About FDA
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MOU 225-11-0008
MEMORANDUM OF UNDERSTANDING
Between the
The Science and Technology Program of
The Agricultural Marketing Service
United States Department of Agriculture
and
The Food and Drug Administration
Department of Health and Human Services
PART I, PEANUTS
PROJECT........................................................Aflatoxin testing of domestic and imported
peanuts
LEADERS.......................................................Administrator, Agricultural Marketing
Service (AMS), United States Department of
Agriculture (USDA) and Acting Director,
Center for Food Safety and Applied
Nutrition, Food and Drug Administration
(FDA), Department of Health and Human
Services (HHS)
LOCATIONS...................................................Blakely, Georgia, and Suffolk, Virginia
HEADQUARTERS.............................................Washington, DC
EFFECTIVE DATE............................................November 22, 2010
LEGAL AUTHORITY..........................................The Agricultural Marketing Act of 1946,
and the Federal Food, Drug, and Cosmetic
Act
REVISION......................................................This is a revision of and shall supersede
Memorandum of Understanding, FDA-225-
96-2001, 225-96-2002, and 225-96-2003
effective October 1, 1997, 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 Programs (S&T), 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.
USDA administers the Minimum Quality
and Handling Standards for Domestic and
Imported Peanuts Marketed in the
United States to control the aflatoxin
problem in peanuts and ensure the
wholesomeness of peanuts moving into
channels for human consumption. The
limit for domestic edible peanuts is 15
parts per billion (Ppb) total aflatoxins or
less as stated in 7 CFR section 996.11.
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 USDA -
approved laboratory for inspection before
introducing that lot into United States
commerce.
United States to control the aflatoxin
problem in peanuts and ensure the
wholesomeness of peanuts moving into
channels for human consumption. The
limit for domestic edible peanuts is 15
parts per billion (Ppb) total aflatoxins or
less as stated in 7 CFR section 996.11.
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 USDA -
approved laboratory for inspection before
introducing that lot into United States
commerce.
RESPONSIBILITIES:
AMS intends to:
1. Continue to administer the USDA laboratory approval program for the testing of
peanuts for aflatoxin to control the incidence and levels of aflatoxin in
domestically produced peanuts.
2. Monitor and inspect imported raw peanuts upon effective date of peanut import
regulations.
3. Perform all aflatoxin assays using only the official methods permitted by USDA,
AMS, S&T, Technical Services Branch (TSB).
4. Issue aflatoxin certificates as (1) "negative" if the level is not over 15 ppb; or (2)
enter the exact number on the certificate if the level is over 15 ppb.
5. Provide FDA with a summary of total aflatoxin analyses completed each quarter
to include: total number of lots examined, number containing aflatoxins, range of
levels, and the name of the applicant for each lot containing aflatoxins. Details on
individual lots will be made available to FDA upon request.
FDA intends to:
1. Maintain its administrative guideline that an aflatoxin level up to 20 ppb on
objective samples generally is not expected to result in adulteration because
current good manufacturing practices remove significant quantities of unfit
peanuts and 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.
PART II, BRAZIL NUTS
PROJECT........................................................Voluntary aflatoxin testing of imported in-
shell Brazil nuts
LEADERS.......................................................Administrator, Agricultural Marketing
Service (AMS), United States Department of
Agriculture (USDA) and Acting Director,
Center for Food Safety and Applied
Nutrition, Food and Drug Administration
(FDA), Department of Health and Human
Services (HHS)
Agriculture (USDA) and Acting Director,
Center for Food Safety and Applied
Nutrition, Food and Drug Administration
(FDA), Department of Health and Human
Services (HHS)
LOCATIONS....................................................Blakely, Georgia
HEADQUARTERS..............................................Washington, DC
EFFECTIVE DATE.............................................November 22, 2010
LEGAL AUTHORITY...........................................The Agricultural Marketing Act of 1946,
and the Federal Food, Drug, and Cosmetic
Act
and the Federal Food, Drug, and Cosmetic
Act
REVISION......................................................This is a revision of and shall supersedez
Memorandum of Understanding, FDA-
225-96-2002, effective October 1, 1997,
between FDA and AMS.
225-96-2002, effective October 1, 1997,
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 Programs (S&T), AMS.
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 Programs (S&T), 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.
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 Number of bags Total pounds Approximate
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 Number of bags Total pounds Approximate
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, 18th ed.,
Chapter 49.2.09, or other official method permitted by USDA, AMS,
S&T, Technical Services Branch (TSB). 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 compo sited 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 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 Federal 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 Federal Food, Drug,
and Cosmetic Act.
PART III, PISTACHIO NUTS
PROJECT...................................................... Voluntary aflatoxin testing of imported
in-shell pistachio nuts
in-shell pistachio nuts
LEADERS.......................................................Administrator, Agricultural Marketing
Service (AMS), United States Department of
Agriculture (USDA) and Acting Director,
Center for Food Safety and Applied
Nutrition, Food and Drug Administration
(FDA), Department of Health and Human
Services (HHS)
Service (AMS), United States Department of
Agriculture (USDA) and Acting Director,
Center for Food Safety and Applied
Nutrition, Food and Drug Administration
(FDA), Department of Health and Human
Services (HHS)
LOCATIONS....................................................Blakely, Georgia
HEADQUARTERS..............................................Washington, DC
EFFECTIVE DATE.............................................November 22, 2010
LEGAL AUTHORITY...........................................The Agricultural Marketing Act of 1946,
and the Federal Food, Drug, and Cosmetic
Act
and the Federal Food, Drug, and Cosmetic
Act
REVISION......................................................This is a revision of and shall supersede
Memorandum of Understanding, FDA-
225-96-2003, effective October 1, 1997,
between FDA and AMS.
Memorandum of Understanding, FDA-
225-96-2003, effective October 1, 1997,
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 Programs (S&T), AMS.
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 Programs (S&T), 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.
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:
Total weight Percent of Total sample
of lot ____ containers sampled weight_____
75,000 lbs or less Minimum of 20% Shelled - 25 lbs
In-shell - 50 lbs
More than 75,000 1bs Maximum of 20% Shelled – 50 1bs
To 150,000 lbs In-shelled – 100 lbs
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 lbs of shelled nuts or 50 lbs of in-shell nuts for each multiple of 75,000 lbs (e.g., 150,000 to 225,000 lbs requires a 3-fold sample of 75 lbs shelled or 150 lbs 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 the official method for
aflatoxin assay in pistachios described in the book of Official Methods of
Analysis of AOAC International, 18th ed., Chapter 49.2.23, or other
method permitted by USDA, AMS, S&T, Technical Services Branch
(TSB). 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 Federal 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 Federal Food, Drug,
and Cosmetic Act.
AMS and FDA mutually agree to:
1. Designate a person to serve as a central contact to who communications dealing
with this agreement or matters affected thereby may be first referred for attention.
For the Food and Drug Administration:
Director, Division of Plant and Dairy Food Safety,
HFS-315 (currently John F. Sheehan),
Office of Food Safety
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Telephone: 301-436-1488
For the Agricultural Marketing Service:
Deputy Administrator, Science and Technology Programs
(currently Robert L. Epstein)
USDA, AMS
14th & Independence Avenue, S.W.
Washington, D.C. 20250
Telephone: 202-720-5231
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 it 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 for five years from effective date. 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.
Approved and Accepted for the Agricultural Marketing Service Signed by: Rayne Pegg Administrator Agricultural Marketing Service Date: December 23, 2010 | Approved and Accepted for the Food and Drug Administration Signed by: Michael Landa Acting Director Center for Food Safety and Applied Nutrition Date: January 5, 2011 |
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