[Federal Register Volume 61, Number 66 (Thursday, April 4, 1996)]
[Notices]
[Pages 15077-15079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8360]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0089]


Establishment of Lists of U.S. Firms/Processors Exporting Shell 
Eggs, Dairy Products, Game Meat and Game Meat Products to the European 
Community; Request for Information From Such Firms

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to establish lists of U.S. firms/processors exporting shell 
eggs, dairy products, game meat and game meat products to the European 
Community (EC) that manufacture products in compliance with U.S. food 
laws and regulations. FDA is taking this action in response to current 
changes in the EC legislation that will require countries trading with 
any of the EC member countries to provide lists of firms exporting 
certain animal derived commodities to the EC. FDA is requesting that 
U.S. firms presently exporting, or who anticipate exporting these 
commodities to the EC, provide the agency with information for 
inclusion on the appropriate list. This list will be updated on a 
quarterly basis and will be submitted to the EC. This notice is 
intended to alert all U.S. exporters to the EC requirement for lists of 
companies processing animal derived commodities that are exported to 
the EC member states. The agency is also requesting comments on the 
best mechanisms to be used in obtaining future changes and additions to 
the EC lists for these commodities.

DATES: Written comments and information for inclusion on the EC list by 
April 30, 1996. Written comments on the information collection 
requirements by May 6, 1996.

ADDRESSES: Submit written information for inclusion on the EC list to 
Marilyn F. Balmer, Center for Food Safety and Applied Nutrition (HFS-
306), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, FAX 202-205-4422 or E-mail [email protected].
    Submit written comments on the best mechanisms to be used in 
obtaining future changes and additions to the EC lists for dairy 
products, shell eggs, game meat and game meat products to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should be 
identified with the Docket number found in brackets in the heading of 
this document.
    Submit written comments on the information collection requirements 
to DHHS Reports Clearance Officer, Paperwork Reduction Project (0910-
0320), Hubert Humphrey Bldg., 200 Independence Ave. SW., rm. 531-H, 
Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Marilyn F. Balmer, Center for Food

[[Page 15078]]
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4400.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The EC is a group of 15 European countries that have agreed to 
harmonize their commodity requirements to facilitate commerce among the 
member states. Those countries which are members of the EC are as 
follows: United Kingdom, France, Italy, Spain, Portugal, Germany, 
Netherlands, Belgium, Denmark, Luxembourg, Ireland, Greece, Austria, 
Finland, and Sweden.
    Lists of processors (businesses) and the use of public and/or 
animal health certificates are an integral part of EC legislation 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 that must be followed by the member states for 
intracommunity trade in commodities. Member states of the EC are 
required by EC legislation to maintain lists of processing firms which 
meet these EC directives. The lists of processors approved by member 
states are published in the Official Journal of the European Community. 
Public and/or animal health certificates issued by the government of 
the country of origin are required to accompany every shipment of these 
products. For animal derived commodities, these directives were 
developed with regard to animal and public health considerations. Dates 
are being established at which time importation of commodities from 
third countries (i.e., the United States and other non-EC countries) 
will be subject to the minimum requirements of these directives. The 
Department of Agriculture and FDA are presently negotiating with the EC 
with a view to establishing agreement on the comparability of U.S. and 
EC regulatory systems to ensure that commodities trade with the EC is 
not disrupted. The EC directives on shell eggs, dairy products, game 
meat and game meat products are as follows:
    1. EC Council Directive 92/46/EEC contains the rules for the 
production and sale of raw milk, heat-treated milk and milk-based 
products. In chapter III, article 23 of this directive, for importation 
into the EC from third countries, lists and certificates are required. 
The list identifies the establishments which meet the EC requirements 
and the certificates are health certificates (animal and public).
    2. EC Council Directive 92/45/EEC contains the rules for slaughter 
and sale of wild-game meat. In chapter III, articles 16 and 17 of this 
directive, for importation into the EC from third countries (non-EC) 
lists and certificates are required. The list identifies establishments 
which meet EC requirements and the certificates are both public and 
animal health certificates.
    3. EC Council Directive 91/495/EEC contains the rules for the 
production, slaughter, and sale of rabbit meat and farmed-game meat. EC 
Council Directive 92/118/EEC, annex 1, chapter 11 requires that for 
imported rabbit meat and farmed game meat that animal and public health 
certificates be provided and that chapters II and III from Directive 
91/495/EEC be followed. Directive 91/495/EEC requires lists of 
establishments which meet the requirements.
    4. EC Council Directive 92/5/EEC contains the rules for the 
production and marketing of meat products including those derived from 
game meats. EC Council Directive 92/118/EEC, annex II, chapter 1 
requires that imported meat products have a public health certificate 
and that rules from Directive 77/99/EEC, which was amended by Directive 
92/5/EEC be followed. Within these directives lists of establishments 
are required. Meat products are those prepared from or with meat which 
has undergone treatment such that the cut surface no longer has the 
characteristics of fresh meat.
    5. EC Council Directive 94/65/EC contains the rules for production 
and marketing of meat preparations. Meat preparations include those 
products derived from game meat. The EC directive further distinguishes 
these products by specifying that the cut surface of the meat 
preparations has not lost the characteristics of fresh meat. In chapter 
V, article 13, certificates and lists are required for importation of 
these products from third countries (non-EC).
    6. EC Council Decision 94/371/EEC, Council Regulation EEC N 1907 
and Commission Regulation EEC N 1274/91 contains the rules for the 
production and marketing of shell eggs. Council Directive 92/118 lays 
down the animal and public health requirements for trade and imports 
not subject to specific EC rules. Within these directives lists and 
certificates are required.
    Shell eggs, hard cooked eggs and imitation egg products; dairy 
products; and game meats and game meat products (i.e., non-FSIS 
mandatorily inspected meat and poultry) are commodities for which the 
FDA is the Federal agency responsible for public health protection. 
Other governmental agencies such as Agriculture Marketing Service and 
Food Safety Inspection Service offer voluntary inspection of these 
commodities.

II. Intention to Establish Lists of U.S. Firms/Processors

    Initially, FDA intends to establish lists of U.S. firms/processors 
that meet U.S. regulations and export to the EC the following products: 
Shell egg, dairy products and game meat commodities. Inclusion of U.S. 
firms/processors on these lists is voluntary. However, commodities from 
firms not on these lists could be detained at the EC port of entry. In 
the past, seafood shipments from firms not on the seafood list were 
detained and not allowed into the EC. FDA officials accompanied by EC 
officials may visit any firm placed on these lists for auditing of the 
U.S. public and animal health systems.
    U.S. firms/processors that export the previously mentioned products 
to the EC and want to be included in the appropriate lists that the 
agency is developing should submit the following information to FDA to 
Marilyn F. Balmer (address above):
    1. Business name and address;
    2. Name and telephone number of contact person;
    3. List of products presently shipped to EC and those intended to 
be shipped in the next 2 years;
    4. Name and address of the manufacturing plant for each product;
    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.
    The mechanism for updating and maintaining these lists is being 
reviewed. Comments on methods for maintenance are welcome.
    FDA is presently considering procedures for certificates and will 
notify exporters in an appropriate manner.

III. Paperwork Reduction Act

    OMB has approved this collection of information under the emergency 
processing provision of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(j)) and has assigned OMB control number 0910-0320. Public 
reporting burden for this voluntary collection of information is 
estimated to average 0.25 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and

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completing the collection of information. Send comments regarding this 
burden estimate or any other aspects of this collection of information, 
including suggestions for reducing the burden, to: DHHS Reports 
Clearance Officer, Paperwork Reduction Project (0910-0320), Hubert 
Humphrey Bldg., 200 Independence Ave. SW., rm 531-H, Washington, DC 
20201. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a current valid OMB control number.
    Submit written information for inclusion on the EC list to Marilyn 
F. Balmer (address above).
    Submit written comments on the best mechanisms to be used in 
obtaining future changes and additions to the EC lists for dairy 
products, shell eggs, game meat and game meat products to the Dockets 
Management Branch (address above). All comments should be identified 
with the docket number found in the brackets in the heading of this 
document.

    Dated: March 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8360 Filed 4-1-96; 3:24 pm]
BILLING CODE 4160-01-F