SUPPORTING STATEMENT

Request for Information from U.S. Processors That Export

to the European Community

A. JUSTIFICATION

1\. [Circumstances that make the information collection
necessary.]{.underline}

The European Community (EC) is the group of fifteen European countries
that have agreed to harmonize their commodity requirements to facilitate
commerce among the member states. Ten additional countries will join the
EC in May 2004. The U. S. Department of Agriculture and the Food and
Drug Administration (FDA) have negotiated a trade agreement with the EC
on sanitary measures to protect public and animal health in the trade of
live animals and animal products. The Council of the EC has issued
Directives which contain the rules and procedures which must be followed
by the member countries for intra community trade as well as
intercommunity trade. Within these directives are requirements for
certificates to accompany each shipment of animal derived products
imported into the EC and for the producers/ processors to be on a list
which is established by the member country or non-EC country. The
following directives are applicable for those commodities for which the
FDA is the responsible federal agency:

EC Council Directive 92/46/EEC - milk and milk based products

EC Council Directive 92/45/EEC - wild game meat

EC Council Directive 91/495/EEC with 92/118/EEC - farmed game meat

EC Council Directive 92/5/EEC with 92/118/EEC and 77/99/EEC - meat
products including those derived from game meat

EC Council Directive 94/65/EC - meat products derived from game meat

EC Council Directive 91/371/EEC, Council Regulation EEC N 1907 and
Commission Regulation 1274/91 with Council Directive 92/118- shell eggs

EC Council Directive 92/118/EEC - animal casings

EC Commission Decision 99/724/EC - amends 92/118/EEC -- gelatin

EC Commission Decision 2003/42/EC -- Collagen

Dates have been established at which time importation of commodities
from the United States and other non-EC countries will be subject to the
minimum requirements of these directives.

Therefore, the FDA has established lists of processing firms for the
commodity areas of dairy products, shell eggs, game meat and game meat
products, animal casings, gelatin and collagen. These lists are not a
requirement of any US regulation but are of the EC directives. U.S.
companies are exporting these commodities to EC member countries. These
lists must be maintained as processors and products of trade will
change.

The establishment of the processor lists for the EC involves answering
the following questions:

1\) business name and address,

2\) name and telephone number of person designated as business contact,

> 3\) list of products presently being shipped to the EC and those
> intended to be shipped in the next two years,

4\) name and address of manufacturing plant for each product and

5\) names and affiliations of any federal, state or local governmental
agencies that inspect the plant, government-assigned plant identifier,
such as plant number, and last date of inspection.

> 6)assurances that the firm or individual representing the firm and
> submitting a certificate for signature to FDA is aware of and knows
> that they are subject to the provisions of Title 18, Chapter 47
> Section 1001, United States Code (U.S.C.). This statue states that it
> is a criminal offense to knowingly and willfully make a false and
> fraudulent statement or to make or use a false document in any manner
> within the jurisdiction of a department or agency to a department or
> agency of the United States or to knowingly and willfully falsify,
> conceal, or cover up any trick, scheme or device a material fact in
> any matter within the jurisdiction of a department or agency of the
> United States.
>
> 7\) assurances that the firm or individual is familiar with the EC
> directives and is in compliance with their requirements.

FDA inspects firms in the affected product categories periodically, and
as such its information on the full scope of firms exporting these
products and which products they are exporting to the EC is not current.
The Department of Agriculture or state agencies perform voluntary
inspection and grading of some of these products. Thus FDA needs to
periodically update the processor list required by the EC to facilitate
trade with the EC.

Inclusion on a list is voluntary. However, commodities from firms not on
these lists have been detained at the EC port of entry.

2\. [Indicate how, by whom, and for what purpose the information is to
be used.]{.underline}

The information obtained would be used by the FDA to update and maintain
the lists presently required by the EC directives for trade with the
U.S. The updated lists of US firms would be given to the EC periodically
to facilitate trade. Under present EC policy the lists would be
published in the Official Journal of the European Community. Without the
list, trade of the US animal derived commodities under FDA\'s
jurisdiction could be detained at the EC port of entry. In the past,
seafood shipments and dairy shipments from firms not on the seafood or
dairy list were detained and not allowed into the EC.

3\. [Indicate the extent to which information technology is
applicable.]{.underline}

Companies or individuals will be free to use whatever form of
information technology is available and convenient for them to use. This
will include mail, facsimile and e-mail. This should reduce the burden
of the firms to report the information by allowing them to use the
easiest method for the firm.

4\. [Describe efforts to identify duplication.]{.underline}

Lists of processors that export their commodities to the EC were
established but processors and commodities change. These changes in
exporters and commodities are not regularly maintained within the FDA.
The Food Safety Inspection Service (FSIS) and the Agricultural Marketing
Service (AMS) of the U. S. Department of Agriculture (USDA) perform some
voluntary inspection and grading of the commodities but maintains no
lists of those companies that export to the EC. If the records of
certificates were reviewed at the circuit or branch level of FSIS and
AMS a partial updating list might be obtained. This would not be easily
obtained nor would it include those firms that do not use these
services. Animal and Plant Health Inspection Service of the USDA has
signed some certificates in the past and maintains no records of these
certificates. Some states have signed certificates for game meat but it
is not completely known which states have been involved. Additionally
prior to the EC completion of the harmonization and implementation of
the regulation for trade with non-EC countries, some US firms were able
to export to specific countries without certificates.

5\. [Impact on small business]{.underline}

The impact on any business large or small would be the small amount of
time required to answer the seven questions asked of them.

6\. [Describe the consequences to Federal programs or policy activities
if the collection is not conducted]{.underline}

The collection is strictly voluntary. It is not required by any current
U. S. regulation. The lists are required by the EC for specific
commodities of animal origin to enter into any of the EC member states.
The impact is on the US exporters of dairy, shell eggs, animal casings,
gelatin, collagen and game meat and game meat products with the
detaining of commodities at the EC port of entry.

7\. [Explain any special circumstances to the information
collection]{.underline}

Not applicable

8\. [Describe the efforts to obtain comments on the information
collection before submission to OMB]{.underline}

In the Federal Register of April 16, 2004 (69 FR 20630), the FDA
solicited comments from the public on the collection of information. No
comments were received.

9\. [Explain any decision to provide payment or gift to
respondents.]{.underline}

The information collection does not provide for any gift or payment to
respondents.

10\. [Describe any assurance of confidentiality]{.underline}

This information collected is to be used in the formation of lists to be
transmitted to the EC in order to facilitate trade. This lists are
published in the Official Journal of the European Community and
therefore are not confidential.

11\. [Provide additional justification for any questions of a sensitive
nature]{.underline}

The information to be collected is not of a sensitive nature.

12\. [Provide estimates of the hour burden of the collection of
information]{.underline}

FDA estimates the burden for this collection as follows:

+-------------+---------+--------------+---------+---------+--------+
| Table 1     |         |              |         |         |        |
| Estimated   |         |              |         |         |        |
| Annual      |         |              |         |         |        |
| Reporting   |         |              |         |         |        |
| Burden      |         |              |         |         |        |
+=============+=========+==============+=========+=========+========+
| []{.mark}   | No. of  | No. Of       | Total   | Hours   | Total  |
|             | Resp    | Responses    | Annual  | per     | Hours  |
| Products    | ondents | per          | Re      | R       |        |
|             |         | Respondent   | sponses | esponse |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 10      | 1            | 10      | 0.25    | 2.5    |
|             |         |              |         |         |        |
| Shell Eggs  |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 100     | 1            | 100     | 0.25    | 25     |
|             |         |              |         |         |        |
| Dairy       |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 5       | 1            | 5       | 0.25    | 1.25   |
|             |         |              |         |         |        |
| Game Meat   |         |              |         |         |        |
| and Meat    |         |              |         |         |        |
| Products    |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 5       | 1            | 5       | 0.25    | 1.25   |
|             |         |              |         |         |        |
| Animal      |         |              |         |         |        |
| Casings     |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 3       | 1            | 3       | 0.25    | 0.75   |
|             |         |              |         |         |        |
| Gelatin     |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   | 3       | 1            | 3       | 0.25    | 0.75   |
|             |         |              |         |         |        |
| Collagen    |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+
| []{.mark}   |         |              |         |         | 31.5   |
|             |         |              |         |         |        |
| TOTAL       |         |              |         |         |        |
+-------------+---------+--------------+---------+---------+--------+

[]{.mark}

> []{.mark}

+------------+-----------+-----------+-----------+-----------+--------+
| Table 2    |           |           |           |           |        |
| Estimated  |           |           |           |           |        |
| Annual     |           |           |           |           |        |
| Reporting  |           |           |           |           |        |
| Burden     |           |           |           |           |        |
| (D         |           |           |           |           |        |
| isclosure) |           |           |           |           |        |
+============+===========+===========+===========+===========+========+
| []{.mark}  | No. of    | No. of    | Total     | Hours per | Total  |
|            | Re        | Responses | annual    | Response  | Hours  |
| Respondent | spondents | per       | Responses |           |        |
|            |           | R         |           |           |        |
|            |           | espondent |           |           |        |
+------------+-----------+-----------+-----------+-----------+--------+
| []{.mark}  | 15        | 1         | 15        | 8         | 120    |
|            |           |           |           |           |        |
| Trade      |           |           |           |           |        |
| A          |           |           |           |           |        |
| ssociation |           |           |           |           |        |
+------------+-----------+-----------+-----------+-----------+--------+
| []{.mark}  | 50        | 1         | 50        | 8         | 400    |
|            |           |           |           |           |        |
| State      |           |           |           |           |        |
+------------+-----------+-----------+-----------+-----------+--------+
| []{.mark}  |           |           |           |           | 520    |
|            |           |           |           |           |        |
| TOTAL      |           |           |           |           |        |
+------------+-----------+-----------+-----------+-----------+--------+

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

It is estimated that the annual burden would be no more than 31.5 hours.
The time to respond to the questions should take approximately 15
minutes using any of the technologies available to transmit the
information. All of the information asked for should be readily
available. The number of respondents is a rough estimate based on volume
of exports and responses received to date. For shell egg respondents, it
is approximated at 10 each. For game meat and game meat.

Full equivalency with EU directives has not been established to date,
therefore the additional assurance of compliance with the EU directives
is necessary to be able to continue trade with the EU countries. This
will necessitate additional hours for the producer to review the
directive this time is estimated at 20 minutes. Therefore the additional
time for compliance information is 42 hours (126 responses x 0.33
hours). This is included in the total burden hours.

[]{.mark}

The annual cost for firms to supply the information necessary to
maintain EC processor lists for shell eggs, dairy products, animal
casings, gelatin, collagen and game meat and game meat products is
estimated as follows:

[]{.mark}

Estimated total number of hours for response = 31.5

126 responses x 0.25 hours

Estimated cost of response time = \$895

hourly cost for response is estimated

as being equivalent to that of a base

GS-12 salary (\$28.41/hour)

If the trade associations desire to send out notification to their
members or publish in their trade magazine (third party disclosure),
this would potentially require an hour to add an article to a trade
magazine to approximately a day to print and send a notification to
their members for each trade association. The estimate of burden would
be approximately 120 hours. The number of associates would be 15 and the
total hours per association would be as high as 8 hours.

If state governments notify local processors, this would potentially
require an hour to add to a state bulletin or approximately a day to
notify processors by other means of communication. The maximum number of
states would be fifty and the total hours per state would be as high as
8 hours.

The annual third party disclosure costs for establishment of EC list is
estimated as follows:

Estimated total number of hours for disclosure = 520

15 trade associations and 50 states x 8 hours

Estimated cost of disclosure = \$14773

Hourly rate equivalent to the base GS-12 salary

13\. [Provide an estimate of the total annual cost burden, other than
hour burden, to respondents.]{.underline}

There are no additional costs.

14\. [Provide estimates of annualized cost to the Federal
government.]{.underline}

The cost to the Federal government would be that of reviewing the
information supplied by the firms/processors. This review would include
verification of inspection dates for each new firm, obtaining and
reviewing inspection reports. The five commodities area lists would be
modified and then transmitted to the EC. The lists would be reviewed for
any known additions or corrections on a quarterly basis. The annual cost
to the Federal government for maintenance is estimated as follows:

Estimated total hours per year = (126 x 2) = 252

estimated number of responses = 126

estimated number of hours for review = 2

[]{.mark}

Estimated total cost for establishment and review of lists

252 hours x \$34/ hour = \$8568

hourly costs is estimated as being equivalent to that of a base GS-13
salary

15\. [Explain the reasons for any program changes or
adjustments.]{.underline}

Since the renewal approval to obtain information for the maintenance and
updating of these lists an additional trade association has been
identified, the response from the shell egg and game meat products areas
were slightly less than anticipated and an additional commodity, gelatin
and collagen is being listed. In addition, since the list has been
established and companies do not need to reapply unless they have a
compliance problem, the only additions are those companies that are just
beginning trade with the EU. EU implementation dates for directives
governing trade with non EU countries are occurring with a trade
agreement in which full equivalency has not been determined, therefore
the products must be in compliance with the applicable requirements
which requires the processor to be aware of the EU requirements and to
acknowledge equivalent compliance.

16\. [Outline plans for tabulation and publication for collections of
information whose results will be published.]{.underline}

The lists will contain those firms/processors exporting to the EC which
comply with FDA regulations and which comply with EU directives.
Publication is handled by the EC according to their procedures.

17\. [Explain the reason that display of the expiration date for OMB
approval of the information would be inappropriate.]{.underline}

Not applicable

18\. [Explain each exception to the certification statement identified
in item 19.]{.underline}

Not applicable

B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

Not applicable