IA Supporting Statement PR Dec 2013

Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Proposed Rule
RIN 0910-AG63
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
This proposed regulation implements three provisions of the Federal Food, Drug, and Cosmetic
(FD&C) Act, as amended by the FDA Food Safety Modernization Act (FSMA), that relate to the
intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C. 350g) addresses
intentional adulteration in the context of facilities that manufacture, process, pack, or hold food
and are required to register under section 415 of the FD&C Act (21 U.S.C. 350d). Section 419 of
the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and
vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i)
addresses intentional adulteration in the context of high risk foods and exempts farms except for
farms that produce milk. FDA is implementing the intentional adulteration provisions in sections
418, 419, and 420 of the FD&C Act in this rulemaking.
This is a new information collection for 21 CFR Part 121.
2. Purpose and Use of the Information Collection
This 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 facilities need to prepare and implement a written food defense
plan that includes actionable process steps, focused mitigation strategies, and procedures for
monitoring, corrective actions, and verification.
We expect the proposed rule, if finalized as proposed, would help to protect food from intentional
adulteration caused by acts of terrorism because domestic and foreign food facilities that are
required to register under the FD&C Act 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.
3. Use of Improved Information Technology and Burden Reduction
The proposed does not require the use of electronic recordkeeping, but we encourage this
approach. The recordkeeping required by this rule-making does not need to be submitted to FDA.
Records must be kept on hand in case FDA requests the records (for inspection or to review a food
safety incident). We expect that most of the facilities will maintain most of their records in
electronic format.

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4. Efforts to Identify Duplication and Use of Similar Information
This proposed rule would establish new requirements for food facilities. Therefore we do not
anticipate this rule-making to cause any duplication of existing requirements.
5. Impact on Small Businesses or Other Small Entities
The proposed rule would not apply to a qualified facility, except that the facility would be required
to provide for official review, upon request, documentation that was relied upon to demonstrate
that the facility qualifies for this exemption.
As proposed, a qualified facility would be: (1) A very small business (i.e., a business that has less
than $10,000,000 in total annual sales of food, adjusted for inflation), or (2) a facility that meets
two requirements, i.e., (a) During the 3-year period preceding the applicable calendar year, the
average annual monetary value of the food manufactured, processed, packed or held at such
facility that is sold directly to qualified end-users (as defined in this part) during such period
exceeded the average annual monetary value of the food sold by such facility to all other
purchasers; and (b) the average annual monetary value of all food sold during the 3-year period
preceding the applicable calendar year was less than $500,000, adjusted for inflation.
The high threshold value for annual sales, ($10 million) significantly reduces any burden of this
rule-making on small businesses. In addition, small businesses (i.e., those employing fewer than
500 persons) would have 2 years after the effective date to comply with proposed part 121. Very
small businesses (i.e., businesses that have less than $10,000,000 in total annual sales of food,
adjusted for inflation) would be considered a qualified facility and would have 3 years after the
effective date to comply with proposed §121.5(a).
6. Consequences of Collecting the Information Less Frequently
The facility will need to create and maintain records at the appropriate level (e.g., hourly, weekly,
monthly, quarterly or yearly basis) to show FDA that they are in compliance with food safety laws
and that all food safety hazards are being adequately controlled for.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
The proposed rule published in the FEDERAL REGISTER on December 24, 2013 (78 FR 78013).
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
Proposed § 121.325 would establish that all records required by proposed part 121 will be
protected from public disclosure to the extent allowable under 21 CFR part 20. Our general
policies, procedures, and practices relating to the protection of confidential or otherwise protected
information received from third parties would apply to information received under this rule.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Description of Respondents: There are 14,260 food production facilities that are part of 4,624
firms with more than $10 million in annual sales that 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.
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Activity; Proposed 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
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No. of
Recordkeeper
s

No. of
Records per
Recordkeeper

Total
Annual
Records

Avg. Burden
per
Recordkeeping

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
415,847

1
1

14,260
415,847

200
0.67

2,852,000
277,231

4,624

1

4,624

5

23,120

47,416

1

47,416

0.5

23,708
3,364,597

There are no operating and maintenance costs associated with this collection of information.

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Total Hours

Reporting Burden
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. 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 1 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 1 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 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 1 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

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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 1 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 1 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
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 1 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 1 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;
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

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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 1 row
6.
Third Party Disclosure Burden
We have not identified any Third Party Disclosure burdens as a result of this proposed rulemaking.
12b. Annualized Cost Burden Estimate
The mean hourly wage of an operations manager in the food manufacturing industry is $53.56
(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). 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 overall estimated cost incurred by the respondents is then about $270,311,723 (3,364,597
burden hours x $80.34/hr).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
21 CFR Part 121

Capital Costs

Focused Mitigation Strategies

$24,097,974

§ 121.135(b)
Total one-time capital costs

$24,097,974

14. Annualized Cost to the Federal Government
FDA’s review of the retained records would generally occur as part of its routine or for cause
establishment inspection activities. FDA estimates that its review of the retained records would
take five hours per inspection. FDA estimates the hourly cost for review and evaluation to be
$16.33 to $55.46 per hour, the GS-5/Step 1 rate to the GS 13/Step 10 rate for the WashingtonBaltimore locality pay area for the year 2012. To account for overhead, this cost is increased by
50 percent, making the total cost $24.50 to $83.19 per hour. The midpoint of this range is $53.85
per hour. Thus, FDA estimates the cost to the Federal Government for the review of records to be
$269.25 per review ($53.85/hour x 5 hours). FDA estimates that it will review records for an
average of 500 inspections per year. Thus, FDA estimates that the total annual cost to the Federal
Government for reviewing records during inspections would be $134,625 ($269.25 x 500
inspections).
15. Explanation for Program Changes or Adjustments
This is a new data collection.

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16. Plans for Tabulation and Publication and Project Time Schedule
These information collection requirements will not be published, tabulated or manipulated.
17. Reason(s) Display of OMB Expiration Date Is Inappropriate
We are not seeking approval not to display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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