[Federal Register Volume 62, Number 234 (Friday, December 5, 1997)]
[Notices]
[Pages 64387-64391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31809]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0442]
Memoranda of Understanding Between the Food and Drug
Administration and the United States Department of Agriculture
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the United States
Department of Agriculture (USDA) have revised three memoranda of
understanding (MOU's) with regard to control of aflatoxin in peanuts,
in-shell Brazil nuts, and in-shell pistachio nuts. The purpose of the
MOU's is to set forth the responsibility for aflatoxin testing of
domestic and imported raw peanuts, imported in-shell Brazil nuts, and
imported in-shell pistachio nuts.
DATES: The MOU's became effective October 1, 1997.
FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-260-0631.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOU's signed by FDA and other
departments, agencies, and organizations shall be published in the
Federal Register, the agency is publishing three revised MOU's between
FDA and USDA that set forth the responsibility for aflatoxin testing of
domestic and imported raw peanuts, imported in-shell Brazil nuts, and
imported in-shell pistachio nuts.
Dated: November 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
The text of the three MOU's follows:
Agreement No.
[[Page 64388]]
225-96-2001
Revision 1
12-25-MU-335
Revision 1
Memorandum of Understanding Between the Science and Technology Division
of the Agricultural Marketing Service, United States Department of
Agriculture and the Food and Drug Administration, Department of Health
and Human Services
PROJECT..................................... Aflatoxin testing of
domestic and imported
peanuts
LEADERS..................................... Administrator,
Agricultural Marketing
Service (AMS), United
States Department of
Agriculture (USDA) and
Associate Commissioner
for Regulatory Affairs,
Food and Drug
Administration (FDA),
Department of Health and
Human Services (HHS)
LOCATIONS................................... Albany, Ashburn, Blakely,
Camilla, and Dawson,
Georgia, Dothan, Alabama,
Aulander, North Carolina,
Madill, Oklahoma, and
Suffolk, Virginia
HEADQUARTERS................................ Washington, DC
EFFECTIVE DATE.............................. October 1, 1997
LEGAL AUTHORITY............................. The Agricultural Marketing
Act of 1946, and the
Federal Food, Drug, and
Cosmetic Act of 1938, as
Amended
REVISION.................................... This is a revision of and
shall supersede
Memorandum of
Understanding, FDA-225-96-
2001, effective October
1, 1995, between FDA and
AMS.
ORGANIZATION................................ The organization shall
consist of the leaders,
qualified analytical
chemists and physical
science technicians
provided and supervised
by the AMS Aflatoxin
Supervisor, and technical
contacts provided and
supervised by the Chief,
Technical Services
Branch, Science and
Technology Division
(S&TD), AMS.
BACKGROUND.................................. Aflatoxins are toxic
metabolites produced by
the molds Aspergillus
flavus and Aspergillus
parasiticus. If present
in sufficient amounts,
they may cause acute
toxicity and are known to
be carcinogens for some
animals. Peanuts, tree
nuts, corn, and other
small grains are
susceptible to aflatoxin
contamination. The Peanut
Administrative Committee
(PAC) administers
Marketing Agreement 146
with USDA oversight to
control the aflatoxin
problem in peanuts and
ensure the wholesomeness
of peanuts moving into
channels for human
consumption. The Peanut
Marketing Agreement
requirement for domestic
edible peanuts is 15
parts per billion (ppb)
total aflatoxins or less.
Imported peanuts must
meet the same requirement
as domestic peanuts, and
importers of peanuts must
offer each lot of the
product to USDA or a PAC-
approved laboratory for
inspection before
introducing that lot into
United States commerce.
RESPONSIBILITIES:
AMS intends to:
1. Continue to provide oversight to the PAC in the
administration of the Marketing Agreement for peanuts to control the
incidence and levels of total aflatoxins in domestically produced
peanuts.
2. Monitor and inspect imported raw peanuts upon effective date
of peanut import regulations.
3. Perform all aflatoxin assays using the official methods in
the current ``Instruction Manual for Aflatoxin Testing'', United
States Department of Agriculture, Agricultural Marketing Service,
Science and Technology Division, Technical Services Branch.
4. Issue aflatoxin certificates as (1) ``negative'' if the level
is not over 15 ppb; (2) number if the level is over 15 ppb.
5. Provide FDA with a copy of the certificate of total
aflatoxins analysis and the name of the applicant on each lot, both
domestic and imported, found to exceed 15 ppb total aflatoxins and
the analysis certificate on any lot on request.
FDA Intends to:
1. Maintain its administrative guideline at 20 ppb on objective
samples recognizing that good manufacturing practices remove
significant quantities of unfit peanuts and that levels of total
aflatoxins are reduced by heating.
2. Not object to the offering of lots of peanuts to processors
where certificates show levels of total aflatoxins above 25 ppb but
to examine routinely finished products from such lots. Such lots of
raw peanuts may be subject to action in cases where there is not a
reasonable assurance that the finished product will contain no more
than 20 ppb total aflatoxins.
AMS and FDA mutually agree to:
1. Designate a person to serve as a central contact to whom
communications dealing with this agreement or matters affected
thereby may be first referred for attention.
For the Food and Drug Administration: Director, Division of
Programs and Enforcement Policy, HFS-305 (currently Terry C.
Troxell, Ph.D.) Office of Plant and Dairy Foods and Beverages Center
for Food Safety and Applied Nutrition, 200 C. Street S.W.,
Washington, D.C. 20204, Telephone: 202-205-5321
For the Agricultural Marketing Service: Director, Science and
Technology Division (currently William J. Franks, Jr.) USDA, AMS
14th & Independence Avenue, S.W. Washington, D.C. 20090-6456,
Telephone: 202-720-6496.
2. Maintain close working relations with each other, both in
headquarters as well as in the field.
3. Work with industry toward greater efficiency in connection
with improvement of the testing program.
BASIS OF COOPERATION--This Memorandum of Understanding defines
in general terms the basis on which the parties concerned will
cooperate, and does not constitute a financial obligation to serve
as a basis for expenditures. Each party will handle and expend its
own funds. Any and all expenditures from Federal funds in the
Department of Agriculture made in conformity with the plans outlined
in the Memorandum of Understanding must be in accord with Department
rules and regulations and in each instance based upon appropriate
finance papers. Expenditures made by FDA will be in accord with its
rules and regulations.
Nothing in this agreement modifies other existing agreements,
nor does it preclude entering into separate agreements setting forth
procedures for special programs that can be handled more efficiently
and expeditiously by such special agreement.
The responsibilities assumed by the cooperating parties under
this Memorandum of Understanding are contingent upon funds being
available from which expenditures legally may be made.
DURATION--This agreement will continue in force indefinitely. It
may be amended or terminated by mutual consent of the parties in
writing. It may be terminated by either party upon 30 days' notice
in writing to the other party.
This agreement is hereby approved for the Agricultural Marketing
Service.
[[Page 64389]]
Done at Washington, D.C. on October 1, 1997,
Barbara A. Chaffey,
Deputy Administrator, Marketing Programs Agricultural Marketing
Service.
This agreement is hereby approved for the Food and Drug
Administration:
Done at Washington, D.C. on October 1, 1997,
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
Agreement No.
225-96-2002
Revision 1
12-25-MU-334
Revision 1
Memorandum of Understanding Between the Science and Technology Division
of the Agricultural Marketing Service, United States Department of
Agriculture and the Food and Drug Administration, Department of Health
and Human Service
PROJECT..................................... Voluntary aflatoxin
testing of imported in-
shell Brazil nuts
LEADERS..................................... Administrator,
Agricultural Marketing
Service (AMS), United
States Department of
Agriculture (USDA) and
Associate Commissioner
for Regulatory Affairs,
Food and Drug
Administration (FDA),
Department of Health and
Human Services (HHS)
LOCATIONS................................... Blakely, Georgia, and
Dothan, Alabama
HEADQUARTERS................................ Washington, DC
EFFECTIVE DATE.............................. October 1, 1997
LEGAL AUTHORITY............................. The Agricultural Marketing
Act of 1946, and the
Federal Food, Drug, and
Cosmetic Act of 1938, as
Amended
REVISION.................................... This is a revision of and
shall supersede
Memorandum of
Understanding, FDA-225-96-
2002, effective October
1, 1995, between FDA and
AMS.
ORGANIZATION................................ The organization shall
consist of the leaders,
qualified analytical
chemists and physical
science technicians
provided and supervised
by the AMS Aflatoxin
Supervisor, and technical
contacts provided and
supervised by the Chief,
Technical Services
Branch, Science and
Technology Division
(S&TD), AMS.
BACKGROUND.................................. Aflatoxins have been shown
to cause cancer in
certain laboratory
animals. Aflatoxins are
produced by the mold
Aspergillus flavus and
may contaminate various
kinds of foods, including
Brazil nuts. FDA and AMS
have cooperated with
United States importers
in a program for sampling
and aflatoxin testing of
imported Brazil nuts.
Neither AMS nor FDA has a
formal agreement with the
Brazil nut importers.
Under this voluntary
program, importers of
Brazil nuts offer each
lot of the product to
USDA for inspection prior
to its introduction into
United States commerce.
USDA is responsible for
sampling and testing each
lot for total aflatoxins
in accordance with
procedures prescribed by
FDA and for issuing an
analysis certificate for
each lot tested.
RESPONSIBILITIES:
AMS intends to:
1. Draw samples in accordance with the following schedule:
Table I.--Lots Packed in Containers Weighing 50 lbs. or Less
------------------------------------------------------------------------
Number of bags Total pounds Approximate
Number of bags in lot sampled in sample no. of nuts
------------------------------------------------------------------------
500 or less 60 20 1,000
501-1,800 120 40 2,000
1,801-4,500 180 60 3,000
------------------------------------------------------------------------
Table II.--Lots packed in containers weighing 51 to 120 lbs.
------------------------------------------------------------------------
Number of bags Total pounds Approximate
Number of bags in lot sampled in sample no. of nuts
------------------------------------------------------------------------
200 or less 20 20 1,000
201-800 40 40 2,000
801-2,000 60 60 3,000
------------------------------------------------------------------------
2. Perform aflatoxin assay.
(a) Shell and Kernel Analysis.
The entire sample of shells and kernels will be ground in a
vertical cutter mixer. A well-mixed portion of the ground composite
will be assayed chemically for total aflatoxins, using the BF method
as described in the book of Official Methods of Analysis of AOAC
International, 16th ed., Vol. II, Sec. 49.2.09. The total aflatoxins
level will be calculated on the basis of the nut kernel, assuming
the kernel constitutes half the weight of the total in-shell nut.
(b) Kernel Analysis
The entire sample is individually shelled. Those kernels that
have an obviously inedible appearance will be discarded. The
remaining kernels will be composited and ground with the addition of
an inert grinding aid. A well-mixed portion of the ground composite
will be assayed as described in paragraph (a) above.
3. Report Results
(a) A separate analysis certificate will be issued for each lot.
Appropriate identification marks will be shown on each certificate
so that the report can be related to the specific lot sampled.
(b) Provide appropriate FDA District Office the results of
aflatoxin analysis for lots that may be subject to action under the
Food, Drug, and Cosmetic Act and
[[Page 64390]]
analysis certificate on any lot upon request.
FDA intends to:
1. Notify AMS of the criteria FDA will use concerning total
aflatoxins levels in lots to determine whether they may be subject
to action under the Food, Drug, and Cosmetic Act.
2. Review results of aflatoxin analysis for lots provided by AMS
to determine whether they may be subject to action under the Food,
Drug, and Cosmetic Act.
AMS and FDA mutually agree to:
1. Designate a person to serve as a central contact to whom
communications dealing with this agreement or matters affected
thereby may be first referred for attention.
For the Food and Drug Administration: Director, Division of
Programs and Enforcement Policy, HFS-305 (currently Terry C.
Troxell, Ph.D.), Office of Plant and Dairy Foods and Beverages,
Center for Food Safety and Applied Nutrition, 200 C. Street S.W.
Washington, D.C. 20204, Telephone: 202-205-5321
For the Agricultural Marketing Service: Director, Science and
Technology Division (currently William J. Franks, Jr.) USDA, AMS
14th & Independence Avenue, S.W. Washington, D.C. 20090-6456,
Telephone: 202-720-6496.
2. Maintain close working relations with each other, both in
headquarters as well as in the field.
3. Work with industry toward greater efficiency in connection
with improvement of the testing program.
BASIS OF COOPERATION--This Memorandum of Understanding defines
in general terms the basis on which the parties concerned will
cooperate, and does not constitute a financial obligation to serve
as a basis for expenditures. Each party will handle and expend its
own funds. Any and all expenditures from Federal funds in the
Department of Agriculture made in conformity with the plans outlined
in the Memorandum of Understanding must be in accord with Department
rules and regulations and in each instance based upon appropriate
finance papers. Expenditures made by FDA will be in accord with its
rules and regulations.
Nothing in this agreement modifies other existing agreements,
nor does it preclude entering into separate agreements setting forth
procedures for special programs that can be handled more efficiently
and expeditiously by such special agreement.
The responsibilities assumed by the cooperating parties under
this Memorandum of Understanding are contingent upon funds being
available from which expenditures legally may be made.
DURATION--This agreement will continue in force indefinitely. It
may be amended or terminated by mutual consent of the parties in
writing. It may be terminated by either party upon 30 days' notice
in writing to the other party.
This agreement is hereby approved for the Agricultural Marketing
Service.
Done at Washington, D.C. on October 1, 1997,
Barbara A. Chaffey,
Deputy Administrator, Marketing Programs Agricultural Marketing
Service.
This agreement is hereby approved for the Food and Drug
Administration:
Done at Washington, D.C. on October 1, 1997,
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
Agreement No.
225-96-2003
Revision 1
12-25-MU-336
Revision 1
Memorandum of Understanding between the Science and Technology Division
of the Agricultural Marketing Service, United States Department of
Agriculture and the Food and Drug Administration Department of Health
and Human Services
PROJECT..................................... Voluntary aflatoxin
testing of imported in-
shell pistachio nuts
LEADERS..................................... Administrator,
Agricultural Marketing
Service (AMS), United
States Department of
Agriculture (USDA) and
Associate Commissioner
for Regulatory Affairs,
Food and Drug
Administration (FDA),
Department of Health and
Human Services (HHS)
LOCATIONS................................... Blakely, Georgia, and
Dothan, Alabama
HEADQUARTERS................................ Washington, DC
EFFECTIVE DATE.............................. October 1, 1997
LEGAL AUTHORITY............................. The Agricultural Marketing
Act of 1946, and the
Federal Food, Drug, and
Cosmetic Act of 1938, as
Amended
REVISION.................................... This is a revision of and
shall supersede
Memorandum of
Understanding, FDA 225-96-
2003, effective October
1, 1995, between FDA and
AMS.
ORGANIZATION................................ The organization shall
consist of the leaders,
qualified analytical
chemists and physical
science technicians
provided and supervised
by the AMS Aflatoxin
Supervisor, and technical
contacts provided and
supervised by the Chief,
Technical Services
Branch, Science and
Technology Division
(S&TD), AMS.
BACKGROUND.................................. Aflatoxins have been shown
to cause cancer in
certain laboratory
animals. Aflatoxins are
produced by the mold
Aspergillus flavus and
may contaminate various
kinds of foods, including
pistachio nuts. FDA and
AMS have cooperated with
United States importers
in a program for sampling
and aflatoxin testing of
imported pistachio nuts.
Neither AMS nor FDA has a
formal agreement with the
pistachio nut importers.
The program is conducted
on a voluntary basis
whereby importers of
pistachio nuts offer each
lot of the product to
USDA for inspection
before introducing that
lot into United States
commerce. USDA is
responsible for sampling
and testing each lot for
total aflatoxins in
accordance with
procedures prescribed by
FDA and for issuing an
analysis certificate for
each lot tested.
RESPONSIBILITIES:
AMS intends to:
1. Draw samples in accordance with the following schedule:
Table I.
------------------------------------------------------------------------
Percent of containers
Total weight of lot sampled Total sample weight
------------------------------------------------------------------------
75,000 lb or less Minimum of 20% Shelled-25 lb In-
shell-50 lb
More than 75,000 lb to Minimum of 20% Shelled-50 lb In-
150,000 lb shell-100lb
------------------------------------------------------------------------
[[Page 64391]]
For lots with total weight greater than 150,000 pounds, a sample
will be selected from 20 percent of the containers in the lot and
consist of 25 lb of shelled nuts or 50 lb of in-shell nuts for each
multiple of 75,000 lb (e.g., 150,000 to 225,000 lb requires a 3-fold
sample of 75 lb shelled or 150 lb of in-shell nuts).
2. Perform aflatoxin assay.
(a) In-Shell Lots.
The entire sample of shells and kernels will be ground in a
vertical cutter mixer. A well-mixed portion of the ground composite
will be assayed chemically for total aflatoxins, using either of the
two methods for aflatoxin assay in pistachios described in the book
of Official Methods of Analysis of AOAC International, 16th ed.,
Vol. II, Sec. 49.2.23. The aflatoxin level will be calculated on a
kernel weight basis.
(b) Shelled Lots
The entire sample shall be ground, including those kernels which
have an obvious inedible appearance. A well-mixed portion of the
ground composite will be assayed as in paragraph 2.(a) above.
3. Report Results
(a) A separate analysis certificate will be issued for each lot.
Appropriate identification marks will be shown on each certificate
so that the report can be related to the specific lot sampled.
(b) Provide appropriate FDA District Office the results of
aflatoxin analysis for lots that may be subject to action under the
Food, Drug, and Cosmetic Act and analysis certificate on any lot
upon request.
FDA intends to:
1. Notify AMS of the criteria FDA will use concerning total
aflatoxins levels in lots to determine whether they may be subject
to action under the Food, Drug, and Cosmetic Act.
2. Review results of aflatoxin analysis for lots provided by AMS
to determine whether they may be subject to action under the Food,
Drug, and Cosmetic Act.
AMS and FDA mutually agree to:
1. Designate a person to serve as a central contact to whom
communications dealing with this agreement or matters affected
thereby may be first referred for attention.
For the Food and Drug Administration: Director, Division of
Programs and Enforcement Policy, HFS-305 (currently Terry C.
Troxell, Ph.D.) Office of Plant and Dairy Foods and Beverages,
Center for Food Safety and Applied Nutrition 200 C. Street S.W.
Washington, D.C. 20204 Telephone: 202-205-5321
For the Agricultural Marketing Service: Director, Science and
Technology Division (currently William J. Franks, Jr.) USDA, AMS
14th & Independence Avenue, S.W. Washington, D.C. 20090-6456,
Telephone: 202-720-6496.
2. Maintain close working relations with each other, both in
headquarters as well as in the field.
3. Work with industry toward greater efficiency in connection
with improvement of the testing program.
BASIS OF COOPERATION--This Memorandum of Understanding defines
in general terms the basis on which the parties concerned will
cooperate, and does not constitute a financial obligation to serve
as a basis for expenditures. Each party will handle and expend its
own funds. Any and all expenditures from Federal funds in the
Department of Agriculture made in conformity with the plans outlined
in the Memorandum of Understanding must be in accord with Department
rules and regulations and in each instance based upon appropriate
finance papers. Expenditures made by FDA will be in accord with its
rules and regulations.
Nothing in this agreement modifies other existing agreements,
nor does it preclude entering into separate agreements setting forth
procedures for special programs that can be handled more efficiently
and expeditiously by such special agreement.
The responsibilities assumed by the cooperating parties under
this Memorandum of Understanding are contingent upon funds being
available from which expenditures legally may be made.
DURATION--This agreement will continue in force indefinitely. It
may be amended or terminated by mutual consent of the parties in
writing. It may be terminated by either party upon 30 days' notice
in writing to the other party.
This agreement is hereby approved for the Agricultural Marketing
Service.
Done at Washington, D.C. on October 1, 1997,
Barbara A. Chaffey,
Deputy Administrator, Marketing Programs Agricultural Marketing
Service.
This agreement is hereby approved for the Food and Drug
Administration:
Done at Washington, D.C. on October 1, 1997,
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 97-31809 Filed 12-4-97; 8:45 am]
BILLING CODE 4160-01-F
