0627 Supporting Statement 2015

Substances Prohibited from Use
in Animal Food or Feed (21 CFR Part 589)
SUPPORTING STATEMENT
OMB Control No. 0910-0627
A.

JUSTIFICATION

1. Circumstances Making the Information Collection Necessary
Section 701(a) (21 U.S.C. 371(a)) of the Federal Food, Drug, and Cosmetic Act (the act)
gives us the authority to issue regulations for the efficient enforcement of the act. On
June 5, 1997, we issued a final rule which amended 21 CFR 589.2000 to provide 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 act. The rule placed 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.
We took this action 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. While BSE had yet to be diagnosed in the United
States, measures were necessary to prevent the establishment and amplification of this
fatal disease in this country and thereby minimize any risk which might be faced by
animals and humans.
In 2003, two cows tested positive for BSE, one in Canada and the other in the state of
Washington. An epidemiological investigation and DNA test results confirmed that the
Washington state cow was born and most likely became infected in Alberta, Canada,
prior to Canada's 1997 implementation of a ban on feeding mammalian protein to
ruminants. Several BSE positive cows were found in Canada from 2004-2006; in June of
2005, a 12-year-old beef cow, born and raised in Texas, tested positive for BSE. This
was the first instance of BSE infection of a cow native to the United States.
The cases of BSE detected in Canada and the United States provide evidence of the risk
of BSE in North America. The U.S. and Canadian feed bans implemented in 1997 were
intended to address uncertainty about whether BSE was present in the cattle population of
either country. While we continue to believe that compliance with the feed regulation
has provided strong protection against the spread of BSE, the agency believes that the
recent cases are an indication that additional animal feed protections are needed.
Therefore, we believe that it was appropriate to propose certain additional measures in
October 2005. More than 800 comments were received from industry, trade associations,
government entities, and consumers. The final rule, which published April 25, 2008 (73
FR 22720), prohibits the use of certain cattle origin materials in the food or feed of all
animals. These materials include the following: (1) the entire carcass of bovine

spongiform encephalopathy (BSE)-positive cattle; (2) the brains and spinal cords from
cattle 30 months of age and older; (3) the entire carcass of cattle not inspected and passed
for human consumption that are 30 months of age or older from which brains and spinal
cords were not removed; (4) tallow that is derived from BSE-positive cattle; (5) tallow
that is derived from other materials prohibited by this rule that contains more than 0.15
percent insoluble impurities; and (6) mechanically separated beef that is derived from the
materials prohibited by this rule.
This is a request for OMB approval of the following information collection requirements:
21 CFR 589.2001 (c)(2)(ii) and (vi)- Recordkeeping – Requirement for renderers that
manufacture, process, blend or distribute cattle materials prohibited in animal feed
(CMPAF) or products that contain or may contain CMPAF to maintain adequate written
procedures specifying how they remove brain and spinal cord from cattle not inspected
and passed for human consumption, or how they separate such animals based on whether
or not they are 30 months of age or older. Renderers in this category must also maintain
records sufficient to track CMPAF to ensure such material is not introduced into animal
feed. Records are to be made available for FDA inspection and copying, and are to be
retained for a minimum of 1 year.
21 CFR 589.2001 (c)(3)(i) – Recordkeeping – Requirement for renderers that
manufacture, process, blend or distribute any cattle materials, to establish
and maintain records sufficient to demonstrate that material rendered for use in
animal feed was not manufactured from, processed with or does not otherwise
contain CMPAF. For renderers that receive cattle materials from a supplier, such records
are considered sufficient if they include either (1) certification or other documentation
from the supplier that material supplied to the renderer does not include CMPAF,
provided that it includes a description of the segregation procedures used, documentation
that the supplier confirms that its segregation procedures are in place prior to supplying
any cattle material to the renderer, and records of the renderers periodic review of the
suppliers’ certification or other documentation; or (2) Documentation of another method
acceptable to FDA, such as third-party certification, for verifying that suppliers have
effectively excluded CMPAF. Records are to be made available for FDA inspection and
copying, and are to be retained for a minimum of 1 year.
21 CFR 589.2001(c)(3)( i ) ( A ) and ( B ) – Recordkeeping
Documentation of another method acceptable to FDA, such as third party certification,
for verifying that suppliers have effectively excluded CMPAF. Records are to be made
available for FDA inspection and copying and are to be retained for a minimum of 1 year.
21 CFR 589.2001(b)(1) and 21 CFR 589.2001(f)—Reporting— Requirement that any
foreign country seeking a designation from FDA that such country, due to a low BSE risk
in that country, is not subject to the restrictions applicable to CMPAF must submit a
written request to the agency. The written request has to include sufficient scientific
evidence to support the claimed BSE risk status.

2. Purpose and Use of the Information Collection
These records are subject to inspection by Federal and State agencies to ensure that
animal food or feed does not contain protein which may cause the spread of BSE in this
country.
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 have the option of using information technology if they
wish.
4. Efforts to Identify Duplication and Use of Similar Information
There are no other regulations or Federal agencies that require the development and
maintenance of recordkeeping of this nature.
5. Impact on Small Business or Other Small Entities
The reporting & 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.
6. Consequences of Collecting the Information Less Frequently
If there are no requirements for reporting and recordkeeping, the Agency will have
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 Guideline 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), FDA published a 60-day notice in the Federal
Register of November 21, 2014 (79 FR 69493). One comment was received; however, it
did not respond to any of the four information collection topics solicited and is, therefore,
not addressed by the agency. At the same time, upon closer examination by the agency,
we have eliminated the operating and maintenance costs associated with the
recordkeeping requirements that were identified in both our 60-day and 30-day Federal
Register notices. These costs reflect costs associated with implementation of the
recordkeeping requirements and we believe that they have now been realized since the
effective date of the rule (April 27, 2009).

9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents.
Confidentiality of information will be safeguarded within the provisions of FDA’s public
information regulations in 21 CFR Part 20,
11. Justification for Sensitive Questions.
This information collection does not involve any questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs.
FDA estimates the burden for this information collection as follows:
12a. Annualized Burden Hour Estimate
Table 1- Estimated Annual Reporting Burden¹
21 CFR Section
589.2001(f)

No. of
Respondents

Total Annual
Responses

Avg. Burden
per Respondent

Total
Hours

1

No. of
Responses per
Respondent
1

One-time (initial)
burden
Burden from future
review

1

80

80

1

1

1

26

26

¹ There are no capital costs or operating and maintenance costs associated with this collection.

There is a one-time reporting burden to countries that apply to FDA seeking to be
designated as not subject to the restrictions applicable to CMPAF (§589.2001(b)(1) and
§589.2001(f)). We estimate that each country that applies for an exclusion will spend 80
hours putting information together to submit to FDA. Table 1, row 1, of this document
presents the one-time burden expected for countries that apply for the exclusion, and row
2 of the Table shows the recurring burden.

Table 2 -. Estimated Annual Recordkeeping Burden ¹
21 CFR Section 589.2001;
Substances Prohibited from
Use in Animal Food or
Feed
589.2001(c)(2)(vi) and
(c)(3)(i)
589.2001 (c)(2)(ii)
589.2001(c) (3)(i)(A)
TOTAL

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden
per
Recordkeeper

Total
Hours

175

1

175

20

3,500

50
175

1
1

50
175

20
26

1,000
4,550
9,050

¹There are no capital costs or operating and maintenance costs associated with this burden

The recordkeeping requirement in §589.2001(c)(2)(vi) applies to a limited number of
renderers who handle prohibited bovine material. We estimate that no more than 50 of
the approximately 175 rendering firms are involved in the handling of this material.
Although we may consider the distribution records needed to comply with this regulation
“usual and customary” and thus not subject to the PRA, we believe there is a burden
associated with setting up a system to ensure such records are sufficient to address the
proposed recordkeeping requirement. Likewise, although we may consider the records
necessary to comply with §589.2001(c)(3)(i) as “usual and customary” and not subject to
the PRA, we are including a burden estimate to cover establishment of a system to ensure
existing receipt and manufacturing records adequately address this requirement.
12b. Annualized Cost Burden Estimate
Type of Respondent

Total Burden Hours

Compliance Officer

106

Hourly Wage Rate
$38

Total Respondent
Costs
$4,028

As indicated in Table 1 above, this regulation provides for a country to submit an
application requesting a designation as not being subject to the restrictions on the use of
CMPAF. FDA estimates the hour burden costs to respondents choosing to submit a
request for designation to be $4,028. We calculated this estimate by multiplying the total
burden of 106 hours times the hourly wage of a compliance officer ($38), the private
employee equivalent to which we believe best represents the approximate cost of
preparing and submitting the request for designation.
13. Estimate of Other Total Cost Burden to Respondents
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
The regulation requires the expenditure of additional funds by the Federal or State
government, but the increased expenditures are not significant. The tissues that are
included on the list of cattle materials prohibited in animal feed due to this regulation
increase the number of inspections or the length of time necessary to inspect an
establishment to verify compliance with the new requirements. However, the number of
establishments inspected is not substantially changed as a result of this rule. All
establishments that are inspected for compliance under §589.2001 are already subject to
§589.2000 or other Federal rules.
However, the regulation requires some additional cost to the government for the review
of the estimated 1 original applications from foreign governments for country exclusion
designation and 1 recurring annual review of such exclusion designations. The estimated
time for reviewing and evaluating these applications by FDA personnel is approximately
50 hours per original application and approximately 17 hours for recurring annual review

of exclusion designations. Therefore, the cost to the Federal Government is estimated to
be $3,350 (67 hours times $50/hour—the average GS-13 wage rate).
15. Explanation of Program Changes or Adjustments
The total burden for this collection has been adjusted to reflect that the number of
countries submitting an application requesting a designation as not being subject to the
restrictions on the use of CMPAF has decreased, as has the number of recurring annual
reviews of exclusion designations. This has resulted in an overall decrease to the
collection by 958 hours. Also, upon closer examination by the agency, we have
eliminated the operating and maintenance costs associated with the recordkeeping
requirements that were identified in both our 60-day and 30-day Federal Register notices.
These costs reflect costs associated with implementation of the recordkeeping
requirements and we believe that they have now been realized since the effective date of
the rule (April 27, 2009).
16. Plans for Tabulation and Publication and Project Time Schedule
Not applicable.
17. Explain the reasons that display of the expiration date for OMB approval of the
information collection would be inappropriate
Not applicable.
18. Exceptions to Certification for Paperwork Reduction Submissions
There are no exceptions to the certification.