0320 EU Dairy List Federal Register Notice

[Federal Register: April 4, 1996 (Volume 61, Number 66)]

[Notices]

[Page 15077-15079]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04ap96-90]

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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

[[Page 15079]]

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