0789 PCAF SSA 2018 Ext

0789 PCAF SSA 2018 Ext.pdf

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

OMB: 0910-0789

Document [pdf]
Download: pdf | pdf
United States Food and Drug Administration
Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals
OMB Control No. 0910-0789
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
As amended by the Food and Drug Administration (FDA) Food Safety Modernization
Act (FSMA) (Pub. L. 111-353), the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) enables FDA to better protect the public health by helping to ensure the safety and
security of the food supply. It enables FDA to focus more on preventing food safety
problems rather than relying primarily on reacting to problems after they occur. FSMA
recognizes the important role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food production.
Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act sets forth requirements for
hazard analysis and risk-based preventive controls for facilities that produce food for
animals. To implement these provisions, regulations were codified under 21 CFR part
507--Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based
Preventive Controls For Food For Animals. The regulations establish requirements for a
written food safety plan; hazard analysis; preventive controls; monitoring; corrective
actions and corrections; verification; supply-chain program; recall plan; and associated
records.
The regulations in 21 CFR part 507 require animal food facilities to establish and
implement hazard analysis and risk-based preventive controls, and implement current
good manufacturing practice. The regulations include requirements for animal food
facilities to have a written food safety plan, including a hazard analysis; a description of
preventive controls (including recall procedures) for hazards requiring a preventive
control; a supply-chain program (if applicable); a description of monitoring procedures
for those preventive controls; a description of corrective actions for any failure of the
preventive controls; a description of verification procedures; and recordkeeping
procedures. The information collection provisions are necessary to ensure the safety of
animal food in response to the FSMA and FDAAA statutory mandates. The records are
used by respondents and FDA to verify, for example, that hazards have been identified,
appropriate control measures have been implemented and are effective, and that
appropriate corrective actions were taken if the control measures were not implemented
or a problem occurred.
Accordingly, we are requesting extension of OMB approval for the information
collection provisions found in 21 CFR part 507 and discussed in this supporting
statement.

2. Purpose and Use of the Information Collection
The required records are used by both the respondents and the FDA. The records are
used to verify that appropriate control measures have been implemented and are
effective, and that appropriate corrective actions were taken if the control measures were
not implemented or a problem occurred. Such verification activities are essential to
ensure that preventive controls are working as planned. We review the records during the
conduct of periodic facility inspections. This permits us to determine whether the animal
food has been consistently manufactured/processed, packed, or held in conformance with
appropriate preventive controls requirements.
Description of Respondents: Respondents to this information collection are owners,
operators, or agents in charge of domestic or foreign facilities that manufacture, process,
pack, or hold food for animal consumption in the United States. Respondents are from
the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic,
mechanical, or other technological techniques or other forms of information technology
as necessary for use by facilities. Facilities are free to use whatever forms of information
technology may best assist them in retaining the appropriate records and making them
available to regulatory officials. We estimate that about ninety percent (90%) of
respondents will keep some of the required records electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Each facility is responsible for the
required labeling and recordkeeping associated with the animal food it
manufactures/processes, packs, or holds. We are unaware of similar recordkeeping
requirements that could substitute for those established by the applicable regulations.
5. Impact on Small Businesses or Other Small Entities
The information collection does not impose undue burden on small entities. We provided
for extended and staggered compliance dates for respondents qualifying as small
businesses. Similarly, “very small businesses,” defined as those businesses (including
subsidiaries and affiliates) averaging less than $2.5 million, adjusted for inflation, per
year, during the 3-year period preceding the applicable calendar year in sales of animal
food plus the market value of animal food manufactured, processed, packed, or held
without sale (e.g., held for a fee or supplied to a farm without sale), are not required to
comply with subpart B of this rule until 2018, and are not required to submit attestations
as a qualified facility until 2019.
Finally, 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

2

determined to be low-risk activity/animal food combinations, are exempt from the hazard
analysis and preventive controls requirements. Also, 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 are in
compliance with 21 CFR part 113. Along with the very small businesses, other qualified
facilities are exempt from the hazard analysis and preventive controls requirements of
this rule, but are subject to the requirements in subpart B (Current Good Manufacturing
Practice) and related requirements in subpart A (see 21 CFR 507.4).
We aid small businesses in complying with our requirements through our Regional Small
Business Representatives and through the scientific and administrative staffs within the
agency. We have provided a Small Business Guide on our website at
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The information is collected consistent with the
Food Safety Plan of the respondents’ facilities. Data may be collected hourly, daily,
weekly, or yearly as determined by each facility’s Food Safety Plan. Less frequent
recordkeeping would reduce or nullify the effectiveness of the regulations to provide
assurance to both the facility and FDA that the animal food is safe. We do not collect
records as a routine matter. Records remain on file at each facility or offsite if accessible
within 24 hours. We would examine the records during a periodic inspection or during
an investigation.
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
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment
in the Federal Register of May 24, 2018 (83 FR 24124). Although three comments were
received, none were responsive to the four collection of information topics solicited and
were therefore not addressed.
9. Explanation of Any Payment or Gift to Respondents
The information collection does not provide for payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
This regulation does not provide pledges of 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

3

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
We estimate our burden of the information collection as follows:
Table 1.--Estimated Annual Reporting Burden
21 CFR Section; Activity
No. of
No. of
Total
Respondents
Responses
Annual
per
Responses
Respondent
1,120
0.5
560
507.7 exemption: submit
attestation of preventive controls
or compliance with State and local
laws (non-federal)
507.67, 507.69, and 507.71;
1
1
1
submission of an appeal, including
submission of a request for an
informal hearing
507.85(b); requests for
1
1
1
reinstatement of exemption
Total

Average
Burden per
Response
0.5
(30 minutes)

280

4

4

2

2

Table 2.--Estimated Annual Recordkeeping Burden
No. of
No. of
Total
Average
Recordkeepers Records per
Annual
Burden per
Recordkeeper
Records
Recordkeeping
Subpart A--General Provisions
507.7(e); records attesting
1,120
0.5
560
0.1
that the facility is a
(6 minutes)
"qualified" facility
507.4(d); documentation
7,469
0.75
5,579
0.05
of animal food safety and
(3 minutes)
hygiene training
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
7,469
519 3,876,411
0.1
507.31 through 507.55;
(6 minutes)
food safety plan-including hazard analysis,
preventive controls,
monitoring, corrective
actions, verification,
21 CFR Section; Activity

4

Total
Hours

286
Total
Hours

56
279

387,641

21 CFR Section; Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeeping

Total
Hours

validation reanalysis,
modifications, and
implementation records.
507.105 through 507.175;
written supply-chain
program--including
records documenting
program
507.200 through 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.
Totals

Subpart E--Supply-Chain Program
7,469
519 3,876,411

Subpart F--Requirements Applying to Records
7,469
519 3,876,411

11,635,372

0.1
(6 minutes)

387,641

0.1
(6 minutes)

387,641

1,163,258

Table 3.--Estimated Annual Third-Party Disclosure Burden
21 CFR Section; Activity
No. of
No. of
Total
Average
Total
Respondents
Disclosures
Annual
Burden per Hours
per
Disclosures Disclosure
Respondent
330
10
3,300
0.25
825
507.27(b); labeling for the animal
(15
food product contains the specific
minutes)
information and instructions needed
so the food can be safely used for
the intended animal species
507.7(e)(1); change labels on
1,526
4
6,104
1 6,104
products with labels
507.7(e)(2); change address on
1,329
1
1,329
1 1,329
labeling (sales documents) for
qualified facilities
330
312
102,960
0.01 1,030
507.25(a)(2); animal food,
(36
including raw materials, other
seconds)
ingredients, and rework, is
accurately identified
507.28(b); holding and distribution
40,798
2
81,596
0.25 20,399
of human food byproducts for use
(15
as animal food
minutes)
Total
29,687

5

These figures are based on our regulatory impact analysis in support of the final rule for
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals, which published in the Federal Register of September 17,
2015 (80 FR 56170). Using Agency data, we estimated the number of animal food
facilities that we believe are subject to the regulations. We base our estimate of the time
necessary for the individual reporting, recordkeeping, and third-party disclosure activities
on our experience with similar information collections.
12b. Annualized Cost Burden Estimate
"Type of
Respondent"
Clerk (4%)
First Line
Supervisor (3%)
Consultant (5%)
Total

Total Burden
Hourly Wage Rate
Total Respondent
Hours
Costs
46,762
$22.40
$1,047,468.80
35,071
$31.62
$1,108,945.02
58,452

$69.34

$4,053,061.68

1 May

2017 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor,
Bureau of Labor Statistics (https://www.bls.gov/oes/current/naics4_311100.htm) hourly wage plus 30% adjusted for
benefits.

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.
14. Annualized Cost to the Federal Government
Costs to the Federal government are covered by existing resource allocations.
15. Explanation for Program Changes or Adjustments
We are retaining the currently approved burden estimate. The final rule establishing the
need for the information collection became effective November 16, 2015, however
compliance dates were staggered for small and very small businesses. As a result of the
continued implementation of the regulatory provisions, we continue to evaluate and invite
comment on the estimated burden associated with the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date is appropriate.

6

18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

7


File Typeapplication/pdf
File TitleMicrosoft Word - 0789 PCAF SSA 2018 Ext.doc
AuthorDHC
File Modified2018-08-29
File Created2018-08-29

© 2024 OMB.report | Privacy Policy