.1
$ 169.3
$ 173.9
$ 36,600
$ 37,600
$ 172.1
$ 176.9
$ 185.0
$ 189.9
$ 357.1
$ 366.8
2. Benefits of the Proposed Rule
This proposed rule is focused on reducing the potential for intentional adulteration of food at an
actionable process step, i.e., a point, step, or procedure in a food process at which food defense measures
can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such
vulnerability to an acceptable level. This reduction can be from detecting the perpetrators as they
attempt the act, or from deterring an attack because the food supply is known to be harder to
contaminate. Deterring an attack may cause perpetrators to choose an alternate target (Ref. (8)), so the
benefit of the proposed rule is based on the difference in damage between the attack on a large food
20
production facility that is prevented and the alternate attack on some other target that is conducted
instead.
a. General Model
The expected annual benefits of preventing intentional adulteration of food are
1) the annual likelihood of an attempted attack that will succeed without the proposed rule,
multiplied by
2) the likelihood that the otherwise successful attack will be prevented as a result of the proposed
rule, multiplied by
3) the expected damage that the attack would do if it was successful, minus the damage, if any,
of an alternate attack that happens as a result of the perpetrator choosing a different target.
A successful attack is one that is not detected until after the adulterated food has harmed
consumers. Although the proposed rule is intended to reduce the possibility of a terrorist successfully
using the food supply to harm large numbers of people, the potential benefits of the proposed rule come
from preventing various attack scenarios. Solely for the purpose of this analysis, we define three attack
scenarios and estimate the harm caused in each scenario.
Scenario 1 attacks are those that resemble previous acts of intentional adulteration in the United
States. There have been several documented cases (Ref. (9)) of intentional adulteration of food for
reasons other than profit in the United States, although these attacks were acts of disgruntled employees
rather than acts of terrorism. All of these incidents occurred at the retail level, and none of them resulted
in fatalities or widespread illness.5
5
While there have been many acts of intentional adulteration outside of the U.S. that have resulted in fatalities, in all
cases that we are aware of, the point of contamination has occurred close to the point of consumption. These events have
occurred in a post-manufacturing environment, which is outside the scope of this proposed rule. Specifically, there are many
reported examples of fatalities occurring due to post-manufacturing adulteration of food in China where restaurant owners or
operators intentionally adulterated competitors’ food.
21
Scenario 2 attacks are those that resemble past cases of major outbreaks of foodborne illness in
the United States. A successful introduction of a contaminant at an actionable process step would cause,
at minimum, a Scenario 2 attack.
Scenario 3 attacks are those that could be caused by skilled terrorists with advanced knowledge
of contaminants and the food supply, and the intention to kill as many people as possible. Such an attack
would cause tens or hundreds of thousands of illness cases, and potentially thousands of deaths. An
example of such a large-scale attack is modeled by Liu and Wein (Ref. (10)).
The benefits of the proposed rule are a reduction in the chances of these attacks being attempted
and the success of the attacks if attempted. We do not have enough information to calculate this
reduction in probability. We have very limited information on the expected number of attempted attacks
per year, and no numerical estimate of how this proposed rule will reduce the chances that each attack is
successful. This means that we are unable to quantify the benefits of the proposed rule.
Therefore, we present a breakeven analysis. We calculate the dollar value of the damage that the
average attack might cause, and subtract the damage multiplied by the probability of an alternate attack,
to find the expected monetized benefit if the proposed rule prevents an attack. We then compare that
number to the annual cost of the proposed rule. This yields the annual reduction in the odds of a
successful attack at which the benefits of the proposed rule outweigh the costs.
We conduct this analysis separately for each attack scenario, presenting the breakeven point for
the proposed rule assuming that it only prevented attacks of that type. It is possible that the proposed
rule may prevent attacks of all three types, but we do not have the information required to adjust the
breakeven points to reflect this.
b. Scenario 1 Attacks
There have been several documented attacks on the U.S. food supply (Ref. (9)), although none of
them occurred at an actionable process step in a covered facility. The recorded attacks on the food
supply in the U.S. have each resulted in several dozen to a hundred illnesses and no fatalities. Future
attacks that also did not occur at actionable process steps would likely cause harm of similar magnitude.
Although the proposed rule is not intended to cover such attacks, the food defense awareness training
required by the proposed rule might result in the prevention of these attacks in covered facilities.
22
Based on this data (Ref. (9)), we estimate that the average Scenario 1 attack would cause 50
cases of illness, and that each case would cost about $2,000 (Ref. (4)), so that the average health damage
per attack is $100,000 ($2,000*50 = $100,000).
We believe that such an attack would cause a recall of the affected food. The average cost of a
small or medium recall is about $10 million, as described by research for the Grocery Manufacturers'
Association (Ref. (11)). If a Scenario 1 attack is prevented, then there would be no alternate attack,
because the attack would be either one of convenience or motivated by a desire to harm one specific
company. Therefore, the benefits per prevented Scenario 1 attack are about $10 million ($10+0.1 =
$10.1). Note that the casualty estimates are based on cases where there was a recall; in the absence of
detection and recall, casualties would likely have been higher and there may have been fatalities.
The annualized costs of the proposed rule to domestic firms are $177 million. If no foreign costs
were passed on to Americans, and if the actions undertaken as a result of this proposed rule only
prevented Scenario 1 attacks, they would have to prevent 18 or more Scenario 1 attacks per year for the
benefits to be larger than the costs ($177/$10.1 = 17.5). If all costs to foreign firms were passed on to
Americans, then the annualized costs would be $367 million and the rule would have to prevent 37 or
more Scenario 1 attacks per year for the benefits to be larger than the costs ($367/$10.1 = 36.3).
c. Scenario 2 Attacks
A Scenario 2 attack, the successful introduction of a contaminant at an actionable process step,
would likely produce casualties equivalent to a major outbreak of food-related illness due to
unintentional contamination at a production facility. We estimate that the average Scenario 2 attack
would result in about a thousand illnesses and ten fatalities, based on the history of major outbreaks
described in the FDA’s Risk Assessment for Food Terrorism (Ref. (12)). Note that this is a mean, not a
median; most major outbreaks cause around a hundred illnesses but public health estimates for some
outbreaks indicated more than 100,000 illnesses (Ref. (12)).
The monetized value of illness from such an attack is about $2 million ($2,000*1,000 =
$2,000,000). With a Value of a Statistical Life of $8.1 million, the monetized value of the deaths is $81
million ($8.1*10 = $81). Such an attack would also likely prompt a major recall of the affected food,
and major recalls are much more expensive than small or medium recalls, costing about $200 million
23
(Ref. (11)). The total cost of an attack is then $283 million. ($2+$81+$200 = $283). Again, the
casualties would likely be higher without the recall.
We do not know the probability of an alternate attack, so we model it as a uniform distribution
with minimum zero and maximum one, with an average estimate that 50 percent of Scenario 2 attacks
on the food supply prevented by this proposed rule will result in an alternate attack on some other target.
We do not know how much damage this alternate attack would cause, but we know that it is expected to
cause at least some damage, and slightly less damage than an attack on the food supply. If an alternate
attack was expected to cause more damage for the same amount of terrorist effort, it would have been
chosen as the target instead of the food supply. Therefore, we estimate the damage caused by the
alternate attack as a uniform distribution with minimum slightly more than zero and a maximum slightly
less than the expected damage of an attack on the food supply, with an average estimate of 50 percent of
the expected damage.
Therefore, the average expected benefits of preventing a Scenario 2 attack on the food supply are
$212 million ($283*(1-(0.5*0.5)) = $212.25).
If the actions undertaken as a result of this proposed rule only prevented Scenario 2 attacks, and
no foreign costs are passed on to Americans, they would have to prevent one attack every year for the
benefits of the proposed rule to outweigh the costs ($177/$212.25 = 0.6). If all foreign costs were passed
on, the rule would have to prevent two attacks per year for the benefits to be larger than the costs
($367/$212.25 = 1.73).
d. Scenario 3 Attacks
The hypothetical Scenario 3 attack modeled by Liu and Wein (Ref. (10)) resulted in about
100,000 illnesses and 5,000 fatalities. Other agents introduced at an actionable process step for a widely
distributed food might cause similar casualty figures. The advanced techniques that would cause a
Scenario 3 attack would likely generate average illness costs higher than the other two scenarios; we
estimate that each nonfatal case of illness would have a cost of about $50,000 (Refs. (4) and (10)). The
monetized value of the illnesses is about $5 billion ($50,000*100,000 = $5,000,000,000) and the
monetized value of the deaths is about $41 billion (8.1*5,000 = 40,500), for a total health damage of $46
billion ($5+$40.5 = $45.5). As with the Scenario 2 attack, there may be an alternative attack, so the
24
expected health benefit of preventing a large-scale attack is about $34 billion. (45.5*(1-(0.5*0.5)) =
34.3).
There are many expected economic damages from a catastrophic terrorist attack in addition to
the lives lost and illnesses caused. Catastrophic terrorist attacks cause reductions in investment and
consumer confidence, leading to reductions in GDP growth (Ref. (13)). The cumulative damages due to
these indirect effects of terrorism are estimated to be $190 billion, most of which comes from a
recession and a reduction in the growth rate of the economy (Ref. (13)). If the Scenario 3 attack is
prevented, these damages will be prevented, but if an alternate attack of comparable magnitude is
conducted, they will not be, so the expected benefit of preventing indirect damages is about $95 billion
($190*(1-0.5) = $95). The total benefit from preventing a Scenario 3 attack is then about $129 billion.
($34+$95 = $129).
If the actions undertaken as a result of this proposed rule only prevented Scenario 3 attacks, and
no foreign costs are passed on to Americans, they would have to prevent one attack every 730 years for
the benefits of the proposed rule to outweigh the costs ($129,000/$177 = 730). If all foreign costs were
passed on, the rule would have to prevent one attack every 350 years for the benefits of the proposed
rule to outweigh the costs ($129,000/$367 = 352).
Counting only the health effects and not the economic disruption, and counting domestic costs
only, the actions undertaken as a result of this proposed rule would have to prevent one Scenario 3
attack every 200 years for the benefits to outweigh the costs ($34,300/$177 = 194). With foreign costs,
the rule would have to prevent one attack every hundred years for the benefits of the proposed rule to
outweigh the costs ($34,300/$367 = 93).
3. Analysis of Uncertainty
In Table 4 of this document and elsewhere we present the expected costs of the proposed rule as
point estimates. While this is a convenient way to summarize the costs of the proposed rule and explain
our calculation, the use of point estimates neglects the large degree of uncertainty intrinsic to the
underlying analysis. In Table 5 of this document, we present the results of a Monte Carlo simulation of
uncertainty for the eventual annual costs of the proposed rule.
As we explained in the introduction to the Detailed Analysis, many parameters are defined as
probability distributions. In our Monte Carlo simulation, we use samples from the probability
25
distributions rather than using the mean values. The randomly chosen numbers are used to form a final
estimate. This procedure is repeated 10,000 times, and the results are ranked from lowest to highest. We
report the 5th percentile, mean, and 95th percentile of the simulated results:
Table 5.—Low, Mean, and High Total Cost Estimates
Initial Cost ($Mil)
Annualized 3% ($Mil)
Annualized 7% ($Mil)
5th
Percentile
$
521
$ 251
$ 260
Mean
$ 687
$ 357
$ 367
95th
Percentile
$ 860
$ 464
$ 474
26
E. Analysis of Regulatory Alternatives
We have identified six regulatory alternatives:
1. No action;
2. The proposed rule;
3. The proposed rule, but with a different definition of very small business;
4. The proposed rule, with an additional requirement that dairy farms limit access to milk
storage;
5. The proposed rule, with an additional requirement that all registered food facilities conduct
vulnerability assessments and act according to those assessments; and
6. The proposed rule, with additional requirements designed to prevent economically motivated
adulteration of foods that could cause a food safety hazard.
1. No Action
Under this option, FDA would rely on
current FDA guidances for industry (Ref. (14)),
voluntary adoption of some or all provisions of the proposed regulation,
new State and local enforcement activity to bring about a reduction of potential harm
from adulterated foods, or
the tort system, with litigation or the threat of litigation serving to bring about the goals
of the proposed rule.
This option is not legally viable because Sections 103 and 106 of FSMA require us to establish
regulations to protect against the intentional adulteration of food. Moreover, we believe that this option
would not minimize the risk of food safety hazards, including serious adverse health consequences or
death from intentional adulteration of food. The advantage of this option is that there would be no costs
to food producers, but the disadvantage is that there would also be no benefits to society.
2. The Proposed Rule
27
The costs and benefits of the actions required by the proposed rule are described in the Detailed
Analysis section above.
3. A Different Very Small Business Size than the Proposed Rule
One alternative is to choose some level other than $10 million in annual sales for the definition
of very small businesses. Choosing a higher cutoff would lower the number of facilities required to
implement the proposed rule, which would lower costs, but would result in a larger percentage of food
being produced by businesses that are not required to implement the regulation.
The following table shows the estimated number of domestic firms and facilities covered, and
total cost to domestic firms at a 7 percent discount rate, of the actions required by the proposed rule at
various definitions of very small businesses. It also shows the share that would be covered by the
regulation, where the total is defined as food produced domestically by registered facilities that are
estimated to have actionable process steps. The table was generated by using facility-level data from
Dun & Bradstreet’s Global Business Database (Ref. (3)), as described in the Detailed Analysis:
Table 6.—Other Facility Exemptions
Cutoff
($Mil)
5
10
20
30
40
50
Facilities
Covered
16,700
14,300
12,000
10,500
9,700
9,200
Firms
Covered
6,600
4,600
3,100
2,300
1,900
1,700
Total Cost
($Mil)
$ 208
$ 177
$ 149
$ 130
$ 120
$ 115
Share
Covered
98%
97%
95%
93%
92%
91%
All cost numbers are produced using the same procedures described in the Detailed Analysis
below. We do not have similar data on foreign firms, but we estimate that the number of firms and
facilities, and the total costs, would be roughly doubled if foreign firms were included.
4. The Proposed Rule with Dairy Farm Requirements
We have identified the fluid milk storage tank as a potentially significant vulnerability at a dairy
farm, and are considering whether and how access to fluid milk storage and loading in bulk tanks at
dairy farms can be limited. A requirement to limit access to the fluid milk storage tank would generate
28
additional costs, and also the additional benefit of protecting the milk supply on the farm. We estimate
the potential costs in this section, and present a breakeven analysis. The example calculations assume
that all of the approximately 49,000 dairy farms that are licensed to sell milk would be covered, and the
summary table shows how costs would change with rule coverage based on different herd sizes.
We do not know what mitigation strategies would be required by this option, but we estimate
that the primary cost of any such strategy would be to cause a loss in productivity. Farm workers, milk
truck drivers, and state milk inspectors would need to spend time gaining access to the fluid milk, and
then securing the tank or building when they leave. For example, if locks and keys are used for access
control, this will require unlocking and relocking the storage tanks and/or the building containing fluid
milk. Farm operators would have to manage and coordinate the distribution and control of keys.
Additional time would be lost if keys are lost or forgotten. Because state milk inspectors routinely
access fluid milk, and limiting access will likely make this more difficult, some costs of this option may
be borne by state milk inspection agencies.
We estimate that limiting access to milk storage tanks will result in, on average, fifteen minutes
of lost productivity per day on each farm affected by the proposed rule.6 We request comments on this
estimation. To the extent that mitigation strategies can be found that generate less loss in productivity,
the costs of this option will be lower than the costs we estimate here.
Dairy farms operate every day of the year. Fifteen minutes lost per day means 91 hours lost per
year (15*365/60 = 91.25). The mean hourly wage in the agricultural industry is $12.47 (Ref. (15)), and
we increase this by 50 percent to account for benefits and overhead, to value the time lost at $18.71 per
hour ($12.17*1.5 = $18.71). We request comments on the suitability of this value of time estimate to
dairy farms. This means that the value of the total time lost would be about $1700 per farm
($18.71*91.27 = $1,707).
In addition to this lost productivity, we estimate average initial costs of about $5,000 per dairy as
a result of this proposed rule for startup costs, such as education and training, and/or the purchase and
6
This number is based on discussions with FDA experts. We recently obtained data on the number of storage tanks
at dairy farms of different sizes, and will use that data to generate more precise estimates for the final Regulatory Impact
Analysis based on any requirements established in the final rule on this issue.
29
installation of capital equipment (Ref. (6)). We request comments on this estimation. This results in
annualized costs of about $700 per business. We then add the productivity and capital costs to estimate
an average annual cost per dairy farm of about $2,400 ($1,707+$712 = $2,419).
There are about 49,000 dairy farms licensed to ship milk commercially (Ref. (16)), so the total
annual cost of a dairy farm requirement would be about $119 million ($2,419 * 49,331 = $119,317,815).
Alternatively, the proposed rule might apply to all dairy farms, or only to dairy farms with more
than a certain number of milk-producing cows. The following table shows the cost of a dairy farm
provision at various herd size exemptions:
Table 7.—Dairy Farm Rule Costs by Coverage
Rule Coverage
All Farms
Licensed to sell
30 or more cows
50 or more cows
100 or more cows
200 or more cows
Farms
Cost
Covered ($Mil)
58,000
$ 140
49,000
$ 119
39,200
$
95
29,500
$
71
15,000
$
36
7,100
$
17
The benefits of this option would come from a reduction in the chances of public health harm as
a result of terrorist attacks on the milk supply. As with the proposed rule, we do not know how many
instances of intentional adulteration there will be in the future, or how effective the requirements would
be at stopping them. Therefore, we present a breakeven analysis. For descriptions of the scenarios, see
the Detailed Analysis.
If this provision only prevented Scenario 1 attacks, which would have an average benefit of
about $10 million per prevented attack, it would have to prevent twelve attacks every year for the
benefits to outweigh the costs ($119/$10 = 11.9).
If this provision only prevented Scenario 2 attacks, which would have an average benefit of
about $212 million per prevented attack, then it would have to prevent such an event every 1.8 years for
the benefits to outweigh the costs ($212/$119 = 1.8).
30
If this provision only prevented Scenario 3 attacks, which would have an average benefit of
about $129 billion per prevented attack, then it would have to prevent one such event every thousand
years for the benefits to outweigh the costs ($129,000/$119 = 1,081).
5. Vulnerability Assessment Requirement
Another alternative would be to require all registered food facilities to conduct their own
vulnerability assessments and craft a food defense plan according to the results of that vulnerability
assessment. This alternative would have all of the costs and benefits of the proposed rule, as well as
additional costs and benefits.
Our experience is that the most challenging part of developing a system of controls for
intentional adulteration related to terrorism is identifying the points in the food operation that are most
vulnerable to attack by performing a vulnerability assessment. Conducting vulnerability assessments is
expensive and requires the time of personnel or consultants with specialized knowledge and training.
For this option, companies may incur significant cost.
We estimate that conducting a vulnerability assessment for the average facility covered by the
proposed rule would take 40 hours by people at the level of an operations manager, and that learning
how to conduct the vulnerability assessment would require an additional 20 hours, for a total time cost
of 60 hours.
The mean hourly wage of an operations manager in the food manufacturing industry is $53.56
(Ref. (5)). We increase this cost by 50 percent to account for benefits and overhead, making the total
cost of time $80.34 ($53.56*1.5 = $80.34). This results in a cost of about $4,800 per facility ($80.34*60
= $4,820). There are about 14,300 facilities covered by the proposed rule, so the total up-front cost
would be about $69 million ($4,820*14,300= $68,733,200). This results in annualized costs of about
$12 million per year at a seven percent discount rate.
The additional benefit of this alternative is that it may provide more thorough and specialized
coverage of the vulnerabilities at each food manufacturing plant. We are unable to quantify these
benefits, and we believe that they are small relative to the costs. As explained in the preamble to the
proposed rule, FDA has conducted extensive vulnerability assessments and as a result, we determined
that the presence of one or more of four key activity types at a process step (e.g., manufacturing,
processing, packing, or holding of food) indicates a significant vulnerability and that the food is at high
31
risk of intentional adulteration caused by acts of terrorism. We do not believe that requiring individual
facility-specific vulnerability assessments will cause significant changes in the mitigation strategies
chosen or the effectiveness of those strategies, so therefore we believe that the additional costs of this
option outweigh the additional benefits. We request comments on this conclusion.
If producers expect that conducting individualized, facility-specific vulnerability assessments
would result in less costly and/or more effective measures than the ones required by the proposed rule,
they would have the option of doing this under the proposed rule. Therefore, the proposed rule already
incorporates any benefits from flexibility that this option would generate.
6. Economically Motivated Adulteration Requirements
Under this option, FDA would add provisions to this rule to prevent the profit-motivated addition
of substances that could cause a food safety hazard, like melamine, to foods.7 We are unsure what
mitigation strategies these provisions would require, but they would likely result in companies testing
certain raw ingredients for these contaminants. This option would have all of the costs and benefits of
the proposed rule, along with additional costs and benefits.
Our current thinking, as described in the preamble, is that provisions to prevent economically
motivated adulteration will be added to other rules. The cost estimates in this section should not be
applied to those other rules, because the number of facilities covered, and the potential provisions,
would be different. The estimate below is intended to be an illustrative example of what costs might be
if economically motivated adulteration was addressed in this rule.
We do not know how many contaminants would be tested for or how many firms would be
testing for them. We also do not know how frequently the tests would be conducted, or how often these
tests are currently being conducted by the industry. As an illustrative example of possible costs, we
assume that this option would require about half of the covered facilities to conduct an average of 20
additional diagnostic tests per year on incoming lots of ingredients, and that the tests would cost an
average of $100, which is the approximate current price of melamine testing (Ref. (17)). This would
7
By “economically motivated adulteration” we mean intentional adulteration that is not intended to harm
consumers. Profit-motivated intentional adulteration that is intended to harm consumers (for example, one firm attempting to
contaminate a competitor’s product) is considered terrorism and is one of the targets of this proposed regulation.
32
result in per-facility annual costs of $1,000 (20*0.5*$100 = $1,000). There are about 14,300 facilities
covered by the proposed rule, so the additional annual costs of this option would be about $14.3 million
($1,000*14,300 = $14,300,000).
The benefits of this option would come from a reduction in the chances of public health harm as
a result of profit-motivated adulteration. As with the proposed rule, we do not know how many instances
of intentional adulteration there will be in the future, or how effective the requirements would be at
stopping them. Since we have only presented an illustrative example of possible costs of such a set of
requirements, we do not conduct a breakeven analysis here.
33
Preliminary Regulatory Flexibility Analysis
The Small Business Regulatory Flexibility Act requires agencies to analyze regulatory options
that would minimize any significant impact of a rule on small entities. Small entities have fewer
resources to devote to regulatory compliance and, therefore, may be more affected by regulatory
compliance costs. The agency believes that the proposed rule will have a significant economic impact on
a substantial number of small entities.
1. Number of Small Entities Affected
The Small Business Administration defines food manufacturers as “small” according to their
number of employees. For the most part, food manufacturers employing 500 or fewer persons are
considered small businesses. However, there are some particular food manufacturing industry segments
where the employee maximum is higher (750 or 1,000 employees). For the purposes of this proposed
rule-making, we have defined a very small business as having annual sales of less than $10 million on
an annual basis, and a small business as a business employing fewer than 500 persons.
We find that there are 4,107 firms with more than $10 million in sales, and less than 500
employees, that would be covered by this proposed rule (Ref. (3)). We also find that there are 47,416
firms that have less than $10 million in sales, and are exempt from the proposed rule, but would have to
learn about the proposed rule and be prepared to document their exemption.
The facilities that are part of firms with more than $10 million in sales produce 97 percent of the
total sales volume of food produced by registered facilities that are estimated to have actionable process
steps, and the qualified facilities produce 3 percent. The proposed rule therefore covers 97 percent of the
food market that is vulnerable to terrorist attack; 3 percent of the money that consumers spend on this
type of food is spent on food that is not covered by the proposed regulation.
2. Costs to Small Entities
The annualized costs per entity due to this proposed rule for a firm affected by the rule are about
$13,000 for a one-facility firm with 100 employees. This includes learning and documentation costs of
about $1,400 per firm; actionable process steps, mitigation, monitoring, corrective action, and
verification costs of about $11,400 per facility, and worker training costs of about $340. For more
information about these numbers, see the appropriate sections of the Detailed Analysis.
34
The annualized costs for a very small business affected by the rule but exempted from its
provisions are about $63 per firm. This includes an annualized cost of about $23 to learn about the rule,
and an annual cost of about $40 to maintain documentation that was relied upon to demonstrate that the
facility meets the qualified facility exemption. For more information about these numbers, see the
appropriate sections of the Detailed Analysis.
3. Regulatory Flexibility Options
FDA is proposing that the final rule would be effective 60 days after publication in the Federal
Register, with staggered compliance dates. We recognize that businesses of all sizes may need more
time to comply with the new requirements established under FSMA. FDA believes that it is reasonable
to allow for 1 year after the date of publication of the final rule for businesses other than small and very
small businesses to come into compliance with the new requirements established under FSMA. FDA
also believes that it is reasonable to allow for 2 years after the date of publication of the final rule for
small businesses to come into compliance with the new requirements established under FSMA, and 3
years after the date of publication of the final rule for very small businesses to come into compliance
with the new requirements established under FSMA.
Therefore, as proposed, facilities, other than small and very small businesses, that are subject to
part 121 would have 1 year after the effective date to comply with proposed part 121. Small businesses
would have 2 years after the effective date to comply with proposed part 121 (see section V.A of the
proposed rule preamble for a discussion of the proposed definition of a “small business”). With respect
to very small businesses, as discussed in section V.B of the preamble, we are proposing to exempt
qualified facilities, which include very small businesses, from the requirements of proposed part 121,
except that such facilities must, upon request, provide for official review documentation that was relied
upon to demonstrate that the facility meets this exemption. Very small businesses then would have 3
years after the effective date to comply with proposed §121.5(a) (see section V.A of the preamble for a
discussion of the proposed definition of a “very small business”).
Allowing small businesses more time to comply with the requirements of the proposed rule
would save them money, but we do not know what the cost savings would be, and we do not know how
this would affect the risk of an attack on the food supply.
4. Description of Recordkeeping and Recording Requirements.
35
The Regulatory Flexibility Act requires a description of the recordkeeping required for
compliance with this proposed rule. Documentation must be established and kept for the certain
purposes described in the proposed rule. Discussion of the costs of recordkeeping, record creation, and
reporting can be found in corresponding sections of the analysis.
36
Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a
written statement, which includes an assessment of anticipated costs and benefits, before proposing “any
rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.” The current threshold after adjustment for inflation is $141million, using the
most current (2012) Implicit Price Deflator for the Gross Domestic Product. FDA has determined that
this proposed rule is significant under the Unfunded Mandates Reform Act. FDA has carried out the
cost-benefit analysis in preceding sections. The other requirements under the Unfunded Mandates
Reform Act of 1995 include assessing the rule’s effects on:
• Future costs;
• Particular regions, communities, or industrial sectors;
• National productivity;
• Economic growth;
• Full employment;
• Job creation; and
• Exports.
We have determined that this rule will not have a significant impact on any of these variables.
37
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) defines
a major rule for the purpose of congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million or more; a major increase in
costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or
significant adverse effects on the ability of United States-based enterprises to compete with foreignbased enterprises in domestic or export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, the Office of Management and Budget (OMB) has determined that this
proposed rule is a major rule for the purpose of Congressional review.
38
Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44
U.S.C. 3501-3520). A description of these provisions is given in the Detailed Analysis section of this
document with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden.
Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of information is necessary for
the proper performance of FDA’s functions, including whether the information will have practical
utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility,
and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Description: The Food and Drug Administration (FDA or we) is proposing to require domestic
and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act
to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would
be required to identify and implement focused mitigation strategies to significantly minimize or prevent
significant vulnerabilities identified at actionable process steps in a food operation. FDA is proposing
these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).
We expect the proposed rule, if finalized as proposed, would help to protect food from intentional
adulteration caused by acts of terrorism.
39
Description of Respondents: We found 14,260 food production facilities that are part of 4,624
firms with more than $10 million in annual sales and are estimated to have actionable process steps and
thus will need to comply with this proposed rule. We found 47,416 firms with less than $10 million in
annual sales that may need to show documentation of exemption.
Information Collection Burden Estimate
FDA estimates the burden for this information collection as follows:
Reporting Burden
Exemption for Food Produced by Qualified Facilities
The proposed rule would not apply to a qualified facility, except that qualified facilities would be
required to provide for official review, upon request, documentation that was relied upon to demonstrate
that the facility meets this exemption. We do not know how often facilities will need to show this
information to inspectors on an annual basis. Therefore, we do not estimate a reporting burden here.
However, we do estimate a recordkeeping burden associated with the collection and retention of this
information (see discussion of Recordkeeping Burden).
Recordkeeping Burden
Requirements for Food Defense Plan
The proposed rule under § 121.126 requires that the owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food defense plan.
The food defense plan must include:
(1) The written identification of actionable process steps as required by § 121.130;
(2) The written focused mitigation strategies as required by § 121.135(b);
(3) The written procedures for monitoring as required by § 121.140(a);
40
(4) The written corrective action procedures as required by § 121.145(a)(1); and
(5) The written verification procedures as required by § 121.150(e).
There are 4,624 firms that will need to create a food defense plan. We estimate that it will take a
one-time burden of 40 hours to create such a plan. We annualize this estimate and present the burden in
Table 8 row 1 ((40 x 4,624)/3).
Actionable Process Steps
In addition to the creation of the food defense plan at the firm level, each of the 14,260 food
production facilities covered by the proposed rule are estimated to have actionable process steps, for
which they must spend time identifying and specifying under § 121.130 for the food defense plan. We
estimate that an individual at the level of an operations manager will have a one-time burden of an
average of 7.5 hours identifying the actionable process steps in that facility. We annualize this one-time
burden and present it in Table 8 row 2 ((14,260 x 7.5 hours)/3).
Mitigation Strategies
The proposed rule requires firms to identify and implement focused mitigation strategies at each
actionable process step to provide assurances that the significant vulnerability at each step will be
significantly minimized or prevented and the food manufactured, processed, packed, or held by such
facility will not be adulterated. The proposed rule does not specify a specific number or set of focused
mitigation strategies to be implemented. Some of the covered facilities are already implementing these
mitigation strategies. The costs of these focused mitigation strategies are a mix of initial capital costs
and annual personnel costs. The average initial capital cost of these focused mitigation strategies is
about $10,000 per facility. We annualize these costs and add them to the average annual capital costs
associated with these strategies of about $2,300 per facility. We take into account that about 70 percent
of facilities already have mitigation strategies implemented. Therefore, of the 14,260 total food
41
facilities, only 30 percent of these, or 4,278 will need to incur this burden. The annualized capital costs
associated with focused mitigation strategies are then presented in Table 8 row 3 [($10,000/3) + $2,300)
x 4,278].
We estimate that physical inspection of cleaned equipment as a mitigation strategy will require
first-line supervisors and other people responsible for quality control to spend about six minutes per
inspection, and that there will be 100 to 300 inspections per year, resulting in a time cost of between 10
and 30 hours per year, per facility, or an average of 20 hours. We estimate that about 70 percent of
facilities already employ this mitigation strategy, so this cost will be borne by 30 percent of facilities.
We also estimate a one-time burden associated with establishing procedures to prohibit staff from
bringing personal items into the manufacturing area as a mitigation strategy. This one time burden will
require one individual at the level of an operations manager and one legal analyst, between one and three
hours, or an average of two hours each, per facility. We annualize this burden. Table 8 row 3 shows
the total burden of creating and implementing mitigation strategies ((20 hours + 4 hours/3) x 4,278).
Monitoring and Corrective Actions
We estimate that monitoring and documenting the focused mitigation strategies, and
implementing corrective action as needed, will require first-line supervisors and other people
responsible for quality control to spend between 100 and 300 hours per year (average 200 hours), per
facility. Table 8 row 4 shows this burden estimate (200 hours x 14,260).
Training
Personnel and supervisors assigned to actionable process steps must receive appropriate training
in food defense awareness and their respective responsibilities in implementing focused mitigation
strategies under proposed § 121.160. All training received in accordance with this section must be
42
documented in records. We estimate that the training and documentation will require between zero and
two hours, or an average of one hour, per employee when the proposed rule takes effect or when a new
employee is hired. We also estimate that between 10 percent and 50 percent, or an average of 30
percent, of all workers and supervisors in covered facilities are assigned to work at actionable process
steps. We annualize the one hour initial burden for training per worker assigned to actionable process
steps (60 minutes / 3). In addition, employee turnover in the food manufacturing industry is high, so we
estimate that turnover is about 33 percent for the covered facilities. With a turnover of 33 percent, the
annual training burden per job will be about 20 minutes per position requiring training (60 minutes x
0.33= 19.8 minutes). Adding the annual training burden to the annualized initial burden yields an annual
training burden of 40 minutes per job at an actionable process step (20 minutes + 20 minutes = 40
minutes). There are about 1.4 million employees in firms covered by the proposed rule so the total
annualized burden of the training required by the proposed rule will be about $4.8 million (40 minutes x
1,386,156 x 30% = 16,633,872 minutes or 277,231 hours). We show this burden in Table 8 row 5.
Maintaining Records
The 4,624 firms covered by the proposed rule will also face an annual burden to document
compliance with the food defense plan and update it as appropriate under proposed §§ 121.305 and
121.310. We estimate that the overall documentation will take one individual at the level of an
operations manager, and also a legal analyst between zero and ten hours, or an average of five hours
each per firm. We show this burden in Table 8 row 6 (5 hours x 4,624).
Exemption for Food Produced by Qualified Facilities
Businesses that are exempt from the proposed rule because they are qualified facilities must be
prepared to give to FDA inspectors the documentation that was relied upon to demonstrate that the
facility meets the exemption. We found 47,416 firms with less than $10 million in annual sales;
43
exempting them from the proposed rule. It is these facilities that may need to show documentation upon
request to verify their exempt or qualified facility status under proposed § 121.5 Exemptions. We
estimate that this preparation and updating of files will take one individual at the level of an operations
manager between zero and one hour, with a mean estimate of 30 minutes each year for a total annual
burden of 23,708 hours (30 minutes x 47,416). We show this burden in Table 8 row 6.
Table 8.—Estimated Annual Recordkeeping Burden
21 CFR
Section
Food Defense
Plan
§ 121.126
Actionable
Process Steps
§ 121.130
Focused
Mitigation
Strategies
§ 121.135(b)
Monitoring and
Corrective
Actions
§ 121.140(a),
§ 121.145(a)(1)
Training
§ 121.160
Records
§ 121.305,
§ 121.310
Exemption for
Food from
Qualified
facilities
§ 121.5
Total
*
No. of
Recordkeepers
No. of
Records
per
Recordkeeper
Total
Annual
Records
Average
Burden per
Recordkeeping
Total
Hours*
1,541
1
1,541
40
61,640
4,753
1
4,753
7.5
35,648
4,278
1
4,278
21.33
91,250
14,260
1
14,260
415,847
1
415,847
200
2,852,000
0.67
(40 minutes) 277,231
4,624
1
4,624
5
47,416
0.5
(30 minutes) 23,708
3,364,597
47,416
1
Total Capital
Costs*
$24,097,974
23,120
$24,097,974
There are no operating and maintenance costs associated with this collection of information.
44
Third Party Disclosure Burden
We have not identified any Third Party Disclosure burdens as a result of this proposed rulemaking.
In compliance with the Paperwork Reduction Act of 1995 (44. U.S.C. 3407(d)), the agency has
submitted the information collection provisions of this proposed rule to OMB for review. Interested
persons are requested to send comments regarding information collection by March 31, 2014 to the
Office of Information and Regulatory Affairs, OMB. To ensure that comments on information
collection are received, OMB recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or emailed to
oira_submission@omb.eop.gov. All comments should be identified with the title, “Focused Mitigation
Strategies to Protect Food Against Intentional Adulteration.”
45
References
1. FDA Food Safety Modernization Act of 2011. Pub. L. No. 111-353 §§ 103, 105, 106. 2011.
2. Agroterrorism: Where Are We in the Ongoing War on Terrorism? Tamara M Crutchley, et
al. s.l. : Journal of Food Protection, 2007.
3. Dun & Bradstreet. Dun & Bradstreet Global Business Database. 2011.
4. Food and Drug Administration. Preventative Controls for Human Food Regulatory Impact
Analysis.
5. Bureau of Labor Statistics. May 2012 National Industry-Specific Occupational Employment
and Wage Estimates . NAICS 311000 - Food Manufacturing. [Online]
http://www.bls.gov/oes/current/naics3_311000.htm.
6. Institute of Food Technologists. Modeling the Costs of Food Defense Practices: Prototype
Model. 2011.
7. Food and Drug Administration. Operational and Administrative System for Import Support
(OASIS) Database.
8. Adversarial Risk Analysis for Counterterrorism Modeling. Rios, Jesus and Insua, David
Rios. s.l. : Risk Analysis, 2012.
9. Risk Analysis of Chemical, Biological, or Radionuclear Threats: Implications for Food
Security. Mohtadi, Hamid and Murshid, Antu. 2009, Risk Analysis.
10. Analyzing a bioterror attack on the food supply: The case of botulinum toxin in milk. Wein,
Lawrence M. and Liu, Yifan. 2005, PNAS.
11. Grocery Manufacturers' Association. Capturing Recall Costs: Measuring and Recovering
the Losses. [Online] http://www.gmaonline.org/filemanager/images/gmapublications/Capturing_Recall_Costs_GMA_Whitepaper_FINAL.pdf.
12. FDA Center for Food Safety and Applied Nutrition. Risk Assessment for Food Terrorism
and Other Food Safety Concerns. 2003.
46
13. Stinson, Thomas. The National Economic Impacts of a Food Terrorism Event: Preliminary
Estimates. [Online] 2005. http://www.ift.org/knowledge-center/read-ift-publications/sciencereports/conferencepapers/~/media/Knowledge%20Center/Science%20Reports/Conference%20Papers/3Stinson.pdf.
14. Food and Drug Administration. Food Defense Guidance Documents & Regulatory
Information. [Online]
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefens
e/default.htm.
15. Bureau of Labor Statistics. May 2012 National Industry-Specific Occupational
Employment and Wage Estimates. Sector 11 - Agriculture, Forestry, Fishing and Hunting. [Online]
http://www.bls.gov/oes/current/naics2_11.htm.
16. USDA National Agricultural Statistics Service. Farms, Land in Farms, and Livestock
Operations 2012 Summary. [Online]
http://usda01.library.cornell.edu/usda/current/FarmLandIn/FarmLandIn-02-19-2013.pdf.
17. Arbro Analytical Division. Testing Rates. Melamine Testing. [Online] 2013.
http://www.melaminetesting.in/rates.html.
18. International Dairy Foods Association. Voluntary Guidelines for Security of Raw Milk at
the Farm. [Online] http://www.nmpf.org/files/file/Milkhouse_security_w_logos.pdf.
47
| File Type | application/pdf |
| File Title | Microsoft Word - IA PRIA Final Clean with PRA.docx |
| Author | DHC |
| File Modified | 2016-03-01 |
| File Created | 2016-03-01 |