0812 IA part 121 SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Mitigation Strategies to Protect Food
Against Intentional Adulteration
OMB Control No. 0910-0812
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations. The Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the FDA Food
Safety Modernization Act (FSMA), establishes certain provisions that serve to protect against 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. To implement these provisions, regulations are codified at
21 CFR part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration.
Specifically, the regulations require that an owner, operator, or agent in charge:
o prepare and implement a written food defense plan that includes a vulnerability
assessment to identify significant vulnerabilities and actionable process steps,
mitigation strategies, and procedures for food defense monitoring, corrective
actions, and verification (§ 121.126);
o identify any significant vulnerabilities and actionable process steps by conducting
a vulnerability assessment for each type of food manufactured, processed, packed,
or held at the facility using appropriate methods to evaluate each point, step, or
procedure in a food operation (§ 121.130);
o identify and implement 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 the facility will not be adulterated. For each mitigation
strategy implemented at each actionable process step, include a written
explanation of how the mitigation strategy sufficiently minimizes or prevents the
significant vulnerability associated with the actionable process step (§ 121.135);
o establish and implement mitigation strategies management components, as
appropriate to ensure the proper implementation of each such mitigation strategy,

taking into account the nature of the mitigation strategy and its role in the
facility’s food defense system (§ 121.138);
o establish and implement food defense monitoring procedures, for monitoring the
mitigation strategies, as appropriate to the nature of the mitigation strategy and its
role in the facility’s food defense system (§ 121.140);
o establish and implement food defense corrective action procedures that must be
taken if mitigation strategies are not properly implemented, as appropriate to the
nature of the actionable process step and the nature of the mitigation strategy (§
121.145);
o establish and implement specified food defense verification activities, as
appropriate to the nature of the mitigation strategy and its role in the facility’s
food defense system (§ 121.150);
o conduct a reanalysis of the food defense plan (§ 121.157);
o ensure that all individuals who perform required food defense activities are
qualified to perform their assigned duties (§ 121.4); and
o establish and maintain certain records, including the written food defense plan
(vulnerability assessment, mitigation strategies and procedures for food defense
monitoring, corrective actions, and verification) and documentation related to
training of personnel. All records are subject to certain general recordkeeping and
record retention requirements (§§ 121.301 to 121.330).
Accordingly we are seeking OMB approval of the information collection provisions found in our
regulations under 21 CFR part 121 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The purpose of the information collection is to ensure compliance with the public health
requirements covered by agency regulations. The regulations are intended 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 are required to identify and implement
mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at
actionable process steps in a food operation.
Description of Respondents: Respondents to the collection are food production facilities with
more than $10 million in annual sales. We estimate there are 9,759 such facilities owned by
3,247 firms. We estimate there are 18,080 facilities with less than $10 million in annual sales
that will need to show documentation of their exemption status as prescribed by the regulations.

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3. Use of Improved Information Technology and Burden Reduction
The information collection does not require the use of information technology but we encourage
this approach. We expect most respondents will fulfill the information collection in electronic
format, as records must be made available upon FDA request (for inspection or to review a food
safety incident).
4. Efforts to Identify Duplication and Use of Similar Information
This information collection implements new requirements for food facilities regarding mitigation
strategies to protect food against intentional adulteration not otherwise established elsewhere.
The information compliments, but does not duplicate, other information collection provisions
associated with FSMA implementation.
5. Impact on Small Businesses or Other Small Entities
The regulations provide for exemptions to a “qualified facility,” except that the facility would be
required to provide for official review documentation that was relied upon to assert the
exemption. To assist small businesses we provided for a staggered effective date to minimize the
impact of the new requirements.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements.
Respondents must create and maintain records with appropriate frequency (e.g., hourly, weekly,
monthly, quarterly or yearly basis) to demonstrate compliance.
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
In the Federal Register of February 25, 2019 (84 FR 6009), we published a 60-day notice
soliciting public comment of the proposed collections of information. Several comments were
received in response to the notice and are summarized here. Minor comments included general
support for efforts at protecting food against intentional adulteration. Other comments, however,
questioned the estimates we ascribed to meeting the requirements found in subpart C of the
applicable regulations; food defense measures (21 CFR parts 121.126 through 121.157). The
comments offered alternative estimates ranging from few to several hours, and most correlated
this time to aspects of developing plans, conducting vulnerability assessments, and documenting
procedures, activities which we attribute to the initial review and implementation of new
regulations.

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We responded to the comments, noting that alternative compliance dates were established for the
covered entities and some have yet to be realized. In addition, to assist respondents in complying
with the requirements, we offer both agency guidance as well as an FDA Food Defense Plan
Builder, a user-friendly tool designed to help owners and operators of food facilities develop a
personalized food defense plan, which is currently under development with stakeholder input.
These and other resources are available from our website at www.fda.gov. Finally, none of the
comments appeared to question the applicability of the recordkeeping or the associated retention
requirements found in subpart D of the regulations.
While we continue to invite comment regarding our burden estimates, we note that they reflect
what we believe is representative of the industry average. This information collection covers
numerous respondents with varying facility sizes and with differing product inventories. As
compliance with the regulatory requirements continues to take effect, we will continue to
evaluate the associated information collection burden accordingly. Although we always
appreciate feedback regarding ways to improve efficiencies associated with our information
collection activities, we decline to adopt alternative burden estimates for the information
collection at this time. Rather, we retain the current estimates.
9. Explanation of Any Payment or Gift to Respondents
No remuneration is provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
Under §121.325, records are 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 collected in accordance with the regulations. After a preliminary assessment we find
that the information collection does not collect personally identifiable information (PII) and there
are no forms associated with the information collection that would require a Privacy statement
under the Privacy Act.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden for this information collection as follows:

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Table 1 – Estimated Annual Reporting Burden1
Activity;
21 CFR

No. of
Respondents,

Exemption for food from very
small businesses; § 121.5
1

No. of
Responses
per
Respondent
1

18,080

Total
Annual
Responses

Avg.
Burden per
Response

Total
Hours

18,080

.50 hrs.

9,040

There are no capital costs, or operating and maintenance costs associated with this collection.

The regulations provide for exemptions. At this time we estimate there are 18,080 firms with
less than $10 million in annual sales, exempting them from the requirements. Because facilities
must show documentation upon request to verify their exempt status under the regulations
(§121.5; exemptions), we have characterized this as a reporting burden. We estimate preparing
and updating relevant files will require an average of 30 minutes per respondent for a total
annual burden of 9,040 hours (30 minutes x 18,080), as reflected in Table 1.
Table 2—Estimated Annual Recordkeeping Burden
Activity; 21 CFR
Section
Food defense plan;
§ 121.126
Actionable process;
§ 121.130
Mitigation strategies;
§ 121.135(b)
Monitoring,
Corrective Actions,
Verification
§§ 121.140, 121.145
Training; § 121.160
Records; § 121.305,
§ 121.310
TOTAL
1

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Avg. Burden
per
Recordkeeping

3,247

1

3,247

23 hrs.

74,681

9,759

1

9,759

20 hrs.

195,180

9,759

1

9,759

20 hrs.

195,180

9,759

1

9,759

175

1,707,825

367,203
9,759

1
1

367,203
9,759

.6699 hrs.
10 hrs.

244,802
97,590

409,486

Total Hours

2,515,258

There are no capital costs, or operating and maintenance costs associated with this collection.

Under the regulations, an owner, operator, or agent in charge of a facility must prepare, or have
prepared, and implement a written food defense plan, including written identification of
actionable process steps, written mitigation strategies, written procedures for defense monitoring,
written food defense corrective actions, and written food defense verification procedures. The
estimated recordkeeping burden associated with these activities totals 2,515,258 annual
recordkeeping burden hours and 409,486 annual recordkeeping responses.
We estimate an average of 3,247 firms will continue to need to create a food defense plan under
§ 121.126, that a one-time burden of 60 hours will be needed to create a plan, and that a burden
of 10 hours will be required to update the plan. We annualize this estimate by dividing the total
number of burden hours (70) over a 3-year period as reflected in table 2, row 1.

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Under § 121.130, each of the estimated 9,759 food production facilities will identify and specify
actionable process steps for its food defense plan. We estimate that an individual at the level of
an operations manager incurs a burden of 20 hours for this activity, as reflected in table 2, row 2.
Under § 121.135(b), each of the estimated 9,759 food production facilities must identify and
implement mitigation strategies to provide assurances that any significant vulnerability at each
step is significantly minimized or prevented, ensuring that the food manufactured, processed,
packed, or held by the facility will not be adulterated. We do not specify a specific number or
set of mitigation strategies to be implemented. Some of the covered facilities are already
implementing mitigation strategies. We estimate that it requires an average of 20 hours per
facility to satisfy the recordkeeping burden associated with these activities for a total of 195,180
hours, as reflected in table 2, row 3.
We estimate that the recordkeeping activities associated with monitoring, documenting
mitigation strategies, and implementing necessary corrective actions require first-line supervisors
or others responsible for quality control an average of 175 hours for each recordkeeping, and that
these provisions apply to each of the 9,759 facilities. This results in a total of 1,707,825 annual
burden hours, as reflected in table 2, row 4.
We estimate that recordkeeping activities associated with training under § 121.60 total 244,802
annual burden hours, as reflected in table 2, row 5. We estimate that there are 1.2 million
employees working at the regulated facilities and that 30 percent of them (367,203) require
training. We estimate that the average burden for the associated recordkeeping activity is
approximately 40 minutes (or .67 hours) per record.
Finally, we estimate the 9,759 food production facilities will fulfill the recordkeeping
requirements under §§ 121.305 and 121.310, and that it will require an average of 10 hours per
record, as reflected in table 2, row 6.
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, then is $202,802,101.30 (2,524,298
burden hours x $80.34/hr).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.

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14. Annualized Cost to the Federal Government
Our review of retained records would generally occur as part of 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 will 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, we increased our
estimate 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
We retain our currently approve estimate for the information collection. We continue to evaluate
the associated activities and accompanying burden as the effective dates continue to be realized
and the regulations implemented.
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
The OMB expiration date will be displayed as required under
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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