0789 PC for Animal Food Supporting Statement for Final Rule

Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals
OMB Control No. 0910-0789
RIN 0910-AG10
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
This rulemaking is being issued to satisfy the requirements of the Food Safety Modernization
Act (FSMA) (Public Law 111-353) preventive controls section that modifies the Federal Food,
Drug, and Cosmetic Act. It also will meet the requirement under the FDA Amendments Act
(FDAAA) for processing standards for pet food. This rule establishes and implements hazard
analysis and risk-based preventive controls for food for animals in addition to current good
manufacturing practice in manufacturing, processing, packing, and holding of animal food. The
rulemaking applies to domestic and imported animal food (including raw materials and
ingredients) and is intended to build an animal food safety system for the future across all sectors
of the animal food system.
This information collection request supports the reporting, recordkeeping, and third-party
disclosure requirements associated with the final rule and codified in 21 CFR Part 507.
We request OMB approval for the following information collection provisions:
Reporting:
21 CFR 507.7; Exemption; submit attestation that facility is a qualified facility and attestation of
preventive controls or compliance with State and Local laws (non-Federal)
21 CFR 507.67, 507.69 and 507.71; Submission of an Appeal, including Submission of a
Request for a Formal Hearing
21 CFR 507.85; Requests for reinstatement of exemption
Recordkeeping:
Subpart A: General Provisions
21 CFR 507.7(e); Records demonstrating that the facility is a “qualified” facility
21 CFR 507.4(d); Animal food safety and hygiene training

Subpart C: Hazard Analysis and Risk-Based Preventive Controls
21 CFR 507.31-507.55; Food safety plan, including hazard analysis, preventive controls, and
procedures for monitoring, corrective actions, and verification; recall plan; validation; reanalysis;
modification; implementation records
Subpart E: Supply Chain Program
21 CFR 507.105-507.175; Written supply-chain program, including records documenting
program
Subpart F: Requirements Applying to Records
21 CFR 507.200-507.215; General requirements, additional requirements applying to food safety
plan, requirements for record retention, use of existing records, and special requirements
applicable to written assurance
Third-Party Disclosure:
21 CFR 507.27(b); Labeling that the animal food product contains specific information and
instructions
21 507.7(e)(1); Change labels on products with labels
21 CFR 507.7(e)(2); Change address on labeling (Sales Documents) for qualified facilities
21 CFR 507.25(a)(2); Animal food, including raw materials, other ingredients, and rework, is
accurately identified
21 CFR 507.28(b); Holding and distribution of human food byproducts for use as animal food
* This information collection is not related to the American Recovery and Reinvestment Act of
2009.
2. Purpose and Use of the Information Collection
This rule requires animal food facilities to establish and implement hazard analysis and riskbased preventive controls, and implement current good manufacturing practices. The regulation
includes requirements for animal food facilities to have a written food safety plan, including a
hazard analysis; a description of preventive controls (including recall procedures); a description
of monitoring procedures for those preventive controls identified; corrective action for any
failure of the preventive controls; a description of verification procedures; and recordkeeping
procedures. The information collection provisions are meant to ensure the safety of animal food
in response to the FSMA and FDAAA statutory mandates.

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Respondents to the information collection are owners, operators, or agents in charge of domestic
or foreign facilities that manufacture, process, pack, or hold food for human or animal
consumption in the United States.
3. Use of Improved Information Technology and Burden Reduction
Reporting requirements under the rule solicit what the agency believes is the minimal
information necessary. At this time the information may be submitted to FDA either
electronically or by mail, however we encourage electronic submissions. We are currently
developing both paper and electronic forms to facilitate the reporting process and expect to make
drafts available for comment in the near future. We expect most respondents will fulfill the
recordkeeping requirements under the rule electronically where facilities may format their
records in a manner they determine most appropriate.
4. Efforts to Identify Duplication and Use of Similar Information
Facilities may already maintain much of the information now required under the rule. As FDA
has been Congressionally mandated to implement this rulemaking under FSMA, we believe that
duplication of the information collection from another source is unlikely.
5. Impact on Small Business or Other Small Entities
Small businesses, defined as those with fewer than 500 employees, would not be subject to the
requirements of this rule until 2 years after publication of the final rule. Very small businesses,
defined as those facilities with gross annual sales of animal food of less than $500,000, adjusted
for inflation, would not be subject to the requirements of this rule until 3 years after publication
of the final rule.
Certain other on-farm facilities that are small and very small businesses and only engage in
manufacturing, processing, packing, or holding activities that have been determined to be low
risk on-farm activities conducted on low-risk animal food, are exempt from the hazard analysis
and preventive controls requirements. Additionally, certain animal food facilities that produce
low-acid canned foods are exempt from the microbiological hazard requirements of the hazard
analysis and preventive controls requirements, provided that they comply with 21 CFR 113.
Along with the very small businesses, other qualified facilities would also be exempt from the
hazard analysis and preventive controls requirements of this rule, but would be subject to the
requirements in subpart B (Current Good Manufacturing Practice).
Approximately 100% of respondents are private sector businesses.
6. Consequences of Collecting the Information Less Frequently
The information will be collected as often as required by the Hazard Analysis and Food Safety
Plan of the respondents’ facilities. If corrective actions are necessary, further monitoring will be
conducted. Data can be collected hourly, daily, weekly, or yearly as determined by the hazards
encountered in a particular manufacturing process.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
All of the reporting requirements are consistent with 5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a proposed rule in the Federal Register of October 29, 2013 (78 FR 64735), and
published a supplemental notice of proposed rulemaking in the Federal Register of September
29, 2014 (79 FR 58475). The final rule issued September 17, 2015 (80 FR 56169). Comments
received in response to the rulemaking are filed under Docket No. FDA- 2011-N-0922
and are addressed in the final rule (80 FR at 56331).
This rulemaking is the result of significant stakeholder engagement, beginning before the
initial proposed rule. In response to extensive stakeholder input on the proposed rule, key
provisions were revised in the supplemental notice of proposed rulemaking. After the
supplemental notice of proposed rulemaking, more outreach was conducted to the stakeholder
community to ensure that the risk-based, preventive requirements in this final rule are practical
and protective of the public health.
9. Explanation of Any Payment or Gift to Respondent
This information collection does not provide for payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
This regulation does not specify confidentiality. However, records that may be reviewed during
FDA inspections are subject to FDA regulations on the release of information in 21 CFR Part 20.
Confidential commercial information is protected from disclosure under FOIA in accordance
with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by part 20. To the extent that § 20.64
applies, we will honor the confidentiality of any data in investigation records compiled for law
enforcement purposes.
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
FDA estimates the burden associated with this final rule below. Our estimates are based
on our experience with similar information collections and in consideration of feedback during
rulemaking. More detailed information regarding our calculations may be found within the
agency’s Final Regulatory Impact Analysis (FRIA), Reference No. 60, under Docket No. FDA2011-N-0922.
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Reporting Burden
Table 1 shows the total estimated annual reporting burden associated with this final rule. This
estimate is a revision from reporting estimates found in our proposed rulemaking, reflecting an
updated count of the number of facilities registered with the Agency as animal food facilities,
and resulting in an overall decrease from our previous estimate.
Table 1 – Estimated Annual Reporting Burden
21 CFR Section; Activity

507.7 exemption: submit
attestation that facility is a
qualified facility and
attestation of preventive
controls or compliance with
State and local laws (nonFederal)
507.67, 507.69, and 507.71;
submission of an appeal,
including submission of a
request for an informal
hearing
507.85(b); requests for
reinstatement of exemption
TOTAL

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Avg. Burden
per Response

Total
Hours

1,120

.5

560

.5

280

1

1

1

4

4

1

1

1

2

2
286

Out of 7,469 animal food facilities registered with FDA, we estimate approximately 15%
(1,120) could be "qualified" facilities under the “very small business” definition as discussed in
the FRIA (Ref. 60 of the final rule), and thus eligible for certain limited exemptions under the
applicable regulations.
Section 507.5 exempts qualified facilities from subpart C and E of the regulations, which
includes all of the hazard analysis and preventive controls requirements, including supply chain
program requirements.
The number of respondents in row 1 is derived from agency estimates of the number of qualified
animal food facilities that must report their status as such a facility every 2 years. The number of
total annual responses is calculated by multiplying the number of respondents by the number of
responses submitted annually. The average hourly time burden per response found in table 34,
column 5 is based on FDA’s assumption that a facility will report its status electronically through
a Web portal maintained by FDA, and that this will take approximately 0.5 hours (30 minutes).
The estimated burden associated with the requirements under §§ 507.67, 507.69, and 507.71 of
the regulations is reflected in row 2. Based on the limited data on foodborne illness outbreaks
originating at very small animal food facilities, FDA does not expect to withdraw many qualified

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facility exemptions and expects the number of appeals to be even fewer. The estimated number
of respondents is based on the Agency’s expectation that the number of appeals will be very few.
The number of responses per respondent reflects that the rule only requires one submission per
appeal. Given that facilities must respond with particularity to the facts and issues contained in
the withdrawal order, the agency estimates an average burden of 4 hours per response.
The estimated burden associated with the requirements under § 507.85(b) is reflected in row 3.
The agency expects few, if any, requests for reinstatement of an exemption that has been
withdrawn under the regulations and thus is providing an estimate of only 1 per year at this time.
We estimate the time necessary for making such a request to be no more than 2 hours,
which includes submitting the written request and presenting information that the animal food
safety problems were adequately resolved and continued withdrawal of the exemption is not
necessary to protect public (human and animal) health.
Recordkeeping Burden

Table 2 – Estimated Annual Recordkeeping Burden
21 CFR Section 507; Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Subpart A – General Provisions
507.7(e); records attesting that
1,120
.5
the facility is a “qualified”
facility
507.4(d); documentation of
7,469
0.75
animal food safety and hygiene
training
Subpart C – Hazard Analysis and Risk-Based Preventive Controls
507.31 through 507.55; food
7,469
519
safety plan – including hazard
analysis, preventive controls,
monitoring, corrective actions,
verification, validation
reanalysis, modifications, and
implementation records.
Subpart E – Supplier Program
507.105-507.175; requirements
7,469
519
to establish and implement
program – including records
documenting program
Subpart F – Requirements Applying to Records
507.200-507.215; general
7,469
519
requirements, additional
requirements applying to food
safety plan, requirements for
record retention, use of existing
records, and special
requirements applicable to
written assurance.
TOTAL

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Total Annual
Records

Avg. Burden
per
Recordkeeping

Total Hours

560

.1

56

5,579

0.05
(2 minutes)

279

3,876,411

.10

387,641

3,876,411

.10

387,641

3,876,411

.10

387,641

11,635,372

1,163,258

Under the final rule, we estimate a total of 7,469 respondents (the number of registered animal
food facilities) are subject to recordkeeping requirements found in the applicable regulations.
Although FDA believes that, in some cases, all respondents will incur new recordkeeping
activities as a result of the final rule, we believe other provisions may apply only to certain
respondents (e.g., the manufacturer, holder, processor, distributor, etc.), depending upon the
applicable regulation. With regard to the hazard-analysis and risk-based preventive controls, the
supplier program, and the requirements applying to records under 21 CFR 507 subparts D, E, and
F respectively, we have provided a cumulative estimated burden that we believe will be incurred
by the respondents under this final rule. After allowing for implementation of the final rule and
upon seeking reauthorization for its information collection provisions, FDA will reassess its
burden estimate accordingly.
Third-Party Disclosure
Table 3 shows the estimated annual third-party disclosure burden associated with the
final rule.
Table 3 – Estimated Annual Third-Party Disclosure Burden
21 CFR Section;
Activity

507.27(b); labeling for the
animal food product contains
the specific information and
instructions needed so the food
can be safely used for the
intended animal species
507.7(e)(1); change labels on
products with labels
507.7(e)(2); change address on
labeling (sales documents) for
qualified facilities
507.25(a)(2); animal food,
including raw materials, other
ingredients, and rework, is
accurately identified
507.28(b); holding and
distribution of human food
byproducts for use as animal
food
Total

No. of
Respondents

330

No. of
Disclosures
per
Respondent
10

1,526

Total Annual
Disclosures

Avg. Burden
per Disclosure

Total Hours

3,300

0.25

825

4

6,104

1

6,104

1,329

1

1,329

1

1,329

330

312

102,960

.01

1,030

40,798

2

81,596

0.25

20,399

29,687

Under the final rule, we estimate all (7,469) respondents are subject to third-party disclosure
requirements found in the applicable regulations. The number in column 2 represents an
estimated annual number of those respondents we believe will incur third-party disclosure

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burdens under the respective regulation shown in column 1. This figure is derived from our
familiarity with third-party burden associated with similar FDA regulations. Upon
implementation of the final rule, the Agency will reevaluate its estimate accordingly.
To calculate the number of annual disclosures, we multiplied the number of respondents in
column 2 by an estimated number of disclosures in column 3. This figure represents the
estimated annual number of disclosures per respondent we attribute for the respective
requirement. To calculate the annual hourly burden, we multiplied the number of annual
disclosures by an estimated hourly burden in column 5. This figure represents the amount of
time we attribute to conducting the respective disclosure activities identified in column 1.
Section 507.7(a)(2) provides that qualified facilities must either submit to FDA attestation of
hazard identification, preventive controls implementation, and monitoring, or attestation that the
facility is in compliance with applicable non-Federal food safety law.
Section 507.7(e) requires a qualified facility that chose the latter to notify consumers of the name
and business address of the facility where the animal food was manufactured or processed (1) on
the label if a package label is required by other provisions of the FD&C Act, or (2) on labeling if
no label is required of the name and manufacturing address of the qualified facility.
Section 507.25(a)(2) provides that the management of the plant must ensure that animal food,
including raw materials, other ingredients, or rework, is accurately identified during plant
operations. (see 21 CFR 7.49, 7.42(b)(1) and (b)(2)).
Section 507.38(b)(1) and (b)(2) do not add to the estimated hourly burden because notification to
consignees is already required when a facility initiates a recall under 21 CFR 7.49, and
notification to the public is provided for under 21 CFR 7.42(b)(1) and (b)(2).
Under section 507.28(b), labeling that identifies the product by the common or usual name must
be affixed to or accompany the human food by-product for use as animal food when distributed.
The estimated number of disclosures per respondent and average burden per disclosure assumes
that 60 percent of the 67,996 domestic human food manufacturing facilities (Ref. X ) or 40,798
facilities are affected, and that two sets of labeling per facility per year will be required. We
estimate 0.25 hours per disclosure to prepare labeling, and affix to the containers of labels, for a
total of 20,399 burden hours.
12b. Annualized Cost Burden Estimate

Type of Respondent
Production worker
(45%)
Industrial
production manager
(36%)
Lab technician (1%)

Annualized Cost Burden Estimate1
Total Burden Hours Hourly Wage Rate
Total Respondent
(including overhead)
Costs
$22.61
$11,894,375
526,067
420,854

$58.07

$24,438,992

11,690

$23.03

$269,221

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Type of Respondent

Total Burden Hours

Hourly Wage Rate
Total Respondent
(including overhead)
Costs
46,762
$20.13
$941,319
35,071
$34.26
$1,201,533

Clerk (4%)
First Line
Supervisor (3%)
Consultant (5%)
TOTAL

58,452

$100

1,169,038

$5,845,200
$50,539,081

1

Labor hours and wage rates were apportioned over the Standard Occupational Classification (SOC) codes using the
Bureau of Labor Statistics (BLS) data for 2012 for NAICS 311100 – Animal Food Manufacturing.
2
This table has a rounding error of plus 1 percent.

To calculate the total respondent cost, we multiplied the percentage of each category of labor
classification by the total burden hours found in tables of section 12a. (1,169,038). We then
added the respective labor costs.
13. Estimate of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating and maintenance costs associated with this collection of
information.
14. Annualized Cost to the Federal Government
These activities will be covered by existing resource allocations. Therefore, we are estimating
zero cost to the Federal government as a result of this rulemaking.
15. Explanation of Program Changes or Adjustments
This is a new information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.
17. Reason Display of OMB Expiration Date Is Inappropriate.
There is no reason not to display OMB expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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