0339 ss 7-23-2019

Substances Prohibited from Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant Feed
0910-0339
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
gives us the authority to issue regulations for the efficient enforcement of the FD&C Act. Our
regulation at 21 CFR 589.2000 provides that animal protein derived from mammalian tissue
(with some exclusions) is not generally recognized as safe (GRAS) for use in ruminant feed and
is a food additive subject to certain provisions of the FD&C Act (62 FR 30936, June 5, 1997).
This information collection was established because epidemiological evidence gathered in the
United Kingdom suggested that bovine spongiform encephalopathy (BSE), a progressively
degenerative central nervous system disease, is spread to ruminant animals by feeding protein
derived from ruminants infected with BSE. This regulation places general requirements on
persons that manufacture, blend, process, and distribute products that contain, or may contain,
protein derived from mammalian tissue, and feeds made from such products.
Specifically, this regulation requires renderers, feed manufacturers, and others involved in feed
and feed ingredient manufacturing and distribution to maintain written procedures specifying the
cleanout procedures or other means and specifying the procedures for separating products that
contain or may contain protein derived from mammalian tissue from all other protein products
from the time of receipt until the time of shipment. These written procedures are intended to
help the firm formalize consistent processes, and then to help inspection personnel confirm that
the firm is conducting these processes in compliance with the regulation. Inspection personnel
will evaluate the written procedure and confirm it is being followed when they are conducting an
inspection.
These written procedures must be maintained if the facility is operating in a manner that
necessitates the record, and if the facility makes changes to an applicable procedure or process
the record must be updated. Written procedures required by this section shall be made available
for inspection and copying by FDA.
We request extension of OMB approval of the recordkeeping requirement in the following
citation:
21 CFR 589.2000(e)(1)(iv) - Recordkeeping
Requirement specifying written procedures be developed and maintained to ensure separation of
mammalian protein from non-mammalian protein intended for use in ruminant feed.
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2. Purpose and Use of the Information Collection
These written procedures are intended to help the firm formalize consistent processes, and then
to help inspection personnel confirm that the firm is conducting these processes in compliance
with the regulation. Inspection personnel will evaluate the written procedure and confirm it is
being followed when they are conducting an inspection. These written procedures must be
maintained as long as the facility is operating in a manner that necessitates the record, and if the
facility makes changes to an applicable procedure or process the record must be updated. Written
procedures required by 21 CFR 589.2000(e)(1)(iv) shall be made available for inspection and
copying by FDA.
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
firms. Firms 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.
4. Efforts to Identify Duplication and Use of Similar Information.
There are no other regulations or Federal agencies that require the development and maintenance
for recordkeeping of this nature.
5. Impact on Small Business or Other Small Entities
The recordkeeping provisions are no more burdensome for small firms than for large. The
regulations require all affected parties to maintain the same records. The recordkeeping
requirements are based on the risk associated with the product. FDA aids small businesses in
complying with its requirements through the Agency’s Regional Small Business Representatives
and through the scientific and administrative staffs within the Agency. FDA also provides a
Small Business Guide on the Agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
If there is no requirement to keep these records, as there is no end-product testing available, the
agency will have only limited means to monitor compliance. Without the ability to monitor
compliance, the health of animals and the public may be put at risk.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
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 December 21, 2018 (83 FR 65681). We received one comment in support of
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the regulation.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents.
This ICR is not collecting personally identifiable information (PII) or other data of a personal
nature. The regulation requires firms involved in feed and feed ingredient manufacturing and
distribution to prepare written standard operating procedures for handling protein derived from
mammalian tissue.
In preparing this supporting statement, FDA staff consulted with the FDA Privacy Office. FDA
determined that PII is not collected and the Privacy Act of 1974 does not apply.
With regard to confidentiality, this information collection requires renderers, feed manufacturers,
and others involved in feed and feed ingredient manufacturing and distribution to maintain
written procedures specifying the cleanout procedures or other means and specifying the
procedures for separating products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until the time of shipment. FDA
expects that it may inspect such firm records from time to time and that these records may
contain confidential commercial information. To the extent 21 CFR 20.64 applies, FDA will
honor the confidentiality of any data in investigation records compiled for law enforcement
purposes. In addition, only information that is releasable under the agency’s regulations in 21
CFR part 20 would be released to the public. This information is also safeguarded by Section
301(j) of the FD&C Act and would be protected from disclosure under the Freedom of
Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)). All records and
reports maintained by FDA are kept in limited access areas.
11. Justification for Sensitive Questions.
This information collection does not involve questions of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1
21 CFR Section

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total Annual
Records

Average
Burden per
Recordkeeping

Written procedures;
320
1
320
14
589.2000(e)(1)(iv)
1
There are no capital costs or operating maintenance costs associated with this collection of information.

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Total
Hours

4,480

We base our estimate of the number of recordkeepers on inspectional data.
12b.

Annualized Cost Burden Estimate

We estimate that the average hourly wage for respondents is equivalent to a GS-11-7 level in the
locality pay area of Washington-Baltimore in 2019, approximately $39.12/hour. Increasing this
wage by 30% to account for overhead costs ($11.74), FDA estimates the average hourly cost to
respondents to be $50.86/hour. The overall estimated cost incurred by the respondents is
$227,852.80 (4480 burden hours x $50.86/hr = $227,852.80).
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
We estimate the annualized cost to the Federal government for the inspection of records to be
$59,468.80. We estimate that we expend approximately 1,280-person hours annually in
inspections. The estimated number of inspections each year is 320 and the estimated total
number of hours per inspection spent on reviewing records is 4 hours (320 inspections x 4 hours
= 1280 hours annually). We estimate the average hourly wage for personnel to complete an
inspection and review to be at the GS-13 level in the locality pay area of Washington-Baltimore
in 2019, approximately $46.46/hour. The estimated annualized cost to the Federal government is
$59,468.80 (1280 hours x $44.00 = $59,468.80).
15. Explanation for Program Changes or Adjustments
The burden has not changed from the burden shown in the current inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to tabulate and publish information from this information collection.
17. Reasons Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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