The European Community (EC) is a group
of 27 European countries that have agreed to harmonize their
commodity requirements to facilitate commerce among member States.
EC legislation for intra-EC trade has been extended to trade with
non-EC countries, including the United States. For certain food
products (e.g., shell eggs, dairy products, game meat, game meat
products, animal casings, and gelatin), EC legislation requires
assurances from the responsible authority of the country of origin
that the processor of the food is in compliance with applicable
regulatory requirements. FDA uses a list process to meet this
requirement. FDA requests information from processors that export
certain animal-derived products (e.g., shell eggs, dairy products,
game meat, game meat products, animal casings, and gelatin) to the
EC. FDA uses the information to maintain lists of processors that
have demonstrated current compliance with U.S. requirements and
provides the lists to the EC quarterly. Inclusion on the list is
voluntary. EC member countries refer to the lists at ports of entry
to verify that products offered for importation to the EC from the
United States are from processors that meet U.S. regulatory
requirements. Products processed by firms not on the lists are
subject to detention and possible refusal at the port. Through this
process, FDA is implementing the general policy-making authority
granted the Commissioner under 21 U.S.C. 393(d)(2).
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.