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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. 

 
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)
 
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
 
REVISION......................................................This is a revision of and shall supersedez
                                                                   Memorandum of Understanding, FDA-
                                                                   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.
 
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          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
 
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
 
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-
                                                                   225-96-2003, 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 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:
 
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