[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]


-----------------------------------------------------------------------

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