OMB 0910-0339

**SUPPORTING STATEMENT**

Substances Prohibited from Use in Animal Food or Feed;

Animal Proteins Prohibited in Ruminant Feed

A. JUSTIFICATION

1\. [Circumstances Making the Information Collection
Necessary]{.underline}

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, l997, 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.

We took this action because epidemiological evidence gathered in the
United Kingdom suggests 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 rule 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.

This is a request for 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.

2\. [Purpose and Use of the Information]{.underline}

These records would be subject to inspection by Federal and State
agencies to assure that ruminant feed does not contain protein derived
from mammalian tissues. Records must be retained for a 2 year minimum
period.

3\. [Use of Information Technology and Burden Reduction]{.underline}

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.]{.underline}.

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]{.underline}

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.

6\. [Consequences of Collectiing the Information Less
Frequently]{.underline}

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 Guideline of 5 CFR
1320.5]{.underline}

All of the reporting requirements are consistent with 5 CFR 1320.5.

8\. [Efforts to Obtain Comments on the Information Collection Before
Submission to OMB]{.underline}.

We published a 60 day notice in the Federal Register on October 3, 2003,
soliciting comments on the recordkeeping requirements placed on handlers
of ruminant proteins, to ensure separation of mammalian protein from
non-mammalian protein intended for us in ruminant feed. No comments were
received.

9\. [Explaination of Any Payment or Gift to Respondents]{.underline}

This information collection does not provide for payment or gifts to
respondents.

10\. [Assurance of Confidentiality Provided to Respondent]{.underline}.

Confidentiality of information will be safeguarded within the provisions
of FDAs public information regulations in 21 CFR Part 20,

11\. [Justification for Sensitive Questions]{.underline}.

This information collection does not involve any questions of a
sensitive nature.

12\. [Estimates of Hour Burden Including Annualized Hourly
Cost.]{.underline}

Firms (renderers, blenders, and feed manufacturers and distributors)
that handle animal protein products from both mammalian and
non-mammalian sources, and that intend to keep the products separate,
have certain requirements related to their source of mammalian material;
the need for separate facilities or cleanout procedures; and the need
for standard operating procedures (SOPs). Similar requirements would
apply to firms that handle feeds containing animal protein products from
both mammalian and non-mammalian sources, and that intend to keep the
feeds separate.

The recordkeeping burden in the following table has been estimated using
the typical average size establishment that handles animal protein from
both mammalian and non-mammalian sources, or feeds containing these
products, which in both instances, are kept separate. Our estimate of
the number of recordkeepers that separate mammalian and non-mammalian
materials is derived from inspectional data of firms handling animal
protein for use in animal feed. The annualized hourly burden for
recordkeeping under 21 CFR 589.2000 (e)(1)(iv) is estimated as follows:

Estimated Annual Recordkeeping Burden

  -------------------- ------------- ------------ ----------- ---------- ------- -- ----
                                                                                    

  21 CFR Section       No. of        Annual       Total       Hours per  Total      
                       Respondents   Frequency    Annual      Response   Hours      
                                     per          Responses                         
                                     Respondent                                     

  589.2000(e)(1)(iv)   400           1            400         14         5600       
  -------------------- ------------- ------------ ----------- ---------- ------- -- ----

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

13\. [Estimate of Other Total Cost Burden to Respondents and
Recordkeepers]{.underline}

There are no additional costs associated with this collection of
information.

14\. [Annualized Cost to the Federal Government]{.underline}Records
would be inspected during the agencys normal course of business, either
during routine or for cause inspections. In addition some of these
inspections would be carried out under contract or in partnership with
state agencies.

> Estimated total number of hours per inspection spent on reviewing
> records = 4 hours.
>
> Estimated number of inspections each year = 400
>
> Estimated total cost to the Federal government would be \$48,000 per
> year (400 inspections x 4 hours x \$30/hour (hourly cost is based on a
> GS-13 salary)).
>
> 15\. [Explaination of Program Changes or Adjustments]{.underline}
>
> Inspection data finds the total to be approximately 400 compared to
> 1,030 three years ago. The difference results from less firms
> attempting to separate mammalian and non-mammalian protein.
>
> 16\. [Plans for Tabulation and Publication and Project Time
> Schedule]{.underline}
>
> [.]{.underline}Not applicable.
>
> 17\. [Explain the reasons that display of the expiration date for OMB
> approval of the information collection would be
> inappropriate]{.underline}
>
> .Not applicable.