[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)]
[Notices]
[Pages 46744-46746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Memorandum of Understanding Between the Food and Drug 
Administration and the Department of Agriculture, Food and Forestry of 
Ireland

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and the Department of 
Agriculture, Food and Forestry of Ireland. The purpose of the MOU is to 
establish certification requirements for caseins, caseinates, and 
mixtures thereof.

DATES: The agreement became effective November 5, 1996.

FOR FURTHER INFORMATION CONTACT: Merton Smith, Office of Health Affairs 
(HFY-50), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOU's between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.


[[Page 46745]]


    Dated: August 28, 1997.
William B. Schultz,
Deputy Commissioner for Policy.

Memorandum of Understanding Between the Food and Drug Administration 
Department of Health and Human Services of the United States of America 
and the Department of Agriculture, Food and Forestry of Ireland 
Covering Caseins, Caseinates, and Mixtures Thereof Exported to the 
United States

I. Purpose

    The Food and Drug Administration (FDA), Department of Health and 
Human Services of the United States of America and the Department of 
Agriculture, Food and Forestry (DAFF) of Ireland upon signing this 
Memorandum of Understanding (MOU) intend to:
    1. Establish certification requirements for the caseins, 
caseinates, and mixtures thereof exported from Ireland to the United 
States to assure that contaminated caseins, caseinates, and mixtures 
thereof will not be imported into the United States.
    2. Minimize the need for extensive FDA audit sampling of these 
certified products from Ireland.

II. Definitions

    For the purposes of this MOU, both participants concur in the 
following definitions:
    LOT: A lot is a quantity of casein, caseinates, or mixtures 
thereof packaged by one manufacturer during a definite period of 
time not exceeding one (1) day. The manufacturing process, including 
milling and packaging, is performed by using a perfectly identified 
processing line. Caseins, caseinates, or mixtures thereof intended 
for export to the United States are packaged, after milling, in 
identical containers identified by a unique code or mark traceable 
to the manufacturer.
    SALMONELLA-NEGATIVE: The absence of Salmonella in thirty (30) 
subsamples, each of twenty-five (25) grams, that have been taken 
from the same lot of product and tested using the procedures 
contained in the current edition of the Bacteriological Analytical 
Manual (see Section V. Analytical Methodology).
    PHOSPHATASE-NEGATIVE: The absence of phosphatase activity in 
thirty (30) subsamples, each of twenty-five (25) grams, that have 
been taken from the same lot of product and tested using the method 
contained in the current edition of the Official Methods of Analysis 
(see Section V. Analytical Methodology).

III. Substance of MOU

    A. The Department of Agriculture, Food and Forestry of Ireland
    The Department of Agriculture, Food and Forestry of Ireland 
(DAFF) is the agency of the Irish government responsible for 
inspecting those caseins, caseinates, and mixtures thereof that are 
intended for export. Such inspection is necessary for consumer 
protection. To fulfill its responsibilities under this Memorandum of 
Understanding, DAFF intends to ensure that caseins, caseinates, and 
mixtures thereof that are intended for export to the United States 
are fit for human consumption in that they comply with the 
requirements of the Food, Drug, and Cosmetic Act of the United 
States, of the Public Health Service Act of the United States, and 
of this Memorandum of Understanding. DAFF intends to inspect and 
analyze samples of these caseins, caseinates, and mixtures thereof 
to ensure that they comply with these requirements.
    To discharge its responsibilities regarding caseins, caseinates, 
and mixtures thereof and to fulfill its commitment under this MOU, 
DAFF plans to:
    1. Inspect and analyze each lot of caseins, caseinates, and 
mixtures thereof produced in Ireland for export to the United States 
to assure that it is Salmonella-negative and phosphatase-negative, 
based on the testing of thirty (30) subsamples of twenty-five (25) 
gram units taken from bags in a lot of caseins, caseinates, and 
mixtures thereof immediately before closing, as determined by the 
methods cited in Section V. Analytical Methodology.
    2. Require that all containers of a lot of caseins, caseinates, 
and mixtures thereof that are to be exported to the United States be 
certified as comply with the provisions of this Memorandum of 
Understanding, and identified by a lot number, and all other 
information required by the Federal Food, Drug, and Cosmetic Act of 
the United States.
    3. Require that all of the information that is required by the 
Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act 
of the United States be included on the label and labeling of 
individual products.
    4. Furnish FDA with a copy of the current Irish regulations and 
the procedures used to ensure that the caseins, caseinates, and 
mixtures thereof are in compliance with those regulations and with 
the Food, Drug, and Cosmetic Act and the Public Health Service Act 
of the United States.
    5. Furnish FDA, upon request, with a full description of the 
manufacturing processes and quality controls used to ensure that the 
caseins, caseinates, and mixtures thereof that are produced are fit 
for human consumption, as discussed in III. A. Substance of MOU.
    B. The Food and Drug Administration of the United States of 
America
    FDA is charged with the enforcement of the Food, Drug, and 
Cosmetic Act, the Fair Packaging and Labeling Act, certain 
provisions of the Public Health Service Act, and other related 
statutes of the United States. FDA directs its activities toward the 
protection of the public health in the United States by ensuring 
that foods are safe and wholesome and are honestly and informatively 
labeled. FDA accomplishes this goal in part through inspections of 
food processors and distributors. In addition, it collects and 
examines samples to ensure compliance with these statutes. FDA makes 
a concerted effort to ensure that foods entering the United States 
meet the same standards as domestic products. To discharge these 
responsibilities regarding caseins, caseinates, and mixtures thereof 
and to fulfill this Memorandum of Understanding, FDA plans to:
    1. Audit samples of caseins, caseinates, and mixtures thereof 
certified by DAFF under this Memorandum of Understanding to ensure 
that the products exported from Ireland and offered for import into 
the United States comply with the requirements of the Food, Drug, 
and Cosmetic Act, the Fair Packaging and Labeling Act, the Public 
Health Service Act, and other related statutes of the United States.
    2. Share any information obtained through its audit sampling 
with DAFF and the First Secretary of the Embassy of Ireland.
    3. Promptly notify DAFF and the First Secretary of the Embassy 
of Ireland of the detention of any caseins, caseinates, and mixtures 
thereof covered by this Memorandum of Understanding.
    4. Share expertise and provide consultative assistance to DAFF 
when necessary to assure the safety of the caseins, caseinates, and 
mixtures thereof exported to the United States.

IV. Sample Collection

    The same samples should be used to determine both the presence, 
if any, of Salmonella and the level of phosphatase activity.
    Each sample will consist of thirty (30) subsamples of caseins, 
caseinates, or mixtures thereof. Each subsample will consist of 
approximately twenty-five (25) grams that will be collected in 
accordance with the applicable portions of the current edition of 
the Bacteriological Analytical Manual (see Section V. Analytical 
Methodology).

V. Analytical Methodology

    Compliance with the established criteria for Salmonella and 
phosphatase should be determined according to the methods contained 
in the current editions of Bacteriological Analytical Manual for 
Salmonella and Official Methods of Analysis for phosphatase.
    These publications are available from:
AOAC International
481 North Frederick Avenue, Suite 500
Gaithersburg, MD 20877
Telephone number: 301-924-7077
Telefax number: 301-924-7089

VI. Participating Parties

A. The Department of Agriculture, Food and Forestry, Agriculture 
House, Kildare Street, Dublin 2, Ireland
B. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, USA

VII. Liaison Officers

A. For the Department of Agriculture, Food and Forestry: Principal 
Officer, Milk Policy Division, (Currently, Mr. Tom Moran), 
Department of Agriculture, Food and Forestry, Agriculture House, 
Kildare Street, Dublin 2, Ireland
For the Embassy of Ireland: First Secretary, (Currently, Ms. Kate 
Slattery), 2234 Massachusetts Avenue, N.W., Washington,

[[Page 46746]]

DC 20008. Telephone number: 202-452-3939
B. For the Food and Drug Administration: Director, International 
Activities Staff, (Currently, Mr. Charles W. Cooper), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 
C Street, S.W., Washington, DC 20204. Telephone number: 202-205-
5042, Telefax number: 202- 205-0165

VIII. Administrative Procedures

    The participants mutually consent on the ways and means of 
giving instructions and guidance for the practical implementation 
and application of this Memorandum of Understanding.
    The obligations under this MOU are intended to be non-binding.

IX. Period of MOU

    Activities under this Memorandum of Understanding commence upon 
signature by both participants for a period of five (5) years and 
may, at the conclusion of that period, with the consent of both 
participants, be extended for an additional five (5) years. The 
participants plan to evaluate the MOU sometime during each five (5) 
year period. The MOU may be extended or revised by mutual consent, 
or terminated by either participant, upon a thirty (30) day advance 
written notice to the other.

    For the Department of Agriculture, Food and Forestry of Ireland
By: K. Slattery
Title: First Secretary, Embassy of Ireland
Date: November 5, 1996
Place: Rockville, Maryland
    For the Food and Drug Administration, Department of Health and 
Human Services of the United States of America
By: M. A. Friedman
Title: Deputy Commissioner for Operations, U.S. Food and Drug 
Administration
Date: November 5, 1996
Place: Rockville, Maryland
[FR Doc. 97-23451 Filed 9-3-97; 8:45 am]
BILLING CODE 4160-01-F