oversight

Food Safety and Quality: Who Does What in the Federal Government

Published by the Government Accountability Office on 1990-12-21.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

_____      - ._____._   _ _ _.-_..   - _.-._   .._..___   . .._ -.   . . .._ .._.   .-,l.l_*-   -..-__(.-   ".-.----.--.-.-----

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                                                                                            FOOD SAFETY
                                                                                            AND QUALITY
                                                                                            Who Does What in the
                                                                                            Federal Government


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                                                                                                                                  RELEASED
                                                                                    RESTRICTED --Not      to be released outside the
                                                                                    General Accounting Of&e unless specifically
                                                                                    approved by the Office of Congressional
                                                                                    Relations.
                       3
_.,   _   --_.-.___-




                           .
      United States
GAO   General Accounting Office
      Washington, D.C. 20648

      Resources, Community,   and
      Economic Development    Division

      B-240663

      December 21,lQQO

      The Honorable Patrick J. Leahy
      Chairman, Committee on Agriculture,
      Nutrition and Forestry
      United State Senate

      The Honorable Tom Harkin
      United States Senate

      The Honorable Dennis E. Eckart
      House of Representatives

      This is the second volume of our report to you in response to your
      requests for information on the federal agencies involved with food
      safety and aualitv activities. In the first volume, also entitled Food
      Safety and &ality: Who Does What in the Federal Government (GAO/
      WED-91-19A), we presented a brief summary of the results of our review.
      This report contains a more detailed description of the food safety and
      quality activities of the 12 federal agencies discussed in the first
      volume.

      As arranged with your offices, unless you publicly announce its contents
      earlier, we plan no further distribution of this report until 30 days from
      the date of this letter. At that time, we will send copies to the Secretary
      of Agriculture; the Secretary of Commerce; the Secretary of Health and
      Human Services; the Commissioner, Food and Drug Administration; the
      Administrator, Environmental Protection Agency; and other interested
      parties. Please call me on (202) 2755138 if you have any questions con-
      cerning the report. Other major contributors to this report are listed in
      appendix I.




      John W. Harman
      Director, Food and
        Agriculture Issues




      Page 1                      GAO/RCED-Bl-19B   Federal Food Safety and Quality   Programs
Preface


          This is a companion to Volume A, Food Safety and Quality: Who Does
          What in the Federal Government (GAO/RCED-91-19A), which summarizes
          information concerning federal agency food safety and quality activi-
          ties. This volume, arranged by agency, contains a more detailed descrip-
          tion of the food safety and quality activities of the 12 federal agencies
          discussed in the first volume.

          For the purposes of our review, we defined food safety activities as
          those carried out to assure that food is safe, sanitary, wholesome, and
          properly labeled. Food quality activities are defined as those estab-
          lishing standards of quality and condition, grading food products
          according to the standards, certifying that food products meet the stan-
          dards, and inspecting food products for compliance with the standards.

          The six principal agencies are the Food and Drug Administration of the
          U.S. Department of Health and Human Services (HHS); Agricultural Mar-
          keting Service, Federal Grain Inspection Service, and Food Safety and
          Inspection Service of the U.S. Department of Agriculture (USDA); the
          Environmental Protection Agency; and the National Marine Fisheries
          Service of the U.S. Department of Commerce. For these agencies,
          detailed information is included on (1) major legislation, (2) organiza-
          tional units and responsibilities, (3) program activities, (4) funding
          levels, (5) staffing levels, (6) agreements with other federal agencies,
          and (7) critical food safety and quality issues of the 1990s.

          Also, although we requested that the agencies provide funding, staffing,
          and workload data for fiscal years 1980 through 1989, some agencies
          did not provide certain data for each of these years because of changes
          in organization and/or responsibilities or because the data were
          destroyed pursuant to agency records retention guidelines. Conse-
          quently, some tables in this report do not include data back to fiscal
          year 1980. We did not convert the dollar amounts in the tables in this
          volume to constant dollars.

          The six other federal agencies that play an important, but less signifi-
          cant, role in helping to ensure food safety and quality are USDA'S Agri-
          cultural Research Service and Animal and Plant Health Inspection
          Service; the Department of the Treasury’s Bureau of Alcohol, Tobacco
          and Firearms and United States Customs Service; HHS' Centers for Dis-
          ease Control; and the Federal Trade Commission. For these agencies,
          information similar to that for the six principal agencies is presented,
          but in less detail.



          Page 2                   GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
Page 3   GAO/RCJ!DNl~l@B   Federal Food Safety and Quality   Programs
                                            Preface




Figure 1: Federal Agency Food Safety and Ouality Responsibilities
                                                      U.S. Dopartmont of Hoaith
U.S. Department of Agricuituro                          and Human Sorvioea                           Environmental Protection Agency



  Food Safety and Inspection                     Food and Drug Adminletration                               Regulate Pe8Ucider

                                                      Safety of All Foods, Except                           Establish Pesticide
    Meat   end Poultry Safety                          Meat, Poultry, and Egg8                               Tolerance Level8
                                                                                                     I---
                                                           Safety of Animal
                                                           Drug8 and Feed8




 Agrkultural    Marketing Service                Center8 for Dbare       Control
    Egg/Egg Product Safety                             Investigate Foodbome
                                                         Disea8e   Problems
     inspect/&ado    Quality
       of Egg, Dairy, Fruit,
     Vegetable, Meat, and
         Pouitty Product8




    Federal Qraln inepection
               &Nice


 Inspect Quailty of Grain, Rice,
     and Related Product8           I




I---
    Animal end Plant Health
       Inspection Service

   Protect Animal8 and Pianta
    From Dissa8e and Pests




     Agricultural Research
               &Nice


      Perform Food Safety
            Research                I




                                            Page 4                                  GAO/RCEDOl-19B   Federal Feud Safety and Quality   Programa
U.S. Dapartmmnt of tha Ttaaauty                                    Fodoral Trade Commlsaion



  Bureau of Alcohol, Tobacco                                         Regulate Advertising
         and Flrearrnr                                                of Food Products
      Regulate Production,
    Diatributlon, and Labeling
                                                            I---
     of Alcoholic Beveragea




 United State0 Cuatornr Swvlce

     Examine/Collect Food
      Import Sample8 for
    Other Federal Agonckr




                                  Page 6   GAO/WED-91.19B   Federal Food Safety and Quality Programs
Readers’Guide


                Subject                                                                        Report
                                                                                                 Part

                Advertising of Food Products                                                          7

                Alcoholic Beverages
                  Production and distribution authority                                                 7
                  Safety                                                                                7

                Animal
                  Drugs and medicated feed approval and enforcement                                     1
                  Protection from disease and pests                                                     7

                Dairy Products
                  Grade A drinking milk                                                                 1
                  Milk for manufacturing purposes                                                       4
                  Quality inspection and grading                                                        4
                  Safety                                                                                1
                  Standards of quality and condition                                                    4

                Drinking Water Safety                                                                   1

                Eggs and Egg Products
                  Exported products                                                                     4
                  Imported products                                                                     4
                  Quality grading                                                                       4
                  Restaurants, institutions, and food-manufacturing plants                              1
                  Safety                                                                                4
                  Standards of quality and condition                                                    4

                Food and Color Additives                                                                1

                Fruits and Vegetables
                  Standards of quality and condition                                                    4

                Grain, Rice, and Related Commodities
                  Exported products                                                                     5
                  Quality inspections                                                                   5
                  Standards of quality and condition                                                    5

                Meat and Poultry Products
                 Animal disease prevention                                                              7
                 Animal drug and medicated feed approval                                                1


                Page 6                     GAO/RCED-Ol-LOB   Federal Food Safety and Quality   pro(pame
Readers’ Guide




  Imported products
  Monitoring state inspection programs
  Plant sanitation
  Product formula and label approval
  Quality grading inspections
  Residue testing
  Safety inspection
  Standards of quality and condition

Pesticides
  Regulation                                                                        2
  Tolerance enforcement                                                          1,394
  Tolerance setting                                                                 2

Plant Disease and Pest Control                                                       7

Seafood Products
  Approval of drugs and feed additives used in aquaculture
  Imported products
  Monitoring state inspection programs
  Quality grading inspections
  Residue testing
  Standards of quality and condition

State Inspection Programs
  Fruits and vegetables                                                              4
  Meat and poultry                                                                 3,4
  Milk                                                                             I,4
  Pesticides                                                                         2
  Seafood                                                                          lb3




Page 7                    GAO/RCED-91.19B   Federal Food Safety and Quality   Programs
Contents



Preface
Readers’Guide
Part 1                                                                                                     14
Food and Drug            Major Legislation
                         Organizational Units and Responsibilities
                                                                                                           14
                                                                                                           16
Administration           Program Activities                                                                17
Activities Relating to   Funding Levels                                                                    29
                         Staffing Levels                                                                   30
Food Safety and          Coordination With Other Federal Agencies                                          30
Quality                  Critical Food Safety and Quality Issues Facing FDA                                33
                               During the 1990s

Part 2                                                                                                     35
Environmental            Major Legislation
                         Organizational Units and Responsibilities
                                                                                                           35
                                                                                                           36
Protection Agency        Program Activities                                                                37
Activities Relating to   Funding Levels                                                                    41
                         Staffing Levels                                                                   42
Pesticide Regulation     Coordination With Other Federal Agencies                                          43
and Tolerance Levels     Critical Food Safety and Quality Issues Facing EPA                                44
                               During the 1990s

Part 3                                                                                                     48
Food Safety and          Major Legislation                                                                 48
                         Organizational Units and Responsibilities                                         48
Inspection Service       Program Activities                                                                49
Activities Relating to   Funding Levels                                                                    52
                         Staffing Levels                                                                   53
Meat and Poultry         Coordination With Other Federal Agencies                                          55
Safety and Quality       Critical Food Safety and Quality Issues Facing FSIS                               56
                               During the 1990s




                         Page 8                  GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
                         Contents




Part 4                                                                                                     58
Agricultural             Major Legislation
                         Organizational Units and Responsibilities
                                                                                                           58
                                                                                                           59
Marketing Service        Program Activities                                                                59
Activities Relating to   Funding Levels                                                                    72
                         Staffing Levels                                                                   73
Safety and Quality of    Coordination With Other Federal Agencies                                          74
Egg, Dairy, Fruit,       Critical Food Safety and Quality Issues Facing AMS                                76
Vegetable,Meat, and            During the 1990s
Poultry Products
Part 5                                                                                                     79
Federal Grain            Major Legislation
                         Organizational Units and Responsibilities
                                                                                                           79
                                                                                                           80
Inspection Service       Program Activities                                                                82
Activities Relating to   Funding Levels                                                                    84
                         Staffing Levels                                                                   85
Safety and Quality of    Coordination With Other Federal Agencies                                          86
Grain, Rice, and         Critical Food Safety and Quality Issues Facing FGIS                               86
Related Commodities            During the 1990s

Part 6                                                                                                     88
National Marine          Major Legislation
                         Organizational Units and Responsibilities
                                                                                                          88
                                                                                                          89
Fisheries Service        Program Activities                                                               91
Activities Relating to   Funding Levels                                                                   97
                         Staffing Levels                                                                  98
SeafoodSafety and        Coordination With Other Federal Agencies                                         99
Quality                  Critical Food Safety and Quality Issues Facing NMFS                             100
                               During the 1990s

Part 7                                                                                                   105
Other SelectedFederal    Agricultural Research Service
                         Animal and Plant Health Inspection Service
                                                                                                         105
                                                                                                         107
Agencies Involved        Bureau of Alcohol, Tobacco and Firearms                                         110
With Food Safety and     Centers for Disease Control                                                     113
                         Federal Trade Commission                                                        115
Quality Activities       United States Customs Service                                                   116




                         Page 9                  GAO/RCED-Ql-1QB   Federal Food Safety and Quality   Programs
                        Contents




Appendix I                                                                                           I19
Major Contributors to
This Report
Tables                  Table 1.1: Domestic Food Inspections and Samples                               24
                            Analyzed by or for FDA for Selected Fiscal Years
                        Table 1.2: Wharf Examinations Conducted and Samples                            25
                            Examined by FDA Relating to Imported Food, Fiscal
                            Years 1984-89
                        Table 1.3: FDA Import Detentions, Fiscal Years 1988-89                         26
                        Table 1.4: Seizures, Injunctions, and Prosecutions Relating                    27
                            to Food Safety and Quality, Fiscal Years 1988-89
                        Table 1.5: Amounts Available for FDA’s Food and                                29
                            Cosmetics Program and Animal Drugs and Feeds
                            Program for Selected Fiscal Years
                        Table 1.6: Staffing Levels for FDA Offices Involved W ith                      30
                            Food Safety and Quality Activities for Selected Fiscal
                            Years
                        Table 2.1: Selected Pesticide Enforcement Activity Data                        41
                            for States, Territories, and Indian Tribes, Fiscal
                            Years 1988-90
                        Table 2.2: EPA/OPP Obligations, Fiscal Years 1980-89                           42
                        Table 2.3: EPA/OPP Full-Time Equivalent Staffing Levels,                       43
                            Fiscal Years 1980-89
                        Table 3.1: Laboratory Samples Analyzed by FSIS, Fiscal                         51
                            Years 1988-90
                        Table 3.2: Funds Available to FSIS, Fiscal Years 1988-90                       53
                        Table 3.3: FSIS Staff Years by Program Area, Fiscal Years                      54
                            1988-90
                        Table 3.4: FSIS Resources and Inspection Activities, Fiscal                    54
                            Years 1980-89
                        Table 4.1: A M S Shell Egg and Egg Products Inspection                         61
                            Data, Fiscal Years 1988-90
                        Table 4.2: Compliance and Enforcement Cases Closed by                          62
                            A M S During Fiscal Years 1988-89
                        Table 4.3: A M S Dairy Inspection and Grading Data, Fiscal                     65
                            Years 1988-90
                        Table 4.4: A M S Fruit and Vegetable Inspection and                            68
                            Grading Data, Fiscal Years 1988-90
                        Table 4.5: A M S Meat Grading and Certification Data,                          69
                            Fiscal Years 1988-90


                        Page 10                  GAO/RCED-Ql-1QB Federal Food Safety and Quality Programs
         Contents




         Table 4.6: AMS Poultry-Grading Data, Fiscal Years                                 70
              1988-90
         Table 4.7: Selected AMS Inspection/Grading Workload                               72
             Data, Fiscal Years 1980, 1985, and 1989
         Table 4.8: AMS Obligations for Food Safety and Quality                            73
             Activities, Fiscal Years 1988-90
         Table 4.9: AMS Staff Years for Food Safety and Quality                            74
             Activities, Fiscal Years 1988-90
         Table 5.1: FGIS’Appropriated and Fee-Supported                                    85
             Expenditures, Fiscal Years 1987-89
         Table 5.2: FGIS Full-Time Permanent and Part-Time                                 85
             Employee Staffing Levels at End of Fiscal Years
             1987-89
         Table 5.3: FGIS Resources and Inspection Activities,                              85
             Fiscal Years 1980, 1985, and 1989
         Table 6.1: NMFS Export Inspection Certificates Issued,                            93
             Calendar Years 1984-89
         Table 6.2: NMFS-Inspected Fishery Products, Calendar                              94
             Years 1981-89
         Table 6.3: Value of Edible Processed Fishery Products,                            94
             Calendar Years 1980-88
         Table 6.4: NMFS Laboratory Tests, Fiscal Years 1981-89                            95
         Table 6.5: Funding of NMFS Food Safety and Quality                                98
             Activities, Fiscal Years 1988-89
         Table 6.6: Staffing Levels for NMFS’ Food Safety and                              99
             Quality Activities, Fiscal Years 1988-89

Figure   Figure 1: Federal Agency Food Safety and Quality                                   4
             Responsibilities




         Page 11                 GAO/RCED-91-19B   Federal Food safety and Quality   Programs
Abbreviations

AMS       Agricultural Marketing Service
APHIS     Animal and Plant Health Inspection Service
ARS       Agricultural Research Service
ATF       Bureau of Alcohol, Tobacco and Firearms
CM:       Centers for Disease Control
CSRS      Cooperative State Research Service
EPA       Environmental Protection Agency
FDA       Food and Drug Administration
FFDCA     Federal Food, Drug, and Cosmetic Act
FGIS      Federal Grain Inspection Service
FIFRA     Federal Insecticide, Fungicide, and Rodenticide Act
ISIS      Food Safety and Inspection Service
FIX       Federal Trade Commission
GAO       General Accounting Office
HHS       Department of Health and Human Services
NMFS      National Marine Fisheries Service
NOAA      National Oceanic and Atmospheric Administration
OPP       Office of Pesticide Programs
PPIA      Poultry Products Inspection Act
PUFI      Packed Under Federal Inspection
USDA      U.S. Department of Agriculture
USGSA     US. Grain Standards Act


Page 12                  GAO/RCED-Ql-1QB   Federal Food Safety and Quality   Programs
Page 19   GAO/RCED-91.19B   Federal Food Safety and Quality   Program
                                                                                                                  ,
Part 1

Food and Drug A dministration Activities                                                                     1
Relating to Food Safety and Quality

                              The Food and Drug Administration (FDA) is responsible for ensuring that
                              domestic and imported food products (except meat and poultry prod-
                              ucts) are safe, sanitary, nutritious, and wholesome; and are honestly
                              labeled. The U.S. Department of Agriculture (USDA) has jurisdiction over
                              meat and poultry products and shares responsibility for egg products
                              with FDA.

                              The Federal Food, Drug,, and Cosmetic Act (FFDCA), as amended (21
Major Legislation             U.S.C. 301 et seq.), is the major law relating to FDA'S food safety and
                              quality activities.


Federal Food, Drug, and       The FFDCA authorizes FDA to (1) regulate food (except meat and poultry
Cosmetic Act                  products) production and manufacturing to ensure that food is safe,
                              clean, and wholesome and (2) establish reasonable standards of identity,
                              quality, and fill of container for food products. The act also (1) requires
                              FDA to review and approve food and color additives before they can be
                              marketed and (2) prohibits the interstate commerce of adulterated foods
                              and false or misleading labeling of food products. A food is adulterated
                              if it contains substances that may render it injurious to health. A food is
                              misbranded if information required by law does not clearly appear on
                              the label.

                              The act also directs FDA to maintain surveillance of all animal drugs,
                              feeds, and veterinary devices marketed in interstate commerce to ensure
                              their compliance with the act. The act requires that all animal drugs
                              that are not generally recognized as safe and effective be approved by
                              FDAbefore marketing on the basis of studies made by the sponsor. How-
                              ever, the act permits the export of an unapproved animal drug under
                              certain conditions.

                              The act also mandates that FDA inspect every registered animal drug and
                              medicated feed-manufacturing facility at least once every 2 years. FDA
                              reviews the facilities, manufacturing procedures and controls, formula-
                              tions, and labeling relating to marketed products to determine their com-
                              pliance with the act and FDA regulations.


Other Legislation             Other laws affecting FDA'S food safety activities include the
Affecting FDA’s Food        Public Health Service Act, as amended (42 U.S.C. 201 et seq.);
Safety Activities         l


                          l Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. 1401 et seq.);
                          . Egg Products Inspection Act, as amended (21 USC. 1031 et seq.);


                              Page 14                         GAO/RCED-Ol-19B   Federal Food Safety and Quality   Programs




                                                                                                                      ‘”
                                                    ,   .,,
    Part1
    Food and Drug Administratjon  ,Activities
    Relating to Food 8afety and Quality




. Safe Drinking Water Act, as amended (21 USC. 349);
. Infant Formula Act of 1980, as amended (21 U.S.C. 350a);
l Federal Anti-Tampering Act (18 U.S.C. 1365); and
. Federal Import Milk Act, as amended (21 U.S.C. 141).

    The Public Health Service Act provides for federal/state cooperative
    assistance in preventing the interstate transmission of disease, and thus
    establishes FDA'S authority for its programs for sanitation in milk
    processing, shellfish, restaurant and retail market operations, and inter-
    state travel conveyances.

    The Pesticide Monitoring Improvements Act requires FDA to (1) develop
    new, or modify existing, data management systems to track, summarize,
    and evaluate pesticide-monitoring data; (2) enter into cooperative agree-
    ments with foreign countries to obtain pesticide usage data on crops
    imported from those countries; and (3) develop an analytical methods
    research plan to guide the development of methods to improve the effi-
    ciency of food monitoring.

    Under the Egg Products Inspection Act, the Agricultural Marketing Ser-
    vice (AMS) is responsible for inspecting egg product processing plants
    and firms marketing eggs, while FDA is responsible for inspecting restau-
    rants, institutions, and food-manufacturing establishments that serve
    eggs or use them in their products.

    The Safe Drinking Water Act requires FDA, in consultation with the Envi-
    ronmental Protection Agency (EPA), to establish regulations relating to
    bottled drinking water standards. Pursuant to the act, FDA has estab-
    lished standards of quality and current good manufacturing practice
    regulations for processing and bottling waters.

    The Infant Formula Act of 1980 established nutrient requirements for
    infant formulas and gave FDA authority to establish requirements for
    quality control, record keeping, reporting, and recall procedures. The act
    also extended FDA'S factory inspection authority to permit access to
    manufacturers’ records and test results necessary to determine
    compliance.

    The Federal Anti-Tampering Act provides for monetary penalties and
    imprisonment for tampering with consumer products, including food,
    and their labeling and packaging that affect interstate and foreign com-
    merce. FDA is responsible for investigating violations of the act relating
    to products it regulates.


    Page 15                           GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
                       Part1
                       Food and Drug Adminbtration Activities
                       Relaliug to Food Safety and Quality




                       Under the Federal Import Milk Act, milk and cream may be imported
                       into the United States only under a permit from the Secretary of Health
                       and Human Services (HHS) after certain sanitary and other prerequisites
                       have been fulfilled.


                       At FDA headquarters in the Washington, D.C., area, three main offices
Organizational Units   carry out food safety and quality activities-the Center for Food Safety
and Responsibilities   and Applied Nutrition, the Center for Veterinary Medicine, and the
                       Office of Regulatory Affairs.

                       The Center for Food Safety and Applied Nutrition carries out FDA'S Food
                       and Cosmetics Program. The Center (1) conducts and supports food
                       safety research, (2) develops and oversees enforcement of food safety
                       and quality regulations, (3) coordinates and evaluates FDA'S surveillance
                       and compliance programs relating to foods, (4) coordinates and evalu-
                       ates federal/state cooperative programs relating to foods, and (5)
                       develops and disseminates food safety and regulatory information to
                       consumers and industry.

                       The Center for Veterinary Medicine carries out FDA'S Animal Drugs and
                       Feeds Program, which includes ensuring that drugs and feeds used in
                       animals are safe, effective, and properly labeled; and produce no human
                       health hazards when used in food-producing animals. It is also respon-
                       sible for monitoring animal drug sales and distribution as well as good
                       manufacturing practices associated with animal drug and medicated
                       feed production,

                       The Office of Regulatory Affairs consists of a headquarters staff and
                       FDA field offices. The headquarters staff oversees field office activities.
                       Field offices conduct investigational and laboratory functions for all of
                       FDA'S major product areas- foods, human drugs, animal drugs and
                       feeds, and medical devices and radiological products. Field office food
                       safety and quality responsibilities include those relating to research,
                       investigations, inspections, compliance, enforcement, and laboratory
                       analyses,


FDA Field Facilities   In fiscal year 1989, FDA maintained offices and staff in 49 states, the
                       District of Columbia, and Puerto Rico. FDA field facilities include 6
             w         regional offices, 21 district offices, 18 district laboratories, and 136 resi-
                       dent posts.



                       Page 16                         GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
       L                         P&l
                                 Food and Drug Administration  Activities
                                 Relating to Food Safety and Quality




                                 The regional offices coordinate the activities of the various FDA offices
                                 in their regions and coordinate FDA activities with state authorities. The
                                 district offices serve as offices for investigators and compliance action
                                 staff and are the main control point for day-to-day operations. The dis-
                                 trict laboratories, located within the district offices, provide facilities to
                                 test products for safety and to conduct the research necessary to eval-
                                 uate health hazards and to develop the means to detect product hazards
                                 and prevent them. Resident posts are smaller offices which serve as a
                                 base for investigators so that FDA can have investigative staff widely
                                 dispersed to respond to emergencies as well as to save investigational
                                 travel costs and time.


                                 Manufacturers subject to FDA'S jurisdiction are primarily responsible for
Program Activities               ensuring the safety of their products. FDA'S role is to monitor the food
                                 industry and to provide the consumer with the best assurances possible
                                 that the industry is meeting its responsibility. FDA characterizes its
                                 activities as primarily preventive rather than corrective. It does not
                                 have sufficient resources to continually police every segment of the food
                                 industry and the other industries it regulates. Its strategy, therefore, is
                                 designed to ensure that safety is built into products rather than to check
                                 for safety after products have been produced.

                                 PDA has oriented its food inspection program to perform in-depth inspec-
                                 tions of those firms producing commodities having a high potential for
                                 causing risks to health if established processes are not adequately con-
                                 trolled. FDA also expands its surveillance of the nation’s food supply
                                 through cooperative relationships with state and local regulatory
                                 agencies.

                                 The food safety and quality activities of the Center for Food Safety and
                                 Applied Nutrition, the Center for Veterinary Medicine, and the Office of
                                 Regulatory Affairs are discussed below. Topics discussed include inspec-
                                 tion activities, import activities, export activities, enforcement activi-
                                 ties, and FDA'S relationship to state inspection programs.


Center for Food Safety and       The Center carries out the following 10 projects of FDA'S Food and Cos-
Applied Nutrition                metics Program:
Activities *                 l   Food Composition, Standards, Labeling, and Economics;
                         l       Foodborne Biological Hazards;
                             l   Diet/Toxicity Interaction;


                                 Page 17                          GAO/RCEDBl-19B   Federal Food Safety and Quality   Programs
                                   Food and kug Adminbtratlon    Activities
                                   Relating to Food Safety and QueUty




                               9 Molecular Biology and Natural Toxins;
                               . Pesticides and Chemical Contaminants;
                               . Risk Assessment Research and Policy Development;
                               l Food and Color Additive Petition Review and Policy Development;
                               . Colors and Cosmetics Technology;
                               l Postmarket Surveillance and Epidemiology; and
                               l Technical Assistance.

                                   The following are brief descriptions of the Center’s food safety and
                                   quality activities relating to the 10 projects.

Food Composition, Standards,       This project’s mission is intended to ensure that food quality and safety
Labeling, and Economics            are maintained and/or improved through product formulation,
                                   processing, fortification, and other measures; informative food labeling
                                   is provided to consumers; the consumer is not economically harmed by
                                   misleading labeling or packaging; and product integrity is maintained
                                   through the development, promulgation, and enforcement of standards.
                                   Project activities include

                               l developing information on food composition, nutrition status, and bio-
                                 chemistry of food components;
                               . establishing guidelines and labeling standards for traditional foods and
                                 foods for special dietary use;
                               l developing and revising standards for food to ensure identity, quality,
                                 and fill of container; and
                               l investigating potential economic abuses and establishing and enforcing
                                 regulations to prevent or minimize such abuse.

Foodborne Biological Hazards       This project involves surveillance, enforcement, and prevention of food-
                                   borne safety problems that are caused by microbial contamination and
                                   adulteration by rodent, bird, and animal filth; and insect infestation. Its
                                   mission is to reduce the incidence of microbiological hazards, filth,
                                   decomposition, and foreign objects in the nation’s food supply. Project
                                   activities include

                               . developing new procedures for use by FDA and other organizations to
                                 improve methods for isolating and identifying foodborne strains of path-
                                 ogenic microorganisms;
                               l surveying various food commodities for the presence of newly defined
                                 microbial hazards to provide better ways of monitoring the food supply;
                               l inspecting food-manufacturing establishments and imported foods to
                                 identify and eliminate conditions due to filth, decomposition, and for-
                                 eign objects that may cause a hazard to health;


                                   Page 18                          GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
                                    Part1
                                    Food and Drug Administration  Activities
                                    Relating to Food Safety and Quality




                                    negotiating memorandums of understanding with foreign countries that
                                    export food to the United States regarding the certification that their
                                    food products were processed in accordance with manufacturing prac-
                                    tices that provide adequate quality control; and
                                    conducting enforcement and surveillance operations with respect to san-
                                    itation practices of interstate conveyances (aircraft, buses, passenger
                                    trains, and vessels) and their support facilities handling food, water,
                                    and wastes.

Diet/Toxicity Interaction           This project’s mission is intended to ensure that the safety and nutri-
                                    tional adequacy of foods are maintained and/or improved through iden-
                                    tifying and evaluating nutrient toxicities and factors modifying them,
                                    impacts of toxic substances on nutrient requirements and functions, and
                                    impacts of diet and nutrients on toxic effects. Project activities include

                                . performing studies on the health effects of nutrient excess, such as high
                                  doses of vitamin A;
                                . evaluating the effects of nutrition and diet on toxicological endpoints,
                                  such as relating fiber intake and type to the development and progress
                                  of colon cancer; and
                                . studying the effects of toxicants on nutritional endpoints, such as the
                                  effects of tin on bone mineralization and on nerve function.

Molecular Biology and Natural       This project’s mission is intended to conduct research appropriate to
Toxins                              gaining a clear understanding of host-parasite interactions as they relate
                                    to foodborne microorganisms, to assess their true impact on public
                                    health, and to identify microbial attributes contributing to both acute
                                    and chronic disease processes. Project activities include

                                    applying biotechnology to determine the pathogenic attributes (those
                                    contributing to acute and chronic disease) possessed by foodborne
                                    microbes;
                                    studying the ecological, biological, and physical interactions, accumula-
                                    tion, stability, and chemical structure of marine toxins and evaluating
                                    their true impact on consumer health;
                                    developing and applying methodologies to better isolate and purify bio-
                                    logically active products of foodborne microbes so that their impact
                                    alone, and collective impacts, on host defenses can be assessed;and
                                    conducting basic research in microbial genetics.

Pesticides and Chemical             This project’s mission is intended to ensure that the consumer is pro-
Contaminants                        tected against undue risk from pesticides and chemical contaminants in
                                    the food supply. Project activities include


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                                   . developing information to identify and evaluate pesticide and chemical
                                     contaminant problems;
                                   l developing an analytical methodology for measuring trace amounts of
                                     pesticides and chemical contaminants in food;
                                   l determining the frequency and level of occurrence of pesticides and
                                     chemical contaminants in the food supply, including field surveys and
                                     FDA'S Total Diet Study;
                                   . carrying out toxicologic studies to determine the toxic behavior of chem-
                                     ical contaminants and epidemiologic studies to determine the effects of
                                     chemical contaminants on humans;
                                   . establishing regulatory limits for chemical contaminants in food, where
                                     appropriate; and
                                   . carrying out field-monitoring programs for selected chemical contami-
                                     nants in foods of dietary importance and taking regulatory action where
                                     warranted.

Risk Assessment Research and               This project’s mission includes providing information obtained from lab-
Policy Development                         oratory experimentation to reduce uncertainties in risk assessment for
                                           hazardous substances in foods. The project generalizes the information
                                           obtained from experiments to form the basis for developing emerging
                                           policy. Project activities include

                                   l     developing and evaluating models for identifying toxic hazards associ-
                                         ated with food additives;
                                       . conducting studies on the modulating effect of dietary substances on
                                         responses to known toxicants;
                                       l conducting pharmacokinetic studies to trace the fate of hazardous sub-
                                         stances within the body and the effect of different exposures on distri-
                                         bution; and
                                       . determining dose/effect relationships associated with the incidence and
                                         severity of hazardous substances’effects.

Food and Color Additive Petition           This project’s mission is to ensure that the use of food and color addi-
Review and Policy Development              tives is safe by evaluating new petitions and developing and maintaining
                                           a data base necessary for evaluation and monitoring. The project also
                                           develops policies that direct agency resources to issues of greater con-
                                           cern and anticipate future trends and technological advances. Project
                                           activities include

                                       . reviewing technical data submitted for food and color additive petitions,
                                         or technical data for affirmation petitions for additives generally recog-
                                         nized as safe;



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                                  .   conducting inspections to ensure that food and color additives are prop-
                                      erly used in manufacturing food;
                                  .   examining food products and food contact surfaces for the presence of
                                      unapproved or excessive amounts of food additives;
                                  .   developing new analytical methodologies to determine the presence of
                                      additives in food;
                                  .   maintaining and updating a data base on the toxicity and use of previ-
                                      ously approved food additives; and
                                  .   monitoring research on the toxicity of chemicals likely to become com-
                                      ponents of additives to ensure that purity specifications for additives
                                      are appropriate.

Colors and Cosmetics Technology       This project’s mission includes ensuring that all colors used in foods are
                                      safe for their intended use. Project activities include

                                  . performing certification analyses on manufactured batches of color
                                    additives to enforce FDA chemical specifications;
                                  . developing analytical methods and performing scientific research on
                                    colors to identify hazardous ingredients and constituents; and
                                    conducting sanitary inspections of color-manufacturing establishments
                                    to ensure that products are prepared, packed, and held in accordance
                                    with FDA regulations and good manufacturing practices, and collecting
                                    samples for evaluation.

Postmarket Surveillance and           This project’s mission is to strengthen postmarket surveillance activities
Epidemiology                          to enhance consumer protection against new and unforeseen risks with
                                      marketed products. Project activities include

                                  . performing postmarket surveillance of the safety of food ingredients,
                                    such as sulfites, aspartame, vitamins, and minerals;
                                    improving methods used to estimate human intake and exposure to
                                    foods and food components;
                                  . gathering and evaluating survey and epidemiological data on the rela-
                                    tionships between exposure to specific food components and possible
                                    adverse reactions;
                                  . performing the biennial Food Label and Packaging Survey;
                                  . performing annual consumer surveys to determine knowledge, attitudes,
                                    and buying practices concerning foods; and
                                    performing consumer surveys addressing specific health concerns.

Technical Assistance                  This project’s mission includes providing technical assistance to (1)
                                      states, in the areas of food safety at the retail level, safety and quality
                                      of shellfish, and safety and wholesomeness of domestic milk and milk


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                                 products; (2) consumers, industry, and health professionals, to aid in
                                 promoting a better awareness and understanding of food issues; and (3)
                                 foreign governments, to aid them in carrying out their food responsibili-
                                 ties. Project activities include

                             l providing national sanitation requirements for food service, food stores,
                               and food vending in the form of model codes; promoting their adoption;
                               and evaluating state programs;
                             l providing sanitation requirements for producing and processing milk
                               and milk products;
                             l administering and monitoring the Federal/State Cooperative Interstate
                               Milk Shippers Certification Program and the Dairy Safety Initiative
                               Program;
                             l conducting on-site evaluations of FDA-accredited milk laboratories
                               triennially;
                             l promoting sanitation control over all phases of shellfish growing, har-
                               vesting, processing, and marketing operations; and
                             . disseminating information about FDA'S food activities to consumers,
                               industry, and health professionals.


Center for Veterinary            The Center’s programs are designed to ensure the safety and efficacy of
                                 drugs given to and feeds eaten by animals and the safety of the food
Medicine Activities              produced from animals. The food products regulated under the Center’s
                                 programs are pet foods and livestock and poultry feeds. In 1988, the
                                 retail value of pet foods was about $6.6 billion and the retail value of
                                 livestock and poultry feeds was about $20.6 billion.

                                 Animal drug and medicated feed use is extensive. FDA estimates that
                                 about 80 percent of the livestock and poultry in the United States is
                                 treated with some animal drug or medicated feed. Also, FDA'S automated
                                 animal drug data system contains information on over 12,000 animal
                                 drug products.

                                 The Center’s two major projects are (1) Pre-Approval Evaluation of
                                 Animal Drugs and Food Additives and (2) Monitoring of Animal Drugs,
                                 Feeds, and Devices.

Pre-Approval Evaluation of       This project’s mission is to ensure that (1) new animal drugs and food
Animal Drugs and Food            additives are safe, effective, and properly compounded, formulated, and
Additives      u                 manufactured; (2) clinical and nonclinical investigations intended to
                                 demonstrate the safety or effectiveness of new animal drugs and food
                                 additives are conducted in a valid scientific manner; and (3) unapproved


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                                  animal drugs for which export is requested comply with FFDCA. Project
                                  activities include

                                developing guidelines for sponsors of new animal drugs and food
                                additives;
                                reviewing Investigational New Animal Drug and Investigational Food
                                Additive Exemptions for adequacy of food safety data, withdrawal
                                periods, and labeling;
                              . reviewing and evaluating New Animal Drug Applications and Food
                                Additive Petitions for effectiveness, animal safety, environmental
                                impact, labeling, and human food safety;
                              . reviewing medicated feed applications for formulation accuracy, ade-
                                quacy of manufacturing practices and labels, and adherence to
                                approved regulations;
                                reviewing animal drug export applications to ensure that FFJXA require-
                                ments have been met;
                                monitoring nonclinical laboratories to determine that they are in compli-
                                ance with FDA good laboratory practices regulations; and
                                monitoring clinical investigators and sponsors to ensure the quality and
                                reliability of test data submitted to FDA.

Monitoring of Animal Drugs,       The project’s mission is to ensure that (1) animal drugs, feeds, and med-
Feeds, and Devices                ical devices marketed in interstate commerce are safe and effective and
                                  are not otherwise adulterated or misbranded; (2) all medicated feeds are
                                  properly formulated, manufactured, labeled, and distributed; and (3)
                                  harmful residues do not enter the human food supply. Project activities
                                  include

                              . evaluating information submitted on approved new animal drugs and
                                initiating appropriate action to ensure that such products are safe and
                                effective or are removed from the market;
                                reviewing advertising, promotional material, and labeling of animal
                                drugs and devices in interstate commerce;
                                inspecting manufacturing and distribution facilities to ensure compli-
                                ance with New Animal Drug Applications, good manufacturing prac-
                                tices, and other FFDCA and regulatory requirements;
                              . inspecting medicated feed-manufacturing sites;
                              . collecting and analyzing samples of marketed animal drugs to determine
                                their compliance with FFLXA and removing from the market those that
                                fail to comply;
                              . collecting and analyzing animal feed samples for adulterants, such as
                                pesticides, heavy metals, naturally occurring toxicants, pathogenic
                                microorganisms, and industrial chemicals;


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                                         l   inspecting, sampling, and analyzing imported drugs to ensure compli-
                                             ance with FFDCA; and
                                         l   coordinating FDA, EPA, USDA, and state activities regarding illegal residues
                                             in animal-derived human food.


Office of Regulatory                         The Office of Regulatory Affairs consists of a headquarters staff and
                                             FDA field offices. The headquarters staff oversees field office activities.
Affairs Activities                           During fiscal year 1989, about 91 percent of the Office’s staff was
                                             located in FDA field offices. These field offices carry out inspection and
                                             enforcement activities relating to all FDA programs, including the food
                                             safety and quality programs of the Center for Food Safety and Applied
                                             Nutrition and the Center for Veterinary Medicine.

Inspection Activities                        FDA inspects food establishments for many reasons, including compli-
                                             ance with FFDCA and FDA regulations in the areas of sanitation, ingredient
                                             labeling, nutrition labeling, good manufacturing practices, low-acid
                                             canned foods, acidified foods, and food standards. The inspections can
                                             be comprehensive and cover everything under FDA'S jurisdiction or they
                                             can be directed at a specific area.

                                             About 53,000 food establishments are subject to FDA inspection. FDA
                                             inspected 9,409 food establishments in fiscal year 1986,8,343 in fiscal
                                             year 1987,7,031 in fiscal year 1988, and 6,368 in fiscal year 1989.

                                             Table 1.1 shows the number of domestic food inspections and samples
                                             analyzed by or for FDA for selected fiscal years. (Table 1.2 gives informa-
                                             tion on FDA'S import food inspections.)

Table 1 .l: Domestic Food lnspectlons
and Samples Analyzed by or for FDA for       Dollars in Millions
Selected Fiscal Years                                                                   Number of inspections
                                             Fiscal year           -~~                  FDA           State contract     Samples analyzed
                                                                                                                                      -.~
                                             1980                  -_______        16,243               -           NA                16,440
                                             1985      ~~.._.
                                                           “.__-_._-.--.-..        12,463                       11,943                23,010
                                             1988                                   8,232
                                                                                ____-_______.                    7,152                19,965
                                             1989                                   7.568                        7.766                20.098
                                             NA = Not available.
                                             Source: FDA.

Import Activities                            Under FFDCA, FDA is responsible for ensuring that imported FDA-regulated
                                             products, such as food, meet the same safety and labeling standards as



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                                        domestically produced products. The act also provides that the Secre-
                                        tary of the Treasury shall deliver to HHS, upon request, samples of
                                        imported food for examination to ensure that they comply with the act.

                                        FDA field office personnel carry out import inspections at various air-
                                        ports, seaports, and warehouses across the country. Inspections gener-
                                        ally consist of two parts: (1) a manual review of all paperwork
                                        accompanying products subject to FDA regulation to determine whether
                                        physical inspection is warranted and (2) a physical inspection of prod-
                                        ucts suspected of being either adulterated, misbranded, or both. These
                                        inspections range from wharf examinations, consisting of a quick, visual
                                        examination of products, to collecting samples for laboratory analysis.

                                        In 1988, the value of food-related imports was about $20.6 billion. The
                                        two largest categories in dollar terms were fish and fish preparations
                                        (about $6.3 billion) and fruits and vegetables (about $5.5 billion).

                                        Table 1.2 shows the number of wharf examinations conducted and sam-
                                        ples examined by FDA relating to imported food for fiscal years 1984
                                        through 1989. Wharf examinations may be conducted on products dis-
                                        charged from vessels on the wharves, in pier sheds, or at other locations
                                        or they may be conducted on products in trucks or trains at border entry
                                        points.

Table 1.2: Wharf Examinations
Conducted and Samples Examined by       Fiscal
FDA Relating to Imported Food, Fiscal   ..----- year                              Wharf examinations            Samples examined
                                        1984                                                   26,200                          19,150
Years 1984-89                           _._..
                                          - --...
                                        1985                                                   28,800                          20,600
                                        1986
                                        _.~-_-.-~~-.-_~----~                                   35,650                          26,350
                                        1987                 ._____-                           33,040                          29,890
                                        1988                                                   38.760                          32.590
                                        1989                                                   63,006                          37,570
                                        Source: FDA.


                                        Imported products that fail to meet FFDCA and FDA regulatory require-
                                        ments are considered to be violative. They are detained at import entry
                                        locations and must be exported, destroyed, reconditioned, or relabeled to
                                        bring them into compliance with federal laws and regulations. Table 1.3
                                        shows the number and type of import detentions by FDA during fiscal
                                        years 1988 and 1989.




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Table 1.3: FDA Import Detentions, Fiscal
Years 1988-89                                                                                                Fiscal year
                                           Type of detention                                        1988                            1989
                                           Food sanitation                                         9.017                            8,685
                                           Pesticide and chemical contamination                    3,821                            5,420
                                           Color/food additives                                    1,496                            1,807
                                           Food economics -                                        4.982                            3.594
                                           Total                                                  19,316                          19,506
                                           Source: FDA.




Export Activities                          FDA does not have a program specifically targeted to the safety of foods
                                           that are to be exported. However, FDA does evaluate the status of prod-
                                           ucts that are being exported because they were refused admission to the
                                           United States to determine if they comply with the export provisions of
                                           FFDCA.



Enforcement Activities                     FFDCA and FDA regulations provide FDA with authority for a variety of
                                           actions to handle violations of the act and regulations. FDA can issue
                                           written warnings to violators, request voluntary recall of violative prod-
                                           ucts, initiate seizures of violative products, seek court-ordered injunc-
                                           tions, and seek criminal prosecutions and penalties. Also, firms or
                                           individuals responsible for violative products may take voluntary cor-
                                           rective action, such as voluntarily destroying or removing the products
                                           from the market.

Written Warnings                           FDA issues two types of written warnings for violative foods-regula-
                                           tory letters and notices of adverse findings. FDA issues a regulatory
                                           letter when it concludes that a violation is serious enough to warrant
                                           immediate action, such as seizures, injunctions, or criminal penalties
                                           against firms or individuals if corrective action is not taken. FDA issues a
                                           notice of adverse findings when it concludes that a violation is not
                                           serious enough to warrant immediate action against firms or individuals
                                           but is serious enough to warrant some type of written notice. The firms
                                           or individuals are requested to provide FDA with written responses, usu-
                                           ally within 10 days for regulatory letters and 30 days for notices of
                                           adverse findings, detailing actions to correct existing violations and to
                                           prevent future violations.

                                           For foods, FDA issued 39 regulatory letters and 607 notices of adverse
                                           findings in fiscal year 1988 and 12 letters and 556 notices of adverse
                                           findings in fiscal year 1989. For animal feeds, FDA issued 52 regulatory


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                                        letters and 201 notices of adverse findings in fiscal year 1988 and 29
                                        letters and 176 notices of adverse findings in fiscal year 1989.

Voluntary Corrections and               Food-related voluntary corrections totaled 2,472 in fiscal year 1988 and
Recalls                                 2,396 in fiscal year 1989. For animal feeds, 106 occurred in fiscal year
                                        1988 and 79 in fiscal year 1989.

                                        Food product recalls totaled 470 in fiscal year 1988 and 570 in fiscal
                                        year 1989. There were 50 recalls pertaining to animals for human food
                                        use relating to the Center for Veterinary Medicine’s activities during
                                        fiscal year 1988 and 39 in fiscal year 1989.

Seizures, Injunctions, and              Adulterated or misbranded products not voluntarily destroyed or
Prosecutions                            recalled from the market may be seized by US. marshalls on orders
                                        obtained by FDA from federal district courts. Persons or firms respon-
                                        sible for violations may be prosecuted in federal courts and if found
                                        guilty, may be fined and/or imprisoned. Continued violations may be
                                        prohibited by federal court injunctions.

                                        Table 1.4 shows the number of seizures, injunctions, and prosecutions
                                        relating to food safety and quality for fiscal years 1988 and 1989.

Table 1.4: Seizure8, Injunctions, and
Prosecutions Relating to Food Safety                                                                      Fiscal year
and Quality, Fiscal Years 1988-89       Type of action                                         1988                          1989
                                        Center for Food Safety and Amlied     Nutrition
                                          Seizures                                               137                            77
                                          Prosecutions                                            14                             9
                                          Injunctions                                              3                             5
                                        Center for Veterinary Medicine
                                          Seizures                                                 3                                4
                                          Prosecutions                                             1                                1
                                          Iniunctions                                              0                                2
                                        Source: FDA




FDA’s Relationship to                   FDA pointed out that with few exceptions, FFDCAdoes not contain specific
State Inspection Programs               preemption language regarding federal versus state regulatory require-
                                        ments. Therefore, FDAneither wishes for nor is in a position of federal
                                        oversight and approval of state programs and state employees. Instead,
                                        FDAoperates in a cooperative partnership relationship with state agen-
                                        cies FDA-related state activities, whose value FDAestimated at about
                                        $175 million, are scattered among about 400 different state agencies.


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                             State activities and regulatory authorities under state acts vary greatly
                             from state to state. FDA estimated that about 70 percent of the states’
                             FDA-type activities relate to food and about 30 percent relate to other
                             FD.4programs.

                             Four FDAprograms -Cooperative Programs, State Contract Program,
                             Voluntary Work Agreement Program, and FDA Commission Program-
                             involve the use of state personnel. Descriptions of these programs
                             follow.

Cooperative Programs         According to FDA, one group of state programs for which FDA may be
                             viewed as having some oversight are the cooperative state programs. In
                             some food and drug areas, state agencies have more direct control of
                             regulatory activities. These areas include milk, shellfish, retail food
                             stores, and food service (restaurants). FDA’Srole is to provide technical
                             guidance, training, and evaluation of these state programs at the state’s
                             request through associations, such as the Interstate Conference on Milk
                             Shipments and the Interstate Shellfish Sanitation Conference. FDAsets
                             standards with the states, evaluates the states against those standards,
                             and rates state officials for their competency, familiarity with, and uni-
                             formity in applying those national standards within an individual state.
                             FDAemphasized, however, that it generally is in no position to approve
                             or disapprove a state program.

                             Through the cooperative programs, FDA, with a small investment of its
                             own resources, promotes and hopes to ensure maintenance of a uniform
                             system of state control over an inventory of about

                         l 560,000 food service establishments,
                         l 150,000 retail food stores,
                         l 1 million food vending locations,
                         . 126,000 Grade A milk farms,
                         . 770 milk pasteurization plants,
                         l 750 shellfish processors,
                         l 1,100 shellfish shippers, and
                         l 850 shellfish-growing areas.

State Contract Program       This program is designed to obtain state assistance in inspecting firms
                             that are FDA'S responsibility but that would not be covered by FDA
                             employees. The program covers a variety of areas, including food sani-
                             tation and medicated animal feeds.




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                                         In fiscal year 1989, FDA awarded 113 contracts to 45 states and Puerto
                                         Rico at a total cost of about $5.3 million. The program included such
                                         projects as investigations of pesticide residues in foods, illegal drug resi-
                                         dues in edible animal tissues, and toxins in shellfish.

Voluntary Work Agreement                 FJM has entered into agreements with state agencies to increase overall
Program                                  consumer protection through more efficient use of federal and state
                                         resources. The agreements are intended to minimize overlapping and
                                         duplicative coverage of industries regulated by both FDA and the states.
                                         The agreements are based on voluntary cooperation; they do not provide
                                         federal funds to compensate state agencies for cooperative activities.

FDA Commission Program                   FDA Commissions provide authority to 367 state and local officials to
                                         help FDA enforce FFDCA. The FDA commissioning system is designed to use
                                         the state and local officials to perform specifically designated functions
                                         that are subject to federal jurisdiction, such as to conduct examinations,
                                         inspections, and investigations, The basic reason for having the FDA
                                         Commission is that some states do not have statutory authority to con-
                                         duct inspections of some kinds of establishments in the FDA Official
                                         Establishment Inventory, to review and copy records of interstate ship-
                                         ments, or to collect product samples for FDA.


                                         FDA'S food safety and quality activities are funded through a combina-
Funding Levels                           tion of federal appropriations and reimbursements. Table 1.5 shows the
                                         amounts available for FDA'S Food and Cosmetics Program and Animal
                                         Drugs and Feeds Program and the reimbursable amounts related to
                                         foods.

Table 1.5: Amounts Available for FDA’s
Food and Cosmetics Program and           Dollars in thousands
Animal Drugs and Feeds Program for       -___-                                                            Fiscal year
Selected Fiscal Years                                                                   1980              1985              1988           1989
                                         Food and Cosmetics Programa                 $95,107          $110,541       - $126,401      $132,265
                                         Animal Drugs and Feeds
                                            Programa
                                         .--_____.-.-_____---                          19,145           23,427            25,406        26,047
                                         Total                                     $114,252          $133,968         $151,807--$158,3ti
                                         Total FDA operating
                                           arxxotxiation                            $320,720          $412.894          $476,054     $517,956
                                         Reiio~srsements related to
                                                                                         $155              $545             $176            $216
                                         %cludes fundlng for some activities not directly related to food safety and quality.
                                         Source: FDA.




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1




                                                     Table 1.6 shows the staffing levels for the Center for Food Safety and
    Staffing Levels                                  Applied Nutrition and the Center for Veterinary Medicine, and the
                                                     staffing levels relating to foods for the Office of Regulatory Affairs and
                                                     its field offices. The total staffing level decreased about 8 percent from
                                                     2,530 in fiscal year 1980 to 2,337 in fiscal year 1989. However, total
                                                     staffing levels have remained consistent from fiscal year 1985 to fiscal
                                                     year 1989.

    Table 1.6: Staffing Levels for FDA Offices
    Involved With Food Safety and Quality                                                                             Fiscal year
    Activities for Selected Fiscal Years             Organization                                    1960             1985              1988          1989
                                                                             ---
                                                     Center for Food Safety and
                                                         Applied Nutritiona
                                                     -____                                            976               859                 826         817
                                                     Center for Veterinary
                                                         Medicinea
                                                     ---__                                            238               253                 244         244
                                                     Office
                                                     .--       of___--
                                                                  Regulatory Affairs
                                                         Headquarters                                  94               106               112           114
                                                         Field
                                                     __-.__~.---__                                  1,222            1,118             1,151         1,162
                                                     Total                                          2,530            2,336             2,333         2,337
                                                     %cludes staffing for some activities not directly related to food safety and quality
                                                     Source: FDA.



                                                     During fiscal year 1989, FDA had 27 memorandums of understanding
    Coordination With                                (agreements) relating to food safety and quality with other federal agen-
    Other Federal                                    cies, primarily USDA. The agreements vary in scope, detail, and number
    Agencies                                         of agencies involved. For example, some are with one agency and are
                                                     limited in scope, such as the agreement with USDA'S Agricultural Mar-
                                                     keting Service involving aflatoxin in peanuts. Other agreements are with
                                                     several agencies and are broader in scope, such as the agreement
                                                     between FDA, EPA, and USDA concerning residues of drugs, pesticides, and
                                                     environmental contaminants in food. The following describes provisions
                                                     of the main agreements relating to the implementation of the principal
                                                     food safety and quality legislation and with whom they were made:

                                                 l   Regulatory Activities Concerning Residues of Drums, Pesticides, and
                                                     Environmental Contaminants in Food. This agreement between FDA, EPA,
                                                     AMS, and USDA'S Food Safety and Inspection Service (FSIS)establishes the
                                                     working relationships for promoting more effective, efficient, and coor-
                                                     dinated federal regulatory activities concerning residues of drugs, pesti-
                                                     cides, and environmental contaminants that may adulterate food. EPA is
                                                     to notify FDA and IJSDA of any pesticide use it encounters that may have
                                                     resulted in residues that adulterate human food or animal feed. FDA is to



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    notify EPA of possible misuse of pesticides or chemical substances that
    may indicate a violation of EPA'S laws and to notify USDA of illegal resi-
    dues of drugs, pesticides, or environmental contaminants in human food
    or animal feed which indicate that the residues may also be present in
    meat, poultry, or egg products. USDA is to notify FDA of findings of illegal
    residues in edible meat, poultry, or egg products and to keep FDAand EPA
    informed of all FSIS and AMS sampling and testing programs for illegal
    residues.
l   Inspection of Food-Manufacturing Firms. This agreement with FSIS is
    intended to minimize duplication of inspection effort by exchanging
    work-planning information and referring violative conditions concerning
    food manufacturers whose facilities are under the jurisdiction of both
    FSISand FDA. FSIS is to contact FDA whenever FSIS inspections disclose that
    products under FDA'S jurisdiction are being handled under unsanitary
    conditions or are otherwise believed to be adulterated. FDA is to do the
    same for products under IWS’jurisdiction, FDA also is to instruct its
    investigators to (1) attempt to contact any on-site FsIs inspectors on
    their arrival at a plant, (2) invite the FSISinspector to participate in the
    FDA inspection, and (3) report any adverse findings involving meat and
    poultry products to on-site FSISinspectors before leaving the plant.
l   Recall of Meat and Poultry Products. This agreement with FSIS pertains
    to meat and poultry products that have been manufactured in an FSIS-
    inspected establishment and that contain food ingredients that have
    been recalled by FDA. On learning of a recall situation, FDA is to furnish
    WIS with the rationale on which the recall is based and the identity of
    the USDA-inspectedfirms known or suspected by FDA to have received
    the food ingredients being recalled. On receiving information of a recall
    from FDA, FSSis to evaluate manufacturing procedures in consultation
    with FDA to determine the need for the secondary recall of USDA-
    inspected meat and poultry products.
l   Administration of the Egg Products Inspection Act. This agreement with
    AMS provides that AMSshall have jurisdiction (1) in official and
    exempted egg products plants; (2) in checking egg producers, packers,
    and other firms engaged in marketing eggs, including hatcheries, to
    determine the disposition of restricted eggs; and (3) over imported egg
    products. PDAshall have jurisdiction over restaurants, institutions, food-                      ‘I
    manufacturing plants, and other similar establishments that break and
    serve eggs or use them in their products. In addition, AMSis to notify FDA
    whenever it believes that shell eggs or egg products have been shipped
    in commerce in violation of the act to a receiver for which FDAhas juris-
    diction FDA is to notify AMSof any unwholesome egg products it
    encounters.



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    Food and Drug Administration  Activities
    Relating to Food Safety and Quality




. Inspecting and Sampling Dry Milk Product Plants. This agreement with
  AMS establishes procedures for coordinating the two agencies’activities
  relating to inspecting and sampling dry milk product plants to determine
  whether products are contaminated with salmonella microorganisms.
  AMS has two types of voluntary inspection programs for dry milk
  product plants. Under the Plant Inspection Program, AMS surveys plants
  for approval every 3 months. Under the Resident Inspection and
  Grading Program, a plant’s processing operation and all finished prod-
  ucts are subject to continual AMS inspection. The agreement generally
  provides that AMS will inform FDA of the plants that are under the two
  programs and the results of the salmonella tests. FDA will rely on AMS'
  salmonella surveillance program and generally will not sample for sal-
  monella the dry milk products from the plants operating under AMS'
  program.
l Inspection and Grading of Food Products. This agreement with AMS per-
  tains to the agencies’inspection and standardization activities for food
  products, including fruits and vegetables. AMS is to provide FDA a list of
  the food processing and packaging plants operating under AMS continual
  or other resident-type inspection/grading contracts and to notify FDA
  whenever AMS terminates or denies inspection services at a plant
  because of sanitation or other current good manufacturing practice defi-
  ciencies. FDA is to invite the AMS inspector stationed at a plant to accom-
  pany the FDA inspector during the FDA inspection. FDA also is to
  immediately notify the appropriate AMS field office whenever FDA finds
  objectionable conditions in plants where AMS is conducting inspections
  and in other plants when FDA believes the information would be valuable
    to AMS.
l Inspection and Standardization of Grain, Rice, Pulses, and Food Prod-
  ucts. This agreement with USDA'S Federal Grain Inspection Service (FGIS)
  pertains to the inspection of facilities that process, hold, and distribute
  grain, rice, pulses, and similar food products. When FDA is inspecting a
  facility where an FGIS inspector or licensee is stationed, FDA is to request
  the FGIS representative to accompany the FDA inspector during the
  inspection. FGIS is to promptly notify FDA of facilities that are subject to
  withdrawal or suspension of service, termination of contract, or denial
  of official FGIS services because of unsanitary conditions or other
  processing deficiencies. Each agency is to notify the other of serious
  objectionable conditions found during inspections.
. Inspection of Fishery Products. An FDA memorandum of understanding
  with the National Marine Fisheries Service (NMFS), Department of Com-
  merce, covers fishery products plants that are under NMFS voluntary




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                          Food and Drug Adminbtration   Activities
                          Relating to Food Safety and Quality




                          inspection contracts and also subject to FDA inspection, The memo-
                          randum provides that NMFS is to apply to plants and products under vol-
                          untary NMFS inspection appropriate FDA requirements pertaining to good
                          manufacturing practices, labeling, food additives, tolerances, standards
                          of identity, minimum quality, and fill of container. NMFSis to notify FDA
                          if inspections reveal violations of mandatory FDA requirements, and FDA
                          is to notify NMFS of any official seizure actions taken by FDA regarding
                          fishery products processed or packed in NMFs-inspectedplants.


                          Both the Center for Food Safety and Applied Nutrition and the Center
Critical Food Safety      for Veterinary Medicine provided information on critical food safety
and Quality Issues        and quality issues of the 1990s The following issues are among those
Facing FDA During the     cited by the Center for Food Safety and Applied Nutrition:
1990s                 . The safety of foods produced by biotechnology and other novel means.
                      . Policies and programs for the microbial safety of foods, including the
                        implications of increasing the ease and sensitivity of pathogen detection.
                      . Policies and programs for monitoring the food supply, including the
                        proper balance of surveillance and inspection activities.
                      . The agency’s role in educating the public about food quality and safety,
                        including the issues of food labeling, nutrition labeling, and dietary
                        advice to high-risk groups.
                      . The use of appropriate regulatory tools, including the application of
                        food standards and food labeling to include warning labeling.

                          The Center also set out various groups’ roles in meeting future chal-
                          lenges as follows:

                      .   FDA'S role includes providing for a network among the various food-
                        related organizations to allow for a broad-based and timely exchange of
                        information on food programs.
                      . The private sector’s and consumers’ roles include ensuring that open
                        communication is maintained that allows for a meaningful exchange of
                        information on food safety and quality policy and program issues.
                      . The executive branch’s role includes consultation with executive branch
                        organizations to ensure that proper roles are established and that
                        efforts are effective and not duplicative.
                      . Congress’role includes granting FDA authority to access records kept by
                        food firms and consideration of additional surveillance authority to aug-
                        ment current inspection authority.




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                                                                          1
Food md Drug Admhbtrrtbn   Activities~
Rdathgto FoodSafetyandQuaUty




The Center for Veterinary Medicine provided the following list of crit-
ical food safety and quality issuesof the 1990s:
Mycotoxin (a toxic substanceproduced by a fungus) contamination of
grains and other feedstuffs and the control proceduresused.
Pesticide and industrial chemical contamination of feeds and feed
ingredients.
Microbiological contamination of feed ingredients and the control proce-
dures used.
Feed and drug products produced using biotechnology.
The by-product feed ingredient industry, especially industrial wastes
used as feed ingredients.
Product labeling, particularly pet food labeling, as it affects animal
health and product quality.
Drug and chemical residuesin meat, milk, and eggs.
Drugs and additives used in commercial finfish and shellfish.




Pege   a4                   GAO/RCED-Ql-19B   Federal Food Safety and Quality   Programs
Ehvironmental Protection Agency Activities
Relating to Pesticide Regulation and
Tolermce Levels
                    The Environmental Protection Agency is responsible for regulating all
                    pesticide products sold or distributed in the United States and for estab-
                    lishing tolerances (maximum legal limits) for pesticide residues in or on
                    food commodities and animal feed.

                    About 815 million pounds of pesticide-active ingredients-those that
                    destroy or control pests- are used annually in U.S. agriculture. Also,
                    virtually all end-use pesticide products also contain one or more inert
                    ingredients-those that propel, dilute, or stabilize the active ingredi-
                    ents-which may also be toxic and pose a food safety risk. About 1,200
                    inert ingredients are accepted for use in pesticide products, of which
                    about 600 are accepted for use in food-use pesticide products.


                    EPA’S food safety activities are conducted pursuant to two principal
Major Legislation   laws-the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
                    amended (7 U.S.C. 136 et seq.), and FFDCA, as amended (21 U.S.C. 301 et
                                                                                         -
                    seq.).

                    Under FIFIIA, EPA is required to register pesticide products, specify the
                    terms and conditions of their use prior to being marketed, and remove
                    unreasonably hazardous pesticides from the marketplace. EPA is respon-
                    sible for ensuring that when pesticides are used according to directions,
                    they will not present unreasonable risks to human health or the environ-
                    ment. The act requires EPA to take into account the economic, social, and
                    environmental costs and benefits in making decisions.

                    IJnder FIFKA amendments in 1972, the Congress mandated that EPA
                    assessthe safety of all pesticide products that had been previously reg-
                    istered by federal and state governments. The Congress required that
                    WA reregister these pesticides using current health and environmental
                    protection criteria because the data bases supporting these older pesti-
                    cide registrations were incomplete or inadequate by present scientific
                    standards. Further amendments in 1978 and 1988 were aimed at expe-
                    diting reregistration and improving data availability.

                    IJnder PE’DW,EPA is responsible for setting maximum allowed residue
                    levels, or tolerances, for pesticide residues on food commodities and
                    animal feed marketed in the United States. If a pesticide is being consid-
                    ered for use on a food or feed crop, the applicant must petition EPA for a
                    tolerance and submit appropriate data so that EPA can define a safe and
                    realistic tolerance level or grant an exemption from the tolerance
                    requirement, Tolerances apply to imported commodities as well as


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                       Part2
                       Environn~ental Protection Agency Activities
                       ReWng to Pesticide Regulation and
                       Tolerance Levela




                       domestically produced food commodities and animal feed. The tolerance
                       program’s purpose is to ensure that U.S. consumers are not exposed to
                       unsafe pesticide residue levels. Under the act, a food product is adulter-
                       ated if it contains residues of a pesticide for which a tolerance has not
                       been established or it contains residues exceeding the established
                       tolerance.

                       EPA also administers the Toxic Substances Control Act (15 U.S.C. 2601 et
                       seq.) under which it controls the manufacturing, processing, distribu- -
                       tion, use, and disposal of chemical substances and mixtures, including
                       those that can adulterate food.


                       The Office of Pesticide Programs (OPP), a part of EPA’S Office of Pesti-
Organizational Units   tides and Toxic Substances, is responsible for the overall management
and Responsibilities   of EPA’S pesticide regulatory responsibilities under FIFRA and FFDCA.

                       OPP has six divisions involved with the safety of pesticides: (1) Registra-
                       tion, (2) Special Review and Reregistration, (3) Health Effects, (4) Envi-
                       ronmental Fate and Effects, (5) Biological and Economic Analysis, and
                       (6) Field Operations.

                       The Registration Division registers new pesticide products and new uses
                       and/or new formulations of currently registered products, establishes
                       tolerances or exemptions from tolerance, and revokes tolerances.

                       The Special Review and Reregistration Division manages the special
                       review process, the reregistration of active ingredients in pesticide prod-
                       ucts, and the data call-in process under which EPA requires pesticide pro-
                       ducers to provide certain data derived from studies.

                       The Health Effects Division reviews, evaluates, and validates all data
                       submitted on the toxicological effects on humans and animals and
                       potential exposure to pesticides, The Division develops risk assessments
                       on proposed and existing pesticide uses to support registration, special
                       review, reregistration, and tolerance decisions. This includes assessing
                       potential dietary exposures to pesticides in support of EPA decisions.

                       The Environmental Fate and Effects Division reviews data on pesticides’
                       effects on biological species (other than humans and domestic animals)
                       and pesticides’ fate in the environment. The Division performs risk
                       assessments on pesticide uses and oversees OPP’S efforts in the areas of



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                             Envhnmentnl     Protection Agency Actlvlties
                             Relating to Pesticide Wgulation and
                             Tolerance Levels




                             biotechnology, groundwater protection, pesticide monitoring, quality
                             assurance, pesticide disposal, and endangered species protection.

                             The Biological and Economic Analysis Division conducts analyses on
                             pesticide use and benefits; acquires, validates, and interprets technical
                             data on pesticide use; and performs economic analyses on the quality
                             and yield impacts of EPA regulatory programs. The Division also
                             develops scientific data on pesticide use patterns in support of exposure
                             assessments and provides analytical laboratory capability by validating
                             residue tolerance methods.

                             The Field Operations Division communicates OPP'S regulatory actions,
                             policies, and programs in the field. This includes interacting with EPA
                             regions, OPP'S state regulatory counterparts, the public, pesticide users
                             and other interest groups, USDA, and other external institutions.


                             Food safety is not a unique program element within OPP. However, OPP'S
Program Activities           activities and programs- such as registering new pesticides, reregis-
                             tering existing pesticides, establishing pesticide tolerances, and con-
                             ducting special reviews of pesticides of concern-contribute to and
                             promote food safety and quality. For example, registration of new pesti-
                             cide products enhances food safety as newer and safer pesticides are
                             allowed to enter the market and replace older, less scientifically
                             advanced products. Also, OPP'S activities relating to pesticide tolerances
                             clearly are related to food safety. And reregistration of pesticide prod-
                             ucts enables EPA to review pesticide products being used in the United
                             States and ensure that proper action is taken to eliminate unsafe chemi-
                             cals from the market.

Registering New Pesticides   Under FIFRA, EPA is responsible for registering specified uses of pesticide
                             products on the basis of both safety and benefits. EPA can register a pes-
                             ticide only if it determines that the pesticide will perform its intended
                             function without causing any unreasonable risk to humans or the envi-
                             ronment, taking into account the economic, social, and environmental
                             costs and benefits of the pesticide’s use.

                             EPA generally must register a pesticide product before it may be sold or
                             distributed in either intrastate or interstate commerce. Registrations are
                             basically licenses for specified uses of pesticide products. A pesticide
                             product registration sets the terms and conditions of that product’s use.
                             EPA requires pesticide registrants to label their products as a primary
                             means to regulate risks to people and the environment. For example, EPA


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                                      Part2
                                      Environmental   Protection Agency Activities
                                      Relating to Pesticide Regulation and
                                      Tolerance Levels




                                      may require that labels provide precautionary statements that restrict
                                      the use of a pesticide to trained and certified applicators.

                                      EPA also permits certain limited uses of unregistered pesticides for
                                      experimentation to generate data for supporting registration and
                                      addressing emergency pest situations.

                                      In addition, a pesticide produced solely for export is not required to be
                                      registered with EPA and may be exported regardless of its U.S. regula-
                                      tory status, subject to certain labeling, reporting, and notification
                                      requirements.

                                      EPA requires health and environmental effects data and information
                                      from pesticide producers so it can evaluate the risks and benefits of pes-
                                      ticides and make regulatory judgments about the safety of each pesti-
                                      cide proposed for use. These data relate to such information as the
                                      potential for inducing adverse health effects and the quantity and
                                      nature of residues likely to occur in food or feed crops.

                                      OPP registered 14 new chemicals for the first time under FIFJU in cal-
                                      endar year 1989. This compared with 11 each in calendar years 1987
                                      and 1988.

l&registering   Existing Pesticides   In 1978, the Congress required EPA to expedite the reregistration pro-
                                      cess, mandated under the 1972 FIFRA amendments, giving priority to pes-
                                      ticides used on food and other uses which present potentially high
                                      exposures. To help expedite reregistration, EPA established the Registra-
                                      tion Standards process in 1980. A Registration Standard states EPA'S
                                      evaluation of existing data and identifies incomplete or additional data
                                      requirements that registrants must fulfill to reregister a pesticide
                                      product. The process’aim is to reevaluate the active ingredients in pesti-
                                      cide products in accordance with new standards for registration. As of
                                      December 1989, EPA had issued 197 Registration Standards under its
                                      Reregistration Program.

                                      To obtain data needed to prepare Registration Standards, EPA initiated
                                      the data call-in process in 198 1. Under this process, EPA sends letters to
                                      registrants identifying the testing needs and requires the initiation of
                                      such studies. EPA also sets deadlines for completing the studies. By the
                                      end of fiscal year 1985, EPA had completed calling in chronic toxicity
                                      data for all pesticides applied to food crops.




                                      Page 38                          GAO/RCED-Bl-1BB   Federal Food Safety and Quality   Programs
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                                    Environmental   Protection Agency Activities
                                    Relating to Pesticide IbqulatIon and
                                    Tolerance Levels




                                    The 1988 FIFRA amendments mandated a comprehensive data call-in and
                                    accelerated reregistration process to be implemented over a Q-year
                                    period. This mandate covers about 600 cases (or 1,100 active ingredi-
                                    ents) appearing in about 26,000 different pesticide products.

Establishing Pesticide Tolerances   If a pesticide is being considered for use on a food or feed crop, the
                                    applicant must petition EPA for a tolerance and submit appropriate data
                                    so that EPA can define a safe and realistic tolerance level. These data
                                    include information on the pesticide’s toxicity (potential to cause
                                    adverse health effects), the residues that may remain in or on food or
                                    feed, and an analytical method that can detect the chemical and any
                                    metabolites of concern in the commodity.

                                    Tolerances are the maximum acceptable levels of pesticide residues that
                                    may remain in or on food commodities and animal feed as a result of
                                    applying a pesticide. Tolerances are aimed at protecting human health
                                    while allowing for the production of an adequate, wholesome, and eco-
                                    nomical food supply. At the request of FDA or USDA, EPA also sometimes
                                    recommends enforcement levels (action levels) for residues occurring in
                                    food commodities and animal feed for reasons other than the direct
                                    application of a pesticide. For example, EPA can recommend to FDA and
                                    USDAan action level for residues occurring in food commodities from a
                                    pesticide whose registration has been cancelled by EPA but which per-
                                    sists in the environment.

                                    FDA, USDA, and state enforcement agencies are responsible for enforcing
                                    tolerances. USDA has monitoring and enforcement responsibilities for
                                    pesticide residues in meat, poultry, and egg products. FDA is responsible
                                    for monitoring the rest of the nation’s food supply. These agencies test
                                    samples of food to determine if the food contains residues for which no
                                    tolerance has been set or residues exceeding tolerance levels, rendering
                                    the food adulterated. Food commodities with residues in excess of toler-
                                    ance levels or residues for which no tolerance has been set are subject to
                                    seizure.

Conducting Special Reviews of       Whenever data on a registered pesticide raise concern about a health or
Pesticides of Concern               environmental risk, EPA can conduct a detailed risk/benefit analysis
                                    under its special review process.This processallows all interested par-
                                    ties to submit to EPA information concerning the pesticide’s risks and
                                    benefits. At the conclusion of a special review, EPA may decide to con-
                                    tinue, restrict, or cancel some or all uses of the pesticide under
                                    consideration.



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                        Tolerance Level




                        EPA began conducting special reviews in 1975. As of December 1989,
                        selected special review process accomplishments relating to all types of
                        pesticides, including those that show up as residues in food, are as
                        follows:

                        Thirty-six chemicals received special review final determinations.
                        Eighteen chemicals were returned to the registration process after a pre-
                        special review determination.
                        Registrations for seven chemicals were cancelled before the special
                        review process.
                        Registrations for 28 chemicals were voluntarily cancelled as a result of
                        the special review process.
                        Fourteen chemicals were in the special review process.

Relationship to State   The 1978 FIFRA amendments gave states (including American Samoa, the
Enforcement Programs    District of Columbia, Guam, Puerto Rico, Trust Territory of the Pacific
                        Islands, and Virgin Islands) primary enforcement responsibility for pes-
                        ticide use violations. FIFRA authorizes EPA to enter into cooperative
                        agreements with states and Indian tribes for pesticide enforcement and
                        to train and certify pesticide applicators.

                        EPA has cooperative agreements with states, territories, and Indian
                        tribes to perform enforcement activities, and it oversees the manage-
                        ment of nonfederal enforcement programs. The participating entities
                        conduct use inspections, inspect pesticide-producing establishments,
                        maintain marketplace surveillance, inspect imports, and inspect dealers
                        and users of restricted-use pesticides. They also complete analyses of
                        pesticide samples collected during inspections. In most instances, they
                        develop enforcement cases and issue enforcement actions when viola-
                        tions are detected. In a limited number of instances, they refer cases to
                        EPAfor action.

                        During fiscal year 1989, EPA had enforcement agreements with all states
                        (except Colorado, Nebraska, and Wyoming in terms of private applica-
                        tors), the District of Columbia, Puerto Rico, 5 territories, and 8 enforce-
                        ment grants with 14 Indian tribes. In the nonparticipating states, EPA
                        sets FIFI~A enforcement policy and conducts compliance monitoring and
                        enforcement programs. In fiscal year 1989, EPA obligated a total of about
                        $8.8 million for pesticide enforcement grants. Table 2.1 shows selected
                        enforcement activity data for states, territories, and Indian tribes oper-
                        ating under enforcement cooperative agreements for fiscal years 1988
                        through 1990.



                        Page 40                           GAO/RCED-91-19B   Federal Food Safety and Quality   Programs
                                         Part2
                                         Environmental   Protection Agency Activities
                                         Relating to Peeticide Regulation and
                                         Tolerance Levels




Table 2.1: Selected Pesticide
Enforcement Activity Data for States,                                                                     Fiscal year
Territories, and Indian Tribes, Fiscal   Activity                                                  1988           1989         1990 (est.)
                                         -_-____---.._-_-_-.-      --.~...--_--...
Years 1988-90                            Use                                                     12,639          19,308            18,829
                                         --___-inspections       ---__                                                               __
                                         Producer establishment inspections                       1,488           1,662             2,509
                                         Marketplace inspections                                  5,662           8,032             4,035
                                         Import inspections                                         273             431               475
                                         Source: EPA


                                         Cooperative agreements with states, territories, and Indian tribes to cer-
                                         tify and train applicators who use restricted use pesticides are set up
                                         under the cooperative program called Pesticides Program Implementa-
                                         tion. In fiscal year 1989, EPA obligated a total of about $4.97 million for
                                         this program, including $3.98 million for the program’s grant portion.


                                         OPP activities are funded primarily by federal appropriations. Since
Funding Levels                           implementation of the 1988 FIFRA amendments, which established a sep-
                                         arate reregistration fee system, the Reregistration and Expedited
                                         Processing Re crolving Fund (FIFRA Revolving Fund) has also provided
                                         resources. In fiscal year 1989, about 90 percent of OPP’S $54.7 million
                                         funds (excluding funds for disposal of suspended or cancelled pesti-
                                         cides) were federal funds, with the remaining 10 percent charged to
                                         revolving funds-$5.2 million from the FIFRA Revolving Fund and $1
                                         million from the Tolerance Revolving Fund.

                                         Table 2.2 shows OPP’S actual obligations for fiscal years 1980 through
                                         1989, excluding funds for disposal of suspended or cancelled pesticides.
                                         For comparison purposes, special funding of $7.4 million for fiscal year
                                         1988 and $41.3 million for fiscal year 1989 for disposal of suspended
                                         and cancelled pesticides was not included in the table since the funds
                                         were for a special purpose and were available only for fiscal years 1988
                                         and 1989. The Generic Chemical Review Program includes funding for
                                         ~1~~‘sreregistration and special review activities.




                                         Page 41                            GAO/RCED91-19B   Federal Food Safety and Quality    Programs
                                             Part.2
                                             JSnvlroxunental Protection Agency Activiti~
                                             Relsting to Peetlclde Regulation       and
                                             Tolerance Iavele




Table 2.2: EPA/OPP Obliaatiotw, Fiscal Year8 1980-89
Dollars in Millions
                                                                                                Fiscal year
Program                                          1980       1981        1982        1983        1984     1985      1986     1987      1988       1989
&xieric       Chemical     Review                $28.2      $28.1       $22.1       $20.0       $20.4    $24.2    $23.5     $25.1     $27.4     $33.1"
Registration
I                             ~.                      6.9     8.4         8.2         7.8         9.9     14.9     12.7      12.6      11.8      16.2
Specral Reaistration                                  2.2     2.5         1.9         2.6         2.7      2.1      1.9       1.9       2.0                b
          .        .          ~~~.
                                                                                                                                                           b
Tolerances                                            2.2      2.1         2.1         2.1         2.5      3.2      2.7      2.6      2.9
Labcratory       Support                                .           .           .           .       .l       .3       .2       .3        .2           .i
Pesticide      Program     lmplementationC
                                .._~_                                                                                                  4.6           5.0
Total                                           $39.:       $41.;       $34.;       $32.;       $35.;    $44.;    $41.0'   $42.;     $48.9      $54.7
                                             Note: Columns may not add to totals because of rounding.
                                             %cludes $5.2 million charged to the FIFRA Revolving Fund.
                                             bBeginning in fiscal year 1989, resources for Registration, Special Registration, and Tolerances were
                                             merged into the Registration program element.
                                             ‘Beginning in fiscal year 1988, the Pesticide Program Implementation program element was transferred
                                             from EPA’s Office of Compliance Monitoring to OPP.
                                             Source: EPA.



                                             During fiscal year 1989, OPP maintained a headquarters staff in
Staffing Levels                              Arlington, Virginia, and supported certification and training staff in EPA
                                             regions. In fiscal year 1989, about 97 percent (604) of OPP’S total full-
                                             time equivalent staffing of 624 were in headquarters, with the
                                             remaining 3 percent allocated to regional offices. Table 2.3 shows OPP’S
                                             full-time equivalent staffing levels for fiscal years 1980 through 1989.




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                                            Part2
                                            Environmental   Protection Agency Activities
                                            Relating to Pesticide Regulation and
                                            Tolerance Levels




Table 2.3: EPA/OPP Full-lime Equivalent Staffing Levels, Fiscal Years 1980-89
                                                                                           Fiscal year
Program                                         1980       1981      1982       1983       1984     1985        1988       1987      1988       1989
Generic Chemical Review                           354        304       221        193       208         250       272       272        307       338a
Registration                                      243        231       214        193       220       - 218       195       195        166     ___264
Special Registration                               80         66        51         63        61          45        41        39         43                b

Tolerances                                         78         76        82         76        66          78        72        69         71                b

Pesticide Program lmplementationC                    .         .          .          .         .          .         .          .      --_2
                                                                                                                                         15
                                                                                                                                      .-____
Total                                             755       677        568        525       555        591       580        575        602          624
                                            %cludes 31 full-time equivalent staffing funded by the FIFRA Revolving Fund.
                                            ‘Beginning in fiscal year 1989, resources for Registration, Special Registration, and Tolerances were
                                            merged Into the Registration program element.

                                            ‘Beginning in fiscal year 1988, the Pesticide Program Implementation program element was transferred
                                            from EPA’s Office of Compliance Monitoring to OPP.
                                            Source: EPA.



                                            To coordinate its food safety activities with other federal agencies, EPA
Coordination With                           had four written memorandums of understanding, as follows, with FDA
Other Federal                               and/or IJSDA:
Agencies                                . Regulatory Activities Concerning Residues of Drugs, Pesticides, and
                                          Environmental Contaminants in Food. This agreement between EPA, FDA,
                                          and USDA is described in part 1.
                                        . Responsibilities Under FFDCA and FIFRA. This agreement with FDA pro-
                                          vides for coordination of activities pertaining to pesticide chemical prod-
                                          ucts subject to the requirements of both FFDCAand FIFRA. The agreement
                                          specifies the types of petitions or applications that will be processed by
                                          each agency and provides for notifying product manufacturers of which
                                          agency has primary jurisdiction over the product.
                                        . Pesticide Benefit/Risk Assessments. This agreement between EPA and
                                          IJSDA establishes procedures for coordinating the two agencies’activities
                                          relating to evaluating the benefits and risks of pesticides subject to regu-
                                          latory decisions under FIFRA. The agreement implements a FIFRA provi-
                                          sion that requires EPA to notify USDA of EPA regulatory proposals that
                                          affect agriculture. IJSDA may comment on the proposals and related anal-
                                          yses of agricultural impact before the proposals are finalized.
                                        . Training Pesticide Applicators. This agreement with USDA'S Extension
                                          Service provides for coordination in providing training to restricted-use
                                          pesticide applicators through State Cooperative Extension Services’
                                          programs.



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                          Part2
                          Environmental   Protection Agency Activities
                          Relating to Pesticide Regulation and
                          Tolerance Levels




                          According to EPA, most of the critical pesticide food safety and quality
Critical Food Safety      issues of the 1990s are addressed in the proposed changes in FIFRA and
and Quality Issues        FFDCA contained in President Bush’s October 1989 Food Safety Plan. The
Facing EPA During the     Plan, which was developed with the assistance of EPA, USDA, and HHS, is
                          intended to improve the federal government’s ability to protect Amer-
1990s                     ican consumers and the environment from potential dangers posed by
                          the use of pesticide chemicals. The Plan’s key points are discussed
                          below.


Streamlined FIFRA         Under FIFRA, EPA can cancel a pesticide registration if it determines that
Cancellation Procedures   the pesticide’s use causes unreasonable adverse effects to human health
                          or the environment. However, cancellation currently can take 4 to 8
                          years to complete, because of extensive information gathering by EPA
                          and provisions in the law for challenging EPA decisions.

                          Under the President’s Plan, the cancellation process would be shortened
                          by about half by eliminating the formal adjudicatory hearing and substi-
                          tuting a notice and comment procedure. An informal hearing may be
                          held during the comment period, and EPA'S final decision could be chal-
                          lenged in federal courts.


Improved Suspension       Because the pesticide cancellation process takes a long time, FIFRA allows
                          EPA to suspend pesticides during the cancellation process under certain
Authority Under FIFRA     circumstances. According to EPA, the current FIFRA suspension standards
                          have proven difficult to implement and have prevented EPA from
                          removing pesticides from the market in a timely manner when substan-
                          tial safety questions exist.

                          The President’s Plan proposes redefining the standard for “imminent
                          hazard” suspensions to provide EPA greater flexibility in using its sus-
                          pension authority. The Plan provides that when the risk associated with
                          a pesticide is high, EPA may order a suspension without considering the
                          pesticide’s economic benefits and without a hearing. When the risk may
                          be lower or there is greater uncertainty, EPA may order a suspension
                          after some consideration of the impact on food prices and availability.


Periodic Reregistration   The 1988 FIFRA amendments require that pesticides first registered
Review      ”             before 1984 undergo accelerated reregistration to bring the data bases
                          supporting their use up to current scientific standards. Accelerated



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                       Environmental   Protection Agency Activitiee
                       Relating to Peeticide Regulation end
                       Tolerance Levels




                       reregistration is underway, but it covers only those chemicals first regis-
                       tered prior to 1984, and it constitutes only a one-time catch-up to cur-
                       rent standards for those pesticides. According to EPA, once the process is
                       completed and time passes, EPA could find itself in a situation once again
                       in which updated scientific data and current reviews are needed.

                       The President’s Plan establishes the principle of an ongoing data-genera-
                       tion and review process for all pesticides, regardless of when they were
                       first registered. Pesticide registrants would be on notice that they will be
                       required to supply EPA with data on a predictable schedule, allowing EPA
                       to determine whether pesticides meet up-to-date standards for registra-
                       tion. The new process is intended to avoid any future need for massive
                       catch-up reregistration efforts while affording the public assurance that
                       the data bases supporting pesticide registrations are being kept current
                       with evolving scientific standards.


Enhanced Enforcement   According to EPA, the current FWRAis one of the weakest environmental
                       protection statutes in terms of the penalties that can be assessed for sig-
                       nificant violations. The maximum civil fine is $5,000 per violation and
                       applies only to persons who sell, distribute, or commercially use pesti-
                       cides. Other persons who violate FIFRA may be assessed a civil penalty of
                       up to $1,000. In addition, no major changes have been made in the dollar
                       amount of civil fines since 1972-18 years ago-and the statute’s crim-
                       inal violations are considered misdemeanors, regardless of the serious-
                       ness of the crime.

                       EPA stated that current record-keeping and information-gathering
                       authority is also limited. And inspection authority is limited to places
                       where pesticides are held for sale or distribution or places where any
                       suspended or cancelled pesticides are held. This leaves EPA without spe-
                       cific authority to inspect certain persons who are subject to existing
                       requirements under FIFF~A.

                       The President’s Plan proposes to bring FIFRA in line with other major
                       environmental statutes. Penalties would be increased for persons who
                       sell, distribute, and commercially use pesticides in violation of the law to
                       a maximum of $25,000 per day per violation. Criminal violations would
                       be raised from misdemeanors to felonies. Also, the proposal would
                       extend the authority to require records to most persons involved in
                       selling or distributing pesticides, applying pesticides for hire, applying
                       restricted-use pesticides, and pesticide-testing facilities. The inspection



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                             Part 2
                             Enviroumental   Protection Agency Activities
                             Relating to Pesticide Regulation and
                             Tolerance Levels




                             authority would also be expanded to testing facilities, persons who com-
                             mercially apply pesticides, and any place where there is reason to
                             believe FIFRA has been or is being violated.

----_.-   -I-...-.-_-.-_.
Compatibility of Pesticide   According to EPA, current law has inconsistent provisions relating to
                             food tolerances. Section 408 of FFDCA requires that EPA give appropriate
Tolerances                   consideration to the need for producing an adequate, wholesome, and
                             economical food supply. FIFRA also directs EPA to balance the risks and
                             benefits of a pesticide’s use. However, the Delaney clause of Section 409
                             of FFDCA, which applies to processed food products, states that no addi-
                             tive shall be deemed safe if it is found to induce cancer when ingested
                             by man or animal. If a strict, literal interpretation is given to this clause,
                             it bars EPA from setting a food additive regulation for certain foods
                             which may be processed if there is any evidence of a cancer risk in high-
                             dose animal studies, no matter how small the risk or how large the
                             benefits.

                             The President’s Plan proposes to replace the Delaney clause with a con-
                             sistent negligible risk standard for all pesticide tolerances posing a carci-
                             nogenic risk on both raw and processed foods.


lJniform Tolerances          IJnder current law, states may set tolerances for pesticide residues in
                             food that are lower than those established by EPA. According to EPA, this
                             situation creates the potential for considerable consumer confusion and
                             substantial disruption of interstate commerce in food products. Inconsis-
                             tent tolerances could also complicate international trade in raw agricul-
                             tural commodities and processed foods.

                             The President’s Plan proposes that national uniformity be established
                             by statute for tolerances that are set as a result of EPA'S ongoing reregis-
                             tration efforts and for new pesticides that are reviewed under the
                             revised standards described in the Plan. States would still be able to
                             obtain waivers and establish their own tolerances if special local circum-
                             stances exist.


Consultation Within the      Current consultation between EPA, IMS, and USDA primarily occurs in the
                             form of written comment during the cancellation process. For example,
Federal Government
            ”                FIFKArequires EPAto provide USDA an opportunity to comment on pro-
                             posed notices of intent to cancel a pesticide’s registration, and EPA



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Fhwironmental Protmtion Agency Actititiw
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Tolerance Leveb




addressesany USI&commentswhen EPA issuesa final notice of intent to
cancel.
The President’sPlan would require appropriate consultation between
EPA, HI-& and USIIAbefore issuing cancellation and suspensionorders and
at such other times as they may agreeto.




Page 47                        GAO/RCED-91.19B   Federal Food Safety and Quality   Pmgrama
Part 3

Food Safety and Inspection Service Activities
Relating to Meat and Poultry Safety and Quality

                        USDA's Food Safety and Inspection Service administers a comprehensive
                        system of inspection laws to ensure that meat and poultry products
                        moving in interstate and foreign commerce for use in our food supply
                        are safe, wholesome, and correctly marked, labeled, and packaged.


                        FSIScarries out its meat and poultry inspection responsibilities under the
Major Legislation       Federal Meat Inspection Act, as amended (21 U.S.C. 601 et seq.) and the
                        Poultry Products Inspection Act, as amended (21 U.S.C. 451 et seq.).

                        The first major amendment to the Federal Meat Inspection Act-the
                        Wholesome Meat Act-was passed in 1967. It established the federal-
                        state cooperative program under which USDA helps fund state inspection
                        programs. It also required state inspection programs to be “at least
                        equal to” the federal program and strengthened the regulation of
                        imported meat. The Wholesome Poultry Products Act of 1968 extended
                        the same provisions to poultry inspection.

                        In 1986, the Congress enacted discretionary inspection authority permit-
                        ting FSISto vary the type of inspection in processing plants depending on
                        the product, the plant’s compliance history, and the commitment of
                        plant management to control its operation. Discretionary inspection
                        authority expires in 1992 unless extended by the Congress.

                        Another act affecting FSIS activities is the Talmadge-Aiken Act of 1962
                        (7 U.S.C. 450 et seq.). The act established cooperative agreements per-
                        mitting state employees to carry out inspection in meat and poultry
                        slaughtering and processing plants. These plants are considered to be
                        “federally inspected” and thus may sell their products in interstate
                        commerce.


                        The four major IBIS organizational units that are directly involved with
Organizational Units    inspection and supportive activities are Inspection Operations, Regula-
and Responsibilities    tory Programs, International Programs, and Science and Technology.
                        Their responsibilities are described below.


Inspection Operations   The Inspection Operations unit is responsible for inspecting and moni-
                        toring operations in about 6,720 meat and poultry plants throughout the
            ”           United States and 220 official import establishments to ensure that con-
                        sumers receive safe, wholesome, and accurately labeled products.



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                         Food Safety and Inspection Service Activities
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                         and Quality




                         IWS inspection activities are carried out by a network of 5 regional
                         offices, 26 area offices, and about 200 inspection circuits. Each region is
                         managed by a regional director, who reports to the Assistant Deputy
                         Administrator of Regional Operations. Each of the five or six area
                         offices in each region is managed by an area supervisor, who reports to
                         the regional director. Within each area are several inspection circuits,
                         each managed by a circuit supervisor. Circuit supervisors oversee the
                         inspectors-in-charge of the plants within their circuits.


Regulatory Programs      The Regulatory Programs unit is responsible for managing IWS’ label
                         approval and food ingredient assessment activities, investigating statu-
                         tory violations, initiating appropriate sanctions, and conducting over-
                         sight reviews over agency programs and operations.


International Programs   The International Programs unit is responsible for ensuring that
                         imported meat and poultry products are produced under the control of
                         inspection systems that are equivalent to the U.S. system and that the
                         products are wholesome and correctly labeled. It also supports U.S.
                         exports through technical discussions of foreign inspection require-
                         ments, dissemination of export information, and certification that
                         exported products meet U.S. and foreign requirements.


Science and Technology   The Science and Technology unit is responsible for providing the scien-
                         tific services and technical support necessary to advance meat and
                         poultry inspection beyond detection and toward the prevention of food-
                         borne hazards while relying heavily on risk assessment and quality con-
                         trol. Its support services are designed to assure product safety from
                         disease, harmful chemicals, toxins, and food-poisoning microorganisms,
                         as well as to prevent economic fraud and unsanitary preparation.

                         The Science and Technology unit maintains laboratories in Athens,
                         Georgia; Alameda, California; and St. Louis, Missouri, to provide analyt-
                         ical support for FSIS activities. It augments the analytical capacity of
                         these laboratories by contracting with nonfederal laboratories.


                         ISIS’ major activities, which are described below, range from setting and
Program Activities       reviewing compliance with plant sanitation standards to monitoring
                         state inspection programs and reinspecting imported meat and poultry
                         products.


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                             Faod Safety and Inspection Sewlce Activities
                             Relating to Meat aud Poultry Safety
                             and ewrlity




                             About 7,800 federal inspectors, including many veterinarians, carry out
                             federal inspection laws in meat and poultry slaughtering and processing
                             plants and at official import inspection facilities. The in-plant inspection
                             work force consists of about 6,050 food inspectors, 180 food technolo-
                             gists, and 1,050 veterinarians.


Plant Sanitation             Before a plant can begin operating as a federally inspected establish-
                             ment, FSISmust approve its plans for facilities, equipment, and proce-
                             dures to make sure the operation will be sanitary. Facilities and
                             equipment must be easy to clean and keep clean. Each plant’s floor plan,
                             water supply, waste disposal systems, and lighting must be approved.
                             Once a plant begins operating, inspectors monitor the facilities and
                             equipment for sanitation. If, at any time, equipment is not properly
                             cleaned or an unsanitary condition is discovered, the operations are
                             stopped until the problem is corrected. During fiscal year 1989, FSIS
                             reviewed 3,851 blueprints of meat and poultry plants and 2,864 draw-
                             ings of equipment.


Inspection of Slaughtering   INS inspects all animals before they enter an establishment to be slaugh-
Plants                       tered and carcasses after slaughter. Before slaughter, FSISveterinarians
                             look for symptoms of disease and other abnormal conditions. After
                             slaughter, inspectors examine each carcass and the internal organs for
                             symptoms of disease or contamination that would make all or part of
                             them unfit for human consumption. Veterinarians supervise the inspec-
                             tors’ work to ensure uniformity in the inspection process and to provide
                             expertise in detecting diseases.


Inspection of Processing     Much of the meat and poultry slaughtered in the United States finds its
                             way into products like frozen dinners, ham, hot dogs, pot pies, sausages,
Plants                       and soups. Before a product can be marketed, FSIS reviews the
                             processing procedures and product recipes to ensure that the products
                             will be sah. Labels are checked fop WUthfuineoa @d Conformancs with
                             lalreli~g lzrwo and reguiaiions. Thg plant irktiE.f6i! ~6plifiBPStha
                             processing operations to make sure the plant adheres to the approved
                             procedures and labels.

                             Inspection in meat- and poultry-processing plants differs from inspec-
                             tion in slaughtering plants. For example, animals cannot be slaughtered
                             unless an inspector is present, while processing plants are not subject to



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                                         Food Safety and Inspection Service Activities
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                                         and Quality




                                         continuous inspection. Also, at processing plants, inspectors do not visu-
                                         ally examine all items. Instead, they monitor the plant’s operation,
                                         making use of statistical sampling and laboratory testing. Reasons for
                                         this difference are that the meat and poultry have already been
                                         inspected by FYXS at slaughtering plants and that many companies use
                                         quality control systems.


ResidueTesting                           Inspection includes checking, on a sample basis, for drug and chemical
                                         residues in slaughtered animal tissue. Residues can result from the
                                         improper use of pesticides, herbicides, animal drugs, and medicated
                                         feeds, as well as from industrial accidents that contaminate animal feeds
                                         or the environment where food animals are raised.


Laboratory Samples                       FSIS performs a large number and a variety of laboratory analyses on

Analyzed                                 meat and poultry products. Table 3.1 contains data on the type and
                                         number of laboratory samples analyzed by FSIS for fiscal years 1988 and
                                         1989 and the estimated amounts for fiscal year 1990.

Table 3.1: Laboratory Samples Analyzed
by FSIS, Fiscal Years 1988-90                                                                                          Fiscal year
                                         Sample     type
                                          I.~- ..-.-~~~...-- -.-.---   .- -.--                                1988             1989       1990 (est.)
                                         Food chemistry                                         --76@1                        62,435        -__ 62,000
                                         Food microbiology                                   --37,410               ._____    36,908           37,000
                                         C_h_emicalresidues                                                 102,714
                                                                                                                  --         185,163      .__-185,000
                                         Antibiotic residues                                                223,210     .-__ 255,851          256,000
                                                                                                                                            _I_
                                         Pathology
                                          _.- .~..                                                           11,160           11,017
                                                                                                                            .__                11,000
                                         Serology                                                             3,920             1,630__-        1,600
                                         Additives/nonfoods              --.~ -     .-----          --       12,007           10,907           10,900
                                         Radiation                                                            3,184               139 ---____         .
                                         Total                                                             463,634          564,050          563,500

                                         Source: FSIS.



Product Labels                           M S is responsible for approving formulas and labels of meat products
                                         containing over 3 percent fresh meat and poultry products containing 2
                                         percent or more cooked poultry before the products are marketed.
                                         During fiscal year 1989, BIS reviewed a total of 137,687 meat and
                                         poultry product labels. Of the total, 25,605 product labels were not
                                         approved.




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                      Food Safety and Inspection Service Activltiea
                      Relating to Meat and Poultry Safety
                      ami Q-M




Enforcement           Inspection and, where appropriate, condemnation of adulterated or mis-
                      labeled products are the most important ways in which FSISencourages
                      compliance with laws and regulations. However, the agency can take
                      other actions if they are necessary to prevent adulterated or misbranded
                      products from reaching consumers. These actions include temporarily
                      halting inspection (and thus production) until serious problems are cor-
                      rected, stopping product distribution, persuading companies to recall
                      violative products, and seeking court-ordered product seizures when
                      necessary.


Monitoring State      Under the federal-state cooperative inspection program, ISIS monitors
Inspection Programs   state inspection programs, which inspect meat and poultry products
                      that will be sold only within the state in which they are produced. The
                      purpose is to ensure that states apply inspection standards that are at
                      least equal to those of the federal program. About half the states con-
                      duct their own meat and poultry inspection programs, and about 5,700
                      plants are inspected by state programs.

                      The Federal Meat Inspection Act and the Poultry Products Inspection
                      Act require state inspection programs to be “at least equal to” the fed-
                      eral inspection program and authorize federal reimbursement of up to
                      50 percent of a state’s inspection costs. If states choose to end their state
                      inspection programs or cannot maintain the “at least equal to” standard,
                      EYEmust assume responsibility for inspection. FSIS provided about $36.5
                      million in grants to 28 states for fiscal year 1989.


Imported Products     ms is also responsible for ensuring that imported meat and poultry meet
                      the same standards as domestic products. For a country to be eligible to
                      export meat and poultry to the United States, it must impose inspection
                      requirements “at least equal to” those enforced in the United States. F’SIS
                      evaluates a country’s total inspection program to determine eligibility,
                      and ISIS officials regularly review the way the systems are operated in
                      eligible foreign countries to ensure that the requirements continue to be
                      enforced. In addition, FSIS reinspects imported meat and poultry prod-
                      ucts, on a sampling basis, when they enter the United States. As of
                      December 31, 1989, 1,431 plants in 34 countries were certified to export
                      meat or poultry to the United States.

              ”




                      FSIS activities are funded by federal appropriations, reimbursements,
Funding Levels        and trust funds. Of the $457.2 million in total funds available to FSIS in


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                                             Food Safety and Inspection 8ervke Activltien
                                             Relating tn Meat and Poultry Safety
                                             and QuaBty




                                             fiscal year 1989, about $405 million (89 percent) were federal funds,
                                             about $5 1 million (11 percent) were reimbursements (nonfederal funds),
                                             and less than 1 percent were trust funds. Table 3.2 shows FSIS’actual
                                             fiscal year 1988 and 1989 obligations and funds available and the esti-
                                             mated amounts for fiscal year 1990.

Table 3.2: Funds Available to FSIS, Fiscal
Years 1988-90                                Dollars in thousands
                                                                                                          Obligations for fiscal year
                                             -Program area                                                1988           1989      1990 (est.)
                                             Slaughter inspection                                      $250,810      $263,007        $269,070
                                             Eocessina insoection                                       119,080        122,559        125,842
                                             Import-export inspection                                    11,277         11,140         11,597
                                             Laboratory services                                         24,119         23,860         27,296
                                             Grants to states                                            35.425         36.480         36.574
                                             Total obligations                                          440,711        457,046        470,379
                                             Unobligated balance lapsing                                    156            126
                                             Total funds available                                     $440,868      $457,172        $470,379’
                                             Note: Columns may not add to totals because of rounding
                                             Source: FSIS.



                                             During fiscal year 1989, FSIS maintained a central office in Washington,
Staffing Levels                              D.C., 5 regional offices, 26 area offices, and a nationwide network of
                                             inspectors in about 7,000 establishments in the 50 states, American
                                             Samoa, Guam, Puerto Rico, and the Virgin Islands. As of September 30,
                                             1989, FSIS’staff totaled 8,942 permanent full-time employees and 810
                                             other employees. Of these, 701 permanent full-time employees (8 per-
                                             cent) and 74 other employees were located in the central offices, and
                                             460 permanent full-time employees (5 percent) and 9 other employees
                                             were in area and regional offices. The balance of 7,781 permanent full-
                                             time employees (87 percent) and 727 other employees was in field
                                             locations.

                                             Table 3.3 shows the actual staff years for fiscal years 1988 and 1989
                                             and the estimated staff years for fiscal year 1990 for FSIS’program
                                             areas. (The total staff years amounted to about 10,400 for each fiscal
                                             year.)




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                                                and Quality




Table 3.3: FSIS Staff Yearo by Program
Area, Fiscal Years 1988-90                                                                                             Staff years for fiscal year
                                                Proaram area                                                           1988            1989     1990 lest.)
                                                Slaughter inspection
                                                -~                                                                     6,969                7,004 .__       7,042
                                                Processing- inspection                                                 2,847                2,791           2,805
                                                Import-export inspection              -__                                230                  231 ____-       232
                                                -~
                                                Laboratory services
                                                              ___...-   ---.                                             384      -           373             376
                                                Grants to states                                                            .                    .               .
                                                __-.--~        ---...-
                                                Total                                                                10,430             10,399             10,455
                                                Source: FSIS

                                                Table 3.4 contains data on FSIS staffing, funding, and inspection activi-
                                                ties for fiscal years 1980 through 1989. During this period, FSIS’obliga-
                                                tions increased from $311.4 million in fiscal year 1980 to $457 million in
                                                fiscal year 1989. However, in constant 1989 dollars, FSIS actually used
                                                about 3 percent fewer funds in fiscal year 1989 than in 1980. Moreover,
                                                its staff years decreased by about 6 percent-from     11,084 in fiscal year
                                                1980 to 10,399 in fiscal year 1989. During this period of less staff and
                                                funds in constant dollars, FSIS’activities increased considerably.


Table 3.4: FSIS Resources and lnsoection Activltles. Fiscal Years 1980-89
                                                                                             Fiscal year
Resources/Activity                    1980       1981          1982      1983               1984       1985           1986        1987          1988         1989
Oblrgations (millions)               $311.4      $330.9    $351.2      5362.3 --____
                                                                                  53758              5405.1 -- $398.0     $416.4               $440.7      $457.0
Staff years                          11,084      10,705
                               ..- ~~~-. ___-...---~ _     10,511      10,490     10,486             10,672    10,239 .-~_--...~-
                                                                                                                          10,323               10,430      10,399
Establishments Inspected              7,061       7,155     7,470       7,449      7,500           -7,433       7,41 5     7,272                7,122       6,943
Pounds rnspected (mill&s)                                         ____~~.
  Slaughter
     Meat                           35,479      36,963     35,873      35,738           36,654      36,193          37,042       36,300      36,885        35,351
     Poultry                        19,444      20,305     20,575      21,179           21,546      22,980          24,273       25,700      28,213
                                                                                                                                    _-.--.-~~~~~-.-..-     29,581
                                                                                                                                                          --~
  Processrng
     Meat                           70,l IO     68,695     68,323       66,586          70,327      66,467          66,605       67,158    71,943     74,100
     Poultry                        34,614
                                ~~- -..-__      37,217     39,521
                                                               .~_..... 45,718          49,535      53,101          60,471       68,500 -~ 78,500 ___--_--.-.
                                                                                                                                                      80,850
Total                              159,647     163,180    164,292 169,223              178,062     178,741 188,391              197,658 215,541 219,882
Samples analyzed                   200,140     291,822    200,449     212,229
                                                                        - ---~.-.. 240,918         295,959         331,518      393,376       463,634     564,050
Compliance reviews ~~-
  Number                            41,715      44,283     42,403      39,909           36,661      51,957          53,i 18      42,111        56,288      60,366
  Pounds detained (millions)            14           7          7           7                6           9               23          13            11           8
Labels (thousands)
  Approved                               90        101          111         100              114            115         129           159         155          112
  Not accepted                           15         17           19          15               16             19          19            21          28           26
                                                Source: FSIS.




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                                                                               .: ;                   ‘,”
                        Part3
                        Food Safety and Inspection Sedce Actlvltiee
                        Be~~~lbleat      and Poultry f3afety




                        Table 3.4 shows that, while the amounts of slaughtered and processed
                        meat inspected remained about the same or increased slightly from
                        fiscal year 1980 to fiscal year 1989, other FSISfood safety and quality
                        inspection activities increased considerably. Examples of such increases
                        follow:

                    .   Pounds of processed poultry inspected increased about 134 percent,
                        from 34.6 billion pounds to 80.9 billion pounds.
                    .   Pounds of slaughtered poultry inspected increased about 62 percent,
                        from 19,4 billion pounds to 29.6 billion pounds.
                    .   Samples analyzed increased about 182 percent, from 200,140 to 664,050.
                    .   Labels reviewed increased about 31 percent, from about 105,000 to
                        about 138,000.
                    .   Compliance reviews increased about 45 percent, from 41,716 to 60,366.


                        To coordinate its food safety and quality activities with other federal
Coordination With       agencies, IBIS has a total of six written memorandums of understanding
Other Federal           with EPA, FDA, and/or two USDA agencies-Animal and Plant Health
Agencies                Inspection Service (APHIS) and Agricultural Research Service (ARS). Some
                        of the agreements, such as the one between EPA, FDA, and USDA to coordi-
                        nate federal regulatory activities relating to drug, pesticide, and envi-
                        ronmental contaminant residues in foods (see part l), are quite
                        extensive and involve many different matters. The following briefly
                        describes some provisions of the other five agreements and with whom
                        they were made:

                    . Inspection of Food Manufacturing Firms. This agreement with FDA,
                      which was discussed in more detail in part 1, is intended to minimize
                      duplication of inspectional effort by exchanging work-planning informa-
                      tion and referring violative conditions concerning food manufacturers
                      whose facilities are under the jurisdiction of both agencies.
                    . Recall of Meat and Poultry Products. This agreement with FDA, which
                      was also discussed in more detail in part 1, pertains to meat and poultry
                      products that have been manufactured in an Fsrs-inspectedestablish-
                      ment and that contain food ingredients that have been recalled by FDA.
                    . Surveillance for Animal Diseases in Food. This agreement with APHIS
                      involves surveillance, testing, investigation, and trace backs to points of
                      origin of diseased animals. FSS agrees to report to APHIS when carcasses
                      of slaughtered food animals are found to contain significant violative
                      residues resulting from chemicals, pesticides, or adulteration. APHIS
                      agrees to make field investigations of outbreaks of diseases that affect
                      animal health and to advise FSIS of the investigation results.


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                         Food Safety and Inspection ServiceActivities
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                         and Quality




                       . Exchange of Information Regarding Animal Samples for the Residue
                         Avoidance Program. This agreement with ARS relates to planning,
                         budgeting, and managing studies on chemical residues in meat. ARS
                         agrees to collect feed, water, medication, animal tissue, and other sam-
                         ples. FSIS agrees to conduct chemical and microbiological analysis on
                         samples at FSIS laboratories.
                       . Current Research Information System. This agreement with ARS involves
                         research on meat and poultry products done by ARS for FSIS. FSIS agrees
                         to provide ARS, by December 1 of each year, a prioritized list of its spe-
                         cific research needs. ARS agrees to carry out research directed to meeting
                         FSIS’needs within agency budgetary and resource constraints.


                         According to MS, three critical issues will face the agency during the
Critical Food Safety     1990s. The greatest will be foodborne pathogens-bacteria and viruses
and Quality Issues       capable of causing human disease. The second is chemical residues,
Facing FSIS During       including drugs, pesticides, and environmental contaminants. The third
                         is the modernization of meat and poultry inspection.
the 1990s
                         Several dozen foodborne bacteria and viruses are considered pathogens,
                         Some of these organisms have been known for a long time; however,
                         new organisms have emerged about which little is known. An example is
                         Listeria monocytogenes, which can be fatal to people with compromised
                         immune systems. While this bacterium has been found in meat and
                         poultry for several years, only recently has a confirmed case of the dis-
                         ease been traced to such a product.

                         I%IS believes that the United States needs a strong food safety research
                         program to uncover more information about emerging pathogens and to
                         find better ways to control all pathogens. It believes that, as part of this
                         research, rapid tests are needed to determine the presence of the orga-
                         nisms in food.

                         To help address the pathogen problem, FSIS has increased its sampling
                         for microbiological contaminants almost fourfold during the last 8 years.
                         In fiscal year 1989, the agency analyzed about 37,000 samples for
                         microbiological contaminants.

                         Regarding chemical residues, FSIS initiated the National Residue Program
                         more than 20 years ago to detect chemical residues in meat and poultry.
                         The program monitors meat and poultry with statistical random sam-
                         pling. Each year, FSIS conducts more than 1.5 million analyses for chem-
                         ical and drug residues, testing for 100 to 150 different compounds. The


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-
    sampling ensures a 96percent confidence of detecting a residue if it
    occurs in 1 percent or more of an animal species, nationwide. FSIS stated
    that less than 1 percent of all these tests shows illegal chemical residues,
    meaning the U.S. meat and poultry supply is in good shape regarding
    chemical contaminants. However, FSIS believes that more research,
    including development of additional rapid tests for chemical residue
    detection, is needed.

    Regarding modernization of meat and poultry inspection, FSIS believes
    that this is a necessity. To date, the United States has led the rest of the
    world in modern inspection technology and needs to continue to do so.
    The Committee on Meat Hygiene of the Codex Alimentarius Commis-
    sion-the international organization that represents countries in setting
    food standards-will be looking at modern U.S. technologies, such as the
    Streamlined Inspection System for Cattle, as well as those from other
    countries. FSIS believes that by modernizing inspection and mandating
    new technologies, it can ensure that the US. meat and poultry supply
    remains the safest in the world, as well as one of the most thoroughly
    inspected foods in the world.




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Agriculture Marketing Service Actihies     L ’
Relating to Safety and QuaUy of Egg, Dairy,
F’mit, Vegetable,Meat, and Poultry Products
                    USDA'S Agricultural Marketing Service carries out a wide array of pro-
                    grams to facilitate the marketing of agricultural products pursuant to
                    more than 30 statutes. AMS' food safety and quality activities, which are
                    at the core of the agency’s mission, are conducted pursuant to the five
                    laws discussed below.


                    The Egg Products Inspection Act, as amended (21 U.S.C. 1031 et seq.),
Major Legislation   (1) requires continual USDAinspection of all egg products- processing
                    plants, (2) requires mandatory quarterly inspections of shell egg han-
                    dlers who pack eggs for consumer sales, (3) restricts certain types of
                    shell eggs (e.g., leaking, cracked, or dirty eggs) from moving into con-
                    sumer channels, and (4) prohibits state or local governments from
                    imposing standards differing from official USDAstandards for grade and
                    size for eggs moving in interstate commerce.

                    The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et
                    seq.), authorizes the Secretary of Agriculture to provide services up6
                    request to inspect, certify, and identify the class, quality, quantity, and
                    condition of agricultural products when shipped or received in inter-
                    state commerce. The act also authorizes the Secretary to develop and
                    improve standards of quality, quantity, condition, grade, and packaging,
                    and to recommend and demonstrate such standards in order to
                    encourage uniformity and consistency in commercial practices. Domestic
                    and international standards are developed and maintained for use in the
                    grading and inspection of dairy products, fruits and vegetables, live-
                    stock, meat, poultry, rabbits, and shell eggs.

                    The Agricultural Marketing Agreement Act of 1937, as amended (7
                    USC. 601 et seq.), authorizes the establishment of marketing orders
                    and agreements to regulate the quality, quantity, or container or pack
                    requirements for fruits, vegetables, and certain specialty crops and to
                    regulate the minimum prices that handlers pay to producers of milk and
                    dairy products. The act also requires the regulation of certain of these
                    commodities imported into the United States whenever domestic ship-
                    ments of the commodities are subject to quality regulations under a mar-
                    keting order.

                    The Export Apple and Pear Act, as amended (7 U.S.C. 681 et seq.), and
                    the Export Grape and Plum Act, as amended (7 U.S.C. 691 et seq.), pro-
                    hibit the shipment of the specified fruits to any foreign destination in
                    packages that are not accompanied by a certificate of quality issued
                    under the Secretary of Agriculture’s authority.


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                                 AMS is organized along commodity lines. Five organizational units are
Organizational Units             directly involved with food safety and/or quality activities. These are
and Responsibilities             the (1) Poultry Division, (2) Livestock and Seed Division, (3) Fruit and
                                 Vegetable Division, (4) Dairy Division, and (5) Commodities Scientific
                                 Support Division.

                                 The agency’s only food safety regulatory responsibilities are in the egg
                                 products and shell egg surveillance programs. The other AMS programs
                                 discussed below are focused primarily on food quality, such as estab-
                                 lishing standards of quality and condition and grading the quality of
                                 dairy, egg, fruit, meat, poultry, and vegetable products.


                                 AMS' food safety and quality activities are conducted through the fol-
Program Activities               lowing programs:

                             l Egg Products Inspection and Shell Egg Surveillance.
                             l Commodity Standardization.
                             l Commodity Inspection and Grading.
                             9 Laboratory Testing.
                             l Governmentwide Food Quality Assurance.


Egg Prod1Acts Inspection         The Egg Products Inspection Act is intended to ensure that consumers
and Shell Egg Surveillance       receive wholesome, unadulterated, and truthfully labeled egg products
                                 and to restrict the use of certain types of shell eggs. AMS' Poultry Divi-
Programs                         sion administers the Egg Products Inspection and Shell Egg Surveillance
                                 Programs.

                                 The act requires continual USDA inspection of all egg product-processing
                                 plants involved in intrastate, interstate, and foreign commerce. In 1989,
                                 83 egg products-processing plants were subject to continual USDA inspec-
                                 tion, and all were being inspected. Poultry Division inspectors are
                                 responsible for inspecting the facilities, equipment, and methods of
                                 processing; as well as the products. The facilities and equipment are
                                 inspected for cleanliness and the ability to perform the intended func-
                                 tions. Controlling the type of egg broken is a key function of the inspec-
                                 tion system.

                                 Egg products are inspected in three forms: liquid, frozen, and dried. Fur-
                                 ther processed products, such as noodles and custards, which contain
                                 egg products but have not been considered as products of the egg food
                                 industry, are exempt and therefore not subject to inspection.


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                    The inspection methods involve visual inspection and laboratory tests.
                    Sensory examination of the product is supported by laboratory analyses
                    made by the Commodities Scientific Support Division. Food chemistry,
                    microbiology, and chemical residue tests are performed for various
                    industrial and environmental chemicals, trace elements, drug residues,
                    and similar contaminants.

                    The act also requires mandatory quarterly inspections of shell egg han-
                    dlers and restricts certain types of shell eggs from moving into consumer
                    channels to prevent their use as human food. Restricted eggs include
                    checked eggs (those with cracked shells that are not leaking) and dirty
                    eggs, which may be sent only to official USDA-inspectedprocessing plants
                    for proper handling and processing; incubator rejects (infertile or
                    unhatchable eggs); leakers (cracked eggs with contents leaking); and
                    inedible and loss (unfit for human consumption) eggs. Inedible eggs and
                    egg products must be denatured and destroyed or otherwise handled to
                    preclude their use as human food.

                    In 1989, about 1,500 shell egg-packing plants and 500 hatcheries were
                    subject to, and received, quarterly inspections by USDAor cooperating
                    state agencies. Through cooperative agreements with states, the Poultry
                    Division uses state inspection personnel to make unannounced quarterly
                    shell egg surveillance visits to shell egg-packing establishments. AMS has
                    cooperative agreements with all 50 states, Puerto Rico, and the Virgin
                    Islands. During fiscal year 1989, visits were made by nonfederal agen-
                    cies in all but five states or other jurisdictions. In these locations, federal
                    employees performed the work. AMSprovides federal oversight for the
                    state programs and reimburses states about $900,000 a year for per-
                    forming surveillance inspection work.

Import Activities   Egg products may be imported only from countries with an egg products
                    inspection system meeting the standards of the U.S. system. As of Sep-
                    tember 1989, only Canada and The Netherlands met this requirement.
                    During fiscal year 1989, about 3 million pounds of egg products in 104
                    shipments imported from these 2 countries went to 25 different U.S.
                    locations. AMS monitors the incoming products and routinely tests the
                    products for salmonella and various environmental contaminants. AMS
                    took about 210 samples for testing purposes from the 104 shipments
                    imported in fiscal year 1989.

                    All shell eggs imported during fiscal year 1989 were specifically for use
                    in producing egg products. As a result, they were processed under con-
                    tinual AMS inspection. During this time, about 659,500 30-dozen cases of


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                                         shell eggs entered the United States from Finland, East Germany, West
                                         Germany, Israel, The Netherlands, and Sweden. The eggs were
                                         processed at 5 egg-processing plants under the supervision of 11 AMS egg
                                         products inspectors. Additionally, about 21,300 30-dozen cases of
                                         hatching eggs were imported from Canada, England, Ireland, and The
                                         Netherlands.

Export Activities                        Shell eggs and egg products may be exported without special USDA certi-
                                         fication, provided that none is required by the destination country.
                                         However, when a country requires special certification, AMS personnel
                                         determine compliance and certify, under authority of the Agricultural
                                         Marketing Act, that the country’s specifications are met before the eggs
                                         or egg products are shipped.

                                         In fiscal year 1989, AMS certified about 567,000 30-dozen cases of shell
                                         eggs as meeting the requirements of Hong Kong, Mexico, Taiwan, and
                                         the United Arab Emirates. The eggs were supplied by 44 shell egg
                                         plants, each staffed by 1 or more USDA graders.

                                         In the same year, egg products shipped to only one country-West Ger-
                                         many-required special inspection. AMS certified about 112,000 pounds
                                         of egg products as meeting West Germany’s import requirements. One
                                         egg-processing plant, under continual USDA inspection, produced all of
                                         the products.

Inspection Data                          Table 4.1 contains AMS shell egg and egg products inspection data for
                                         fiscal years 1988 and 1989 and the estimated amounts for fiscal year
                                         1990. AMS estimated that the wholesale value of the products handled
                                         under this program amounted to $3.5 billion for fiscal year 1988 and
                                         $4.2 billion for fiscal year 1989.

Table 4.1: AMS Shell Egg and Egg
Products Inspection Data, Fiscal Years                                                                     Fiscal year
1988-90                                  Activity                                                 1988             1989        1990 (est.)
                                         Egg products inspected (billions of pounds)                 1.7             1.6 --____      G
                                         Egg product plants
                                                         _____I___                                   86              83 _~. ----.-. 86-
                                         Egg-handler surveillance visits                          9,723           8,769           8,200
                                         Laboratory samples analyzed
                                         _~~_..
                                             Food chemistry and microbiology
                                         --..-___                                                46,481          40,969            42,000
                                             Chemical residues                                      384             517               500
                                         Source: AMS




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Compliance and Enforcement              AMS closed about 305 cases involving health, safety, and quality issues
Activities                              relating to shell eggs and egg products during fiscal years 1988 and
                                        1989. In fiscal year 1988, 131 cases involved health and safety, and 11
                                        cases involved quality. In fiscal year 1989, AMS estimated that it closed
                                        147 health and safety cases and 16 quality cases. Table 4.2 shows the
                                        resolution of the closed cases by type of penalty.
Table 4.2: Compliance and Enforcement
Cases Closed by AMS During Fiscal       Penalty                                                                           Cases closed
Years 1988-89                                                                           ___-
                                        Letter of information                                              __~                         19i
                                        Letter of warning                                                                               66
                                        Closed without penalty                                                                          21
                                        Criminal prosecution                                                                             1
                                        Total                                                                                         305
                                        Source: AMS



Commodity                               The Commodity Standardization Program aids in the marketing of agri-
Standardization Program                 cultural commodities by providing (1) a common language of trade to
                                        ensure uniformity in grading and certifying commodities and (2) a
                                        means of measuring value to establish prices. Four AMS commodity divi-
                                        sions-Dairy, Fruit and Vegetable, Livestock and Seed, and Poultry-
                                        carry out standardization activities relating to food products.

                                        LJSDAstandards are the uniform measures of the quality and condition of
                                        agricultural commodities. Commonly recognized standards include USDA
                                        Grade AA for butter, IJSDA Grade Choice for beef, and USDA Grade U.S.
                                        No. 1 for many fruits and vegetables. Uniform standards provide identi-
                                        fication, measurement, and control of quality characteristics important
                                        to the marketing function.

                                        AMS works with industry, trade associations, academia, consumer
                                        groups, and state departments of agriculture to develop or modify
                                        grading standards. Three basic principles govern standards’ develop-
                                        ment: (1) there must be a need, (2) there must be industry interest and
                                        support because the use of USDA standards in grading is largely volun-
                                        tary, and (3) they must be practical to use.

                                        Under the Dairy Standards Program, standards are established for
                                        butter, cheese, dry milk, and related products. AMS has also promulgated
                                        General Specifications for Dairy Plants Approved for USDA Inspection
                                        and Grading Services, which establishes the requirements for USDA-



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approved dairy plants. These requirements include criteria concerning
facilities, raw materials, equipment, and operating methods. As of May
1, 1990,67 international and U.S. standards were in effect, covering 12
dairy products.

AMS has developed for state use “Recommended Requirements for Milk
for Manufacturing Purposes and Its Production and Processing.” These
recommended requirements are intended to promote, through state
adoption and enforcement, uniformity in state dairy laws and regula-
tions, as well as national uniformity in the sanitary manner in which
milk for manufacturing purposes is produced and processed. Grade A
milk, which is used mainly for drinking purposes, is under F'DA purview.

AMS has no legal responsibility for enforcing these recommended
requirements in a state. Each state is responsible for enforcement after
it has adopted the requirements. However, under the Agricultural Mar-
keting Act of 1946, AMS assists the states in an advisory and interpretive
capacity. In addition, AMS reviews the progress made toward adopting
these recommended requirements. Manufacturing-grade milk is pro-
duced in 29 states. Each year, AMS Dairy Division representatives visit
about 10 states to evaluate a random sampling of the states’ manufac-
turing-grade milk producers.

Under the Fruit and Vegetable Standards Program, standards are estab-
lished for fresh and processed fruits, vegetables, and specialty crops,
including nuts. The standards usually define such factors as color,
shape, size, maturity, and the number and degree of defects. Flavor and
texture are also rated for some products, especially those that are
processed. As of September 30,1989, 157 U.S. grade standards covering
85 fresh fruit and vegetable commodities and related foods were in
effect. Also on that date, 157 U.S. grade standards covered 74 processed
fruit, vegetable, and related products.

The Livestock and Meat Standardization Program’s primary purpose is
to provide meat graders and market reporters with the standards and
specifications to be used in the grading, certification, and market
reporting of livestock (e,g,, cattle, sheep, and swine) and meat; and to
ensure their effectiveness in providing a nationally understood language
of commerce. During fiscal year 1989,30 international and U.S. grade
standards covered 6 livestock commodities.




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                               Under the Poultry Standards Program, grade standards are developed
                               and revised for poultry, poultry products, shell eggs, and rabbits. Com-
                               modity purchase and federal specifications are also developed. During
                               fiscal year 1989, 10 U.S. grade standards were in effect, covering 4
                               commodities,


Commodity Inspection and       The Commodity Inspection and Grading Program is intended to facilitate
Grading Program                the interstate and foreign commerce of agricultural products. This is
                               accomplished by inspecting, identifying, and certifying the quality of
                               these products in accordance with official standards. Grades serve as
                               the basis for prices and reflect the product’s value to the farmer and the
                               buyer. Each of AMS' four food commodity divisions carries out com-
                               modity inspection and grading activities.

                               Inspection and grading services are generally voluntary, rather than
                               mandatory or regulatory, and recipients pay for the requested service.
                               AMS inspection and grading activities are carried out by (1) inspectors,
                               graders, and classers assigned to regional offices, field offices, and labo-
                               ratories, which are geographically located according to the industry
                               being served, or (2) licensed state/commonwealth employees under
                               agreements with those governments.

Dairy Inspection and Grading   AMS carries out dairy inspection and grading activities through three
                               programs-plant     surveys, inspection and grading, and resident grading
                               and quality control-which     are directed at evaluating the wholesome
                               production, quality, manufacture, and distribution of dairy products.
                               About 700 establishments are eligible for dairy inspection and grading
                               services.

                               Each plant survey is made by a dairy inspector, who makes detailed
                               checks on more than 100 items. A plant survey informs the plant man-
                               ager about the factors affecting the quality and wholesomeness of the
                               finished product-quality   of raw material, sanitation, condition of plant
                               and equipment, and processing procedures. Associated with the plant
                               surveys is the equipment review process, which evaluates the sanitary
                               design of processing equipment prior to its installation in the processing
                               facility.

                               Grading encourages manufacturers to produce uniformly high-quality,
                               stable products that will bring top prices. The manufacturer, in turn,
                               encourages the producer to produce top-quality milk and cream.



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                                      Resident grading and quality control service, available to approved
                                      plants, is a combination of the plant survey, inspection and grading, and
                                      laboratory programs. An inspector stationed at the plant on a full-time
                                      basis performs quality checks on plant and equipment sanitation and
                                      grades and certifies the finished product.

                                      Inspection and grading data. Table 4.3 shows dairy inspection and
                                      grading program data for fiscal years 1988 and 1989 and the estimated
                                      amounts for fiscal year 1990. AMS' Dairy Division does not maintain
                                      records of the dollar value of the dairy products produced by the
                                      inspected establishments.

Table 4.3: AMS Dairy Inspection and
Grading Data, Fiscal Years 1988-90                                                                    Fiscal year
                                                                                              1988            1989         1990 (est.)
                                      Davy products (millions of pounds)                      3,026           1,917              1,905
                                      Number of olant insoections                             1.987           1.800              1.750
                                      Source: AMS.

                                      Export and import activities. AMS inspection services are available to
                                      establishments that export dairy products. AMS does not maintain
                                      records of the number of requests, locations, or samples destined for
                                      export. AMS has no involvement with dairy product imports, which are
                                      under FDA jurisdiction.

Fruit and Vegetable Inspection        For fresh products, AMS offers commercial shippers shipping point
and Grading                           inspection for quality and condition of fresh fruits, vegetables, nuts, and
                                      other miscellaneous products. This inspection establishes the commodi-
                                      ties’ quality at the time of shipment for sales purposes or verifies com-
                                      pliance with contract terms.

                                      Receivers in terminal markets can have AMSinspect shipments for both
                                      quality and condition or for condition only. Many receivers use this
                                      inspection to determine whether or not an arriving shipment meets con-
                                      tract terms, to help them decide the best use for a particular shipment,
                                      or to aid them in selling their produce.

                                      For processed products, AMS performs inspection and/or grading ser-
                                      vices on either an in-plant or lot inspection basis, depending on the
                                      applicant’s wishes and the special requirements of the particular con-
                                      tract or program. In-plant inspection is done during the manufacturing
                                      process and involves observing the condition and acceptability of raw
                                      material, monitoring plant sanitation, performing on-line checks of the


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product at various stages of processing, and final grading of the finished
product. Lot inspection involves drawing samples from specifically iden-
tified lots and determining the grade of the lots on the basis of examina-
tion and testing of the samples.

For both in-plant and lot inspection, microscopic and other special tests
and analyses are often required before AMS certifies the product’s
quality and condition.

Fruit and vegetable establishments are not subject to mandatory inspec-
tion, although a firm may contract for continuous in-plant AMS inspec-
tion if it wishes to do so. Most fruit and vegetable quality inspections
are done on a voluntary basis wherever the product is located. The
inspection location is specified by the party requesting the service; for
fresh products, it can be the shipper’s loading dock, receiver’s store,
port facility, etc. Generally, fresh inspections occur in the vicinity of 1
of the approximately 130 federal-state shipping point inspection offices,
32 federal receiving markets, or the 100 federal-state collaborator
receiving markets.

Processed fruit and vegetable inspections may be done at the processing
plant, or samples may be taken to an inspection office for analysis. For
processed products, AMS has 21 area field offices and 16 suboffices and
inspection points. During fiscal year 1989, AMS had inspection contracts
with 323 processors and 3,346 active accounts for processed
inspections.

Relationship to state inspection programs. For fresh products, AMS has
cooperative agreements in all 50 states and Puerto Rico. Under these
agreements, AMS supervises and trains state inspectors in methods of
interpreting and applying U.S. grades, performing inspections, and pre-
paring official U.S. certificates. AMS licenses those employees it considers
qualified to serve as inspectors. The total number of state employees
licensed on an annual basis is in excess of 5,500, representing about
2,500 staff years. AMS may also appoint licensed state inspectors to
serve as collaborators so that they may inspect products that originate
in states other than the one where the inspection is conducted. AMS has
appointed about 360 such employees as collaborators.

For processed products, federal employees perform the bulk of inspec-
tion activities. However, AMS has formal agreements with the Hawaii
and Virginia state inspection programs and Puerto Rico. Under these



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agreements, AMS provides federal supervision of state employees and is
reimbursed for supervisory expenses by the states or Puerto Rico.

Import activities. Section 8e of the Agricultural Marketing Agreement
Act requires that certain imported fruits and vegetables meet the same
quality requirements as domestic products during the effective periods
of domestic marketing order regulations. These commodities, which are
to be inspected for quality before clearing customs, are avocados, dates
(other than for processing), filberts, grapefruit, table grapes, limes,
olives (other than Spanish-style olives), onions, oranges, Irish potatoes,
prunes, raisins, tomatoes, and walnuts. As of October 1990, legislation to
add apples, kiwifruit, plums, nectarines, papayas, and pistachios was
pending.

The importer is responsible for contacting AMS to request inspection of
these imported products. The United States Customs Service is required
to hold the products until AMS certifies that they meet section 8e import
requirements.

Whether mandatory under section 8e or voluntary upon request, AMS
inspections may occur at any port of entry. For fresh fruits and vegeta-
bles, the greatest volumes of imports are inspected at six locations-Los
Angeles and Otay Mesa, California; Nogales, Arizona; Reynosa and
McAllen, Texas; and Philadelphia, Pennsylvania. Data on the number of
import inspectors and amount of imported products inspected are not
available because inspectors are not assigned specifically to imports and
only aggregate figures of imported and domestic products are
maintained.

Agriculture Canada (USDA'S counterpart in Canada) is an authorized
inspection agent for certifying onions, potatoes, and tomatoes destined
for import into the United States. Therefore, AMS does not usually
inspect these commodities for compliance with section 8e requirements.
However, under the Food Security Act of 1985 (P.L. 99-198), U.S. fed-
eral-state inspectors conduct spot-check inspections of imported Cana-
dian potatoes at border points in Maine on a restricted basis. In the
1988-89 season, 414 inspections were made for section 8e requirements
and labeling requirements under the Perishable Agricultural Commodi-
ties Act.

Export activities. AMS certifies, under the Export Apple and Pear Act
and the Export Grape and Plum Act, that exported apples, grapes, and
pears meet certain minimum quality standards. (Plums are not currently


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                                      regulated.) In addition, AMS and designated state inspectors are author-
                                      ized by Agriculture Canada to certify the quality of 27 fresh fruit and
                                      vegetable commodities which are required to meet minimum quality
                                      requirements before being allowed into Canada. AMSdoes not maintain
                                      data on inspection of export shipments or the number of inspectors
                                      involved in certifying the quality of fruit and vegetable exports.

                                      Inspection and grading data. Table 4.4 shows fruit and vegetable inspec-
                                      tion and grading data for fiscal years 1988 and 1989 and the estimated
                                      amounts for fiscal year 1990. AMS' Fruit and Vegetable Division does not
                                      have an official estimate of the value of the fruits and vegetables
                                      inspected and graded.
Table 4.4: AMS Fruit and Vegetable
lnrpection and Grading Data, Fiscal                                                                     Fiscal year
Years 1988-90                         Activity                                                  1988            1989          1990 (est.)
                                      Inspection/grading
                                         Fresh fruits and vegetables (billions of
                                            pounds)                                              74.6             74.6               75.0
                                         Processed fruits and vegetables (billions of
                                            ooundsl                                               8.7              8.7                8.8
                                      Laboratory analyses of processed products
                                         (thousands)                                             173              210                195
                                      Source: AMS.


Meat Grading and Certification        For meat, AMS provides quality- and yield-grading services and certifica-
                                      tion services. Quality grades, such as USDA Prime and USDA Choice, iden-
                                      tify the palatability (tenderness, juiciness, and flavor) of meat. Yield
                                      grading indicates the amount of usable meat a carcass will yield after
                                      the waste fat and bone have been trimmed off.

                                      The meat certification service provides large-volume purchasers with
                                      consistent and uniform meat and meat products, regardless of the meat
                                      supplier. Products, such as ground beef, steaks, roasts, frankfurters, and
                                      other meat items are examined by meat graders to ensure that the prod-
                                      ucts conform to the purchasers’ contract requirements.

                                      AMS may perform voluntary grading and certification services in any of
                                      the approximately 6,700 establishments operating under Food Safety
                                      and Inspection Service regulations. The frequency of services for the
                                      establishments that receive voluntary grading and certification services
                                      from AMS ranges from daily to very infrequently.




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                                               Relationship to state grading and certification programs. AMS has coop-
                                               erative agreements with 11 states regarding voluntary meat grading and
                                               certification services. For two states (Hawaii and Virginia) the agree-
                                               ments provide for the states to use federal meat graders to perform the
                                               requested services. For nine states (Georgia, Indiana, Louisiana, Maine,
                                               Montana, New York, North Carolina, Utah, and Vermont), state
                                               employees trained and supervised by AMS perform the requested
                                               services.

                                               Import and export activities. For meat and meat products, imports and
                                               exports are regulated by FWS,pursuant to the Federal Meat Inspection
                                               Act.

                                               Grading and certification data. Table 4.5 shows meat grading and certi-
                                               fication data for fiscal years 1988 and 1989 and the estimated amounts
                                               for fiscal year 1990. AMS estimated that the value of meat products han-
                                               dled in fiscal year 1988 amounted to $37 billion.

Table 4.5: AMS Meat Grading and
Certification Data, Fiscal Years 1988-90                                                                        Fiscal year
                                               Activity/commodity
                                               --                                                        1988           1989        1990 (est.)
                                               Graded
                                               --~      (millions of pounds)
                                                  Beef                                                12.478          14,294            14,671
                                                  Lamb                                                    283            289               290
                                                  Veal and calf                                            39             39                39
                                               Total                                                 12.800          14.622             15.000
                                               Certified (millions of pounds)
                                                 Meat and meat oroducts                                   700            759               800
                                               Source: AMS

Poultry Grading                                AMS' principal poultry-grading           activities are

                                           . grading, identification, and certification of poultry, poultry products,
                                             shell eggs, and domestic rabbits as to class, quality, quantity, and
                                             condition;
                                           l acceptance services;
                                           . approval of shell egg-grading facilities; and
                                           . approval of shell egg and poultry labels bearing the USDA grade mark.

                                               Grading services are voluntary, and plants are subject to program
                                               requirements only if services are requested. About 190 poultry plants
                                               and 180 shell egg plants receive grading services on a full-time basis.



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                                       About 30 poultry plants and 25 shell egg plants receive grading services
                                       on a part-time basis. An undetermined number of firms request and
                                       receive lot-grading services.

                                       AMS has cooperative agreements on poultry grading with all 50 states,
                                       Puerto Rico, and the Virgin Islands.

                                       Export activities. AMS export activities concerning shell eggs, egg prod-
                                       ucts, and poultry vary widely from year to year, depending on such fac-
                                       tors as foreign country needs, domestic and foreign market conditions,
                                       and incentive programs, such as the Export Enhancement Program.

                                       For foreign countries requiring special certification of shell eggs and
                                       poultry, Poultry Division grading personnel determine compliance and
                                       certify that the countries’ specifications are met before the products are
                                       shipped.

                                       In fiscal year 1988, 151,000 metric tons of whole chickens and leg
                                       quarters were certified for shipment to various foreign countries under
                                       USDA'S Export Enhancement Program. In fiscal year 1989,1,800 metric
                                       tons of product were certified by AMS for shipment to foreign countries
                                       under this program.

                                       Grading data. Table 4.6 shows poultry-grading data for fiscal years
                                       1988 and 1989 and the estimated amounts for fiscal year 1990. AMS esti-
                                       mated that the wholesale value of the products handled in fiscal years
                                       1988 and 1989 amounted to $11.2 billion and $12,8 billion, respectively.

Table 4.6: AMS Poultry-Grading Data,
Fiscal Years 1988-90                                                                                        Fiscal year
                                       Activity                                                     1988            1989   1990 (est.)
                                       Poultry products and rabbits graded (millions
                                         of pounds)                                                14,715         14,401       15,400
                                       Shell eggs graded (millions of dozens)                       1,689          1,557        1,518
                                       Vabbits graded amounted to less than 1.5 million pounds per year.
                                       Source: AMS.


Compliance and Enforcement             Because AMS' Commodity Inspection and Grading Program services are
Activities                             generally voluntary in nature, compliance and enforcement become
                                       issues only when a service recipient tries to gain an unfair advantage
                                       through misuse of an AMS service. This could include such things as
                Y                      alteration of an official grading certificate, misrepresentation of product
                                       quality, or economic adulteration. In the last 3 fiscal years (1987-89),


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                      AMS took a total of 80 enforcement actions with dispositions ranging
                      from letters of warning to fines and imprisonment.


Laboratory Testing    Through its Laboratory Testing Program, AMS' Commodities Scientific
Program               Support Division conducts a wide range of laboratory tests on agricul-
                      tural commodities to aid the commodity divisions in their inspection and
                      grading activities. It also ensures that commercial and private laborato-
                      ries used by AMS are performing tests in a consistent, uniform, and accu-
                      rate manner; and it develops and tests new and improved laboratory
                      methodologies and coordinates a laboratory safety program.

                      The Laboratory Testing Program has 2 multidisciplinary laboratories, 1
                      citrus-testing laboratory, and 10 aflatoxin laboratories. The laboratories
                      analyze a variety of commodities, including raw meat and poultry,
                      frozen and dried egg products, orange juice concentrate, peanut prod-
                      ucts, dairy products, fruits and vegetables, and prepackaged military
                      meals, for compliance with federal and state specifications. Tests are
                      done to detect natural constituents and microbiological, chemical, envi-
                      ronmental, and pharmaceutical contaminants, as well as to determine
                      quality and product acceptance. Quality assurance and reliability of
                      results are maintained through on-going monitoring of AMS laboratories
                      and private and commercial laboratories used by AMS.


Governmentwide Food   The Governmentwide Food Quality Assurance Program is intended to
Quality Assurance     develop, coordinate, and approve food product descriptions; establish
                      uniform quality assurance policies and procedures for food procured by
Prqgram               federal agencies; and ensure that the federal government buys its food
                      as efficiently and economically as possible. Under this program, AMS
                      program specialists

                      establish and maintain quality assurance and specification policies and
                      procedures for food procured by the federal government;
                      establish and maintain an interagency program for coordination of spec-
                      ifications between users, regulatory agencies, inspection and acceptance
                      agencies, and industry;
                      ensure compliance with laws and regulations in the development of food
                      specifications;
                      review and approve all food specifications developed by USDA and other
                      federal agencies; and
                      maintain an inventory of food purchase specification documents used by
                      federal agencies.


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                                          The program has approved federal governmentwide specifications for
                                          such products as frozen ground beef products, ready-to-cook chilled and
                                          frozen chicken, and dehydrated white potatoes. A single document is
                                          now used by all federal agencies to procure these products. Since fiscal
                                          year 198 1, 125 Commercial Item Descriptions for food products have
                                          been developed and approved.


Inspection/Grading                        Table 4.7 shows selected AMS inspection and grading workload data for
Workload Data, Fiscal                     fiscal years 1980, 1985, and 1989 to illustrate the changes in workload
                                          during the 1980s.
Years 1980,1985, and
1989
Table 4.7: Selected AMS Inspection/
Qrading Workload Data, Fiscal Years                                                                        Fiscal year
1980,1985, and 1989                       Product inspected/waded                                 1980             1985               1989
                                          Egg  products (billions of pounds)
                                          ..___--                                                    1.1            1.3                1.6
                                          Shell eggs (billions of dozens)                            2.1            1.8        I__-    1.6
                                          Dairy products
                                          --_____    --     (billions of pounds)                     3.4            4.4                1.9
                                          Fresh fruits and vegetables (billions of
                                             pounds) __                                            72.9            71.6               74.6
                                          Meat products (billions of pounds)                       12.3            13.1               14.6
                                          Poultry products and rabbits (billions of
                                             pounds)                                                12.1           12.7               14.4
                                          Source, AMS


                                      -
                                          AMS' food safety and quality activities are funded through a combination
Funding Levels                            of appropriated funds and user fees. Federal appropriations fund the
                                          Governmentwide Food Quality Assurance Program, standardization
                                          activities, and the mandatory provisions of the Egg Products Inspection
                                          Act. User fees fund AMS' voluntary commodity inspection and grading
                                          activities.

                                          Table 4.8 shows AMS' actual obligations for its food safety and quality
                                          activities for fiscal years 1988 and 1989 and the estimated amounts for
                                          fiscal year 1990.




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Table 4.8: AMS Obligations for Food
Safety and Quality Activities, Fiscal   Dollars in thousands
Years 1988-90                           --
                                                                                                              dblieations
                                        Program
                                        -.~____           ---
                                                                                                      1988             1989       1990 (est.)
                                        Shell Egg Surveillance and Egg Products
                                           Inspection                                               $9,711           $9,918         $10,239
                                                                                                                                 ____-
                                        Standardization
                                         .-_________---                                              2,330            2,270 __--..-    2,461
                                        Commodity -II_lnspectfon and Grading
                                                              ____-~                                81,700           81,815           82,272
                                                                                                                                     ~----
                                        Laboratory
                                        I__-         Testinga                                           -             2,178            3,639
                                        Governmentwide Food Quality Assurance                          772              777      -__      777
                                        Total                                                     $94,513          $98,958           $99,388
                                        % fiscal year 1988 and part of 1989, Laboratory Testing Program obligations were charged to the other
                                        AMS food safety and quality programs.
                                        Source: AMS.



                                        AMS, headquartered in Washington, D.C., had about 310 year-round and
Staffing Levels                         seasonal field offices during fiscal year 1989. As of September 30, 1989,
                                        AMS had 3,470 full-time employees and 1,357 other employees, of which
                                        2,825 of the former and 1,334 of the latter were assigned to field office
                                        locations.

                                        AMS has a permanent, full-time staff of about 2,400 working on food
                                        safety and quality activities. In addition, AMS employs hundreds of sea-
                                        sonal or intermittent workers and obtains the services of thousands of
                                        others through cooperative agreements, mostly with state departments
                                        of agriculture.

                                        Table 4.9 shows the actual staff years AMS expended on food safety and
                                        quality activities during fiscal years 1988 and 1989 and the estimated
                                        amounts for fiscal year 1990.




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Table 4.9: AMS Staff Years for Food
Safety and Quality Activities, Fiscal                                                                            Fiscal year
Years 1988-90                           Program                                                        1988              1989      1990 (est.)
                                        Shell Egg Surveillance and Egg Products
                                          Inspection
                                          Federal                                                        203      --      201               199
                                          State                                                           47               45                44
                                        Standardization                                                   41               39
                                                                           -~                                                               - 42
                                        Commodity Inspection and Grading
                                            Federal                                                    2,090            2,070            2,005
                                        ----        ____.-.
                                           State                                                         313              324
                                        -~-~                                                                                        ___-- 322
                                        Laboratorv Testin@                                                   .             50               81
                                        Governmentwide Food Quality Assurance                              12               12               12
                                        ._--- -..-          --
                                        Total                                                          2.706            2.741            2.705
                                        *In fiscal year 1988 and part of 1989, Laboratory Testing Program staffing was included in the other AMS
                                        food safety and quality programs.
                                        Source: AM.5



                                        AMS coordinates with five USDA agencies and nine other federal agencies
Coordination With                       to avoid duplication of effort, conflicting actions, or overlapping juris-
Other Federal                           diction in carrying out its food safety and quality activities.
Agencies                                Within USDA, AMS coordinates with the Agricultural Research Service,
                                        Animal and Plant Health Inspection Service, Cooperative State Research
                                        Service (CSKS), Federal Grain Inspection Service, and the Food Safety
                                        and Inspection Service.

                                        In the Governmentwide Food Quality Assurance Program, AMS coordi-
                                        nates with the Bureau of Prisons, the Department of Defense, the
                                        Department of Veterans Affairs, the Indian Health Service, and the
                                        National Institutes of Health.

                                        The remainder of this section discusses AMS coordination with other fed-
                                        eral agencies for fruit and vegetable products; poultry, shell eggs, and
                                        egg products; dairy products; meat products; and the salmonella inter-
                                        agency task force.


Fruit and Vegetable                     AMS coordinates its quality inspection activities for imported fresh and
                                        processed fruits, vegetables, and related products with the United States
Products    y                           Customs Service and FDA and its inspections of processed foods with FDA,
                                        the Department of Defense, the National Marine Fisheries Service, and



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                           FGIS.AMS is also party to the memorandum of understanding with FSIS,
                           FDA, and EPA on regulatory activities concerning residues of drugs, pesti-
                           cides, and environmental contaminants in foods. (See part 1.)


Poultry, Shell Eggs, and   USDA has exclusive jurisdiction for inspecting egg products in official egg
Egg Products               products plants operating under mandatory egg products inspection.
                           However, a limited number of egg products plants also process foods
                           that are regulated by the requirements of the Federal Food, Drug, and
                           Cosmetic Act; Federal Meat Inspection Act; or Poultry Products Inspec-
                           tion Act (PPIA). Accordingly, these plants’ operations are subject to
                           inspection by FDA and ITSIS,as well as AMS.

                           Shell egg-packing plants are subject to inspection by AMS and FDA. Under
                           the Shell Egg Surveillance Program, USDA inspects shell egg-packing
                           plants at least four times each calendar year to determine compliance
                           with Egg Products Inspection Act requirements. These plants are also
                           regulated by FFDCA provisions and, therefore, are subject to FDA inspec-
                           tion. In plants where AMS voluntary poultry-grading services are pro-
                           vided, PPIA regulations for poultry plants apply.


Dairy Products             AMS, FDA, and state agencies make similar inspections of dairy plants.
                           USDA inspections concentrate on issues such as sanitation; facilities; and
                           product safety, stability, and quality, which are important factors in a
                           product-grading system. FDA and state inspections focus mainly on
                           checking and enforcing minimum standards of operation regarding
                           product safety, sanitation, facilities, licensing, and weight control.

                           Under a memorandum of understanding with FDA, AMS has carried out a
                           salmonella surveillance program at dry milk product plants for over 25
                           years. (See part 1.) The program involves quarterly testing of product
                           and environmental samples, together with a detailed system of follow-
                           up in the event of positive results. AMS keeps FDA informed about the
                           overall testing program and about testing in progress at plants that are
                           experiencing salmonella control problems. The incidence of positive
                           results in routine testing is less than one-fourth of 1 percent.


Meat Products              AMS provides voluntary meat quality services (grading) to the livestock
           ”               and meat industry. These services are generally rendered at meat-
                           packing plants. Within these same plants, FSIS provides mandatory regu-
                           lation of the meat industry. AMS has developed a close relationship with


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                             ISIS to accomplish the missions of both programs. One example is an
                             interagency memorandum of understanding that authorizes AMS per-
                             sonnel to retain products, in the absence of an FSIS inspector, that may
                             be in violation of meat inspection regulations.

                             Similarly, FSIS has legislative responsibility to control the labeling of
                             meat products, including grade labeling. FSIS assists in maintaining the
                             integrity of the AMS meat quality grades by approving only labels that
                             honestly represent the product’s grade.


Salmonella Interagency       AMS served as the coordinator of a USDA/FDA interagency task force
                             established to reduce the possibility of outbreaks of salmonella enteri-
Task Force                   tidis in humans and domestic poultry flocks. USDA agencies cooperating
                             with AMS include APHIS,ARS,CSRS, and FSIS.

                             Task force efforts have resulted in a comprehensive plan, which
                             includes a voluntary flock-testing program, a public awareness cam-
                             paign, and cooperative research efforts.

                             In February 1990, USDA implemented a mandatory flock-testing program
                             conducted by APHIS. As a result, APHIS now serves as the USDA coordi-
                             nator of the USDA/FDA interagency task force.


                             According to AMS, some of the most critical food safety and quality
Critical Food Safety         issues it may be involved in during the 1990s include
and Quality Issues
Facing AMS During        .
                         l
                             microbiological contamination,
                             residue contamination,
the 1990s                .   biotechnology,
                             voluntary pesticide residue testing,
                             mandatory quality inspection for imported fruits and vegetables,
                             international harmonization of food regulations,
                             nutritional content of food, and
                             other issues (e.g., growth-promoting hormones in food animals and food
                             irradiation).


Microbiological              Although chemicals and food safety have been in the spotlight recently,
                             AMS believes that microbiological contamination contributes to more sig-
Contaminatibn                nificant health problems. Although great progress has been made in



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                        identifying and preventing some foodborne diseases, outbreaks of micro-
                        bial origin continue to persist or are on the rise. Also, previously unrec-
                        ognized pathogenic microorganisms are being acknowledged, and new
                        techniques in food processing and preservation portend new types of
                        safety and wholesomeness issues.

                        USDA, in conjunction with FDA and outside experts, has established a
                        National Advisory Committee on the Evaluation of Microbial Criteria for
                        Food. The Committee is tasked to recommend microbiological standards
                        applicable to foods under each federal agency’s jurisdiction. The stan-
                        dards will be used in the agencies’regulatory processes or quality
                        assessments. Also, the Committee will address the use of a Hazard Anal-
                        ysis and Critical Control Point system for specific commodities. The
                        system consists of identifying, assessing, monitoring, and controlling
                        hazards associated with growing, harvesting, processing, marketing,
                        preparing, and using a given raw material or food product.


Residue Contamination   AMS said that chemical contamination also is high on its agenda for the
                        future. Its strategy for residue control is to help industry prevent the
                        incidence of residues and to use more rapid tests to detect residues when
                        they are present. AMS believes that prevention is the most efficient and
                        cost effective course of action. It also believes that a need exists for a
                        centralized pesticide residue information data base that can be used to
                        communicate objective, comprehensive information on those residues to
                        the public.


Biotechnology           AMS stated that the potential impact of biotechnologies on agricultural
                        productivity and product quality is entering a revolutionary period. Key
                        advances are being made in the areas of (1) genetically engineered
                        pharmaceuticals designed to promote animal growth, cause selective
                        partitioning of nutrients, and improve animal product quality; (2) vac-
                        cines against animal diseases; (3) mass production (in vitro) of identical
                        embryos by using transgenic material to enhance animal product
                        quality, quantity, or production efficiency; (4) genetically engineered
                        crops that fix their own nitrogen; and (5) the development of biological
                        pesticides for or actually part of plants. AMS believes that these innova-
                        tions will enable the agricultural community to achieve greater or safer
                        production, better utilize products, and address worldwide food inade-
                        quacy problems.




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Voluntary Pesticide       According to AMS, the U.S. produce industry is debating whether fresh
Residue Testing           fruits and vegetables should be tested for pesticide residues on a volun-
                          tary basis. Some parties fear that such a practice would be used as a
                          marketing tool, implying that untested produce is unsafe. There also is
                          concern that some third-party testing companies do not offer their ser-
                          vices to all interested customers in a geographic area.


Mandatory Quality         Legislation has been proposed to expand the list of commodities under
Inspection for Imported   Section 8e of the Agricultural Marketing Agreement Act, whose imports
                          must meet minimum quality standards during the effective period of
Fruits and Vegetables     domestic marketing orders. AMS believes that the trend toward manda-
                          tory quality inspections for imports may expand in the future.


International Agreement   AMS said that many efforts are ongoing involving international agree-
                          ment-technically called harmonization-of technical regulations
                          relating to food, such as those addressing pesticides residues, phytosani-
                          tary requirements, packaging, and labeling. Other organizations
                          involved with efforts to harmonize technical requirements for food
                          include the Codex Alimentarius Commission, the Organization for Eco-
                          nomic Cooperation and Development, and the Economic Commission for
                          Europe.


Nutritional Content of    With the growing emphasis on health and nutrition, demand is
                          increasing for improved nutritional labeling and reducing the amounts
Food                      of sodium, fat, and cholesterol in food. In addition, food companies are
                          continuing to use health messages in advertising and on labels.


Other Issues              Examples of other food safety and quality issues that AMS is or could
                          become involved in include the use of growth-promoting hormones in
                          food animals, mandatory fish inspection, groundwater contamination,
                          pesticides under special review by EPA, microwave cooking, fat substi-
                          tutes, food irradiation, aflatoxin and other molds, rapid-testing method-
                          ology and approvals, foodborne microorganisms and their toxins,
                          detection and quantification of foodborne viruses, mycotoxin contami-
                          nation of food commodities, and veterinary drug residues in egg
                          products.




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Federal Grain hspection Service Activities
Relating to Safety and Quality of Grain, Rice,
and Related Commodities
                        USDA'S Federal Grain Inspection Service’s primary mission is to facilitate
                        the marketing of grain, oilseeds, pulses (e.g., peas), rice, and related
                        commodities by, among other things, (1) establishing descriptive stan-
                        dards and terms, (2) accurately and consistently certifying quality, and
                        (3) providing for uniform official inspection and weighing.

                        NW food safety and quality activities include (1) helping ensure food
                        safety by inspecting corn, sorghum, and rice for aflatoxin; (2) devel-
                        oping and disseminating information about chemical residues in grain
                        which is used by other agencies to establish permissible levels of pesti-
                        cides in grain at the marketplace; and (3) helping ensure food quality by
                        inspecting the quality of domestic and exported grain.


                        FGIS is responsible for administering the U.S. Grain Standards Act
Major Legislation       (IJSGSA), as amended (7 USC. 71 et seq.), and providing inspection and
                        weighing services for rice and grain-related products under the Agricul-
                        tural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.).

                        To help advance the orderly and efficient marketing and effective distri-
                        bution of grain and related products to domestic and foreign buyers, FGIS
                        develops and enforces standards that measure and describe the com-
                        modities’ physical and biological properties and promotes their use as a
                        language of commerce. The standards provide buyers and sellers, who
                        may never see each other, an understanding and assurance of what is
                        being traded. FGIS is responsible for ensuring that these standards are
                        applied fairly and accurately and thereby promotes and protects such
                        commerce. Under USGSA, FGIS has established standards for 11 grains-
                        barley, corn, flaxseed, mixed grain, oats, rye, sorghum, soybeans, sun-
                        flower seed, triticale, and wheat.

                        USGSA

                    9 requires a national inspection and weighing system for grain;
                    . requires that, with few exceptions, export grain be inspected and
                      weighed;
                    . provides for inspection and weighing services for domestic grain on
                      request;
                    9 prohibits deceptive practices and criminal acts with respect to the
                      inspection and weighing of grain; and
                    l provides penalties for violations.




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                            Federal Grain Inspection Service Activities
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                            and Related Commodities




                            USGSAwas amended in 1981 to require FGIS to collect user fees from offi-
                            cial agencies (states and private agencies which perform inspection and
                            weighing services) to fund the costs associated with supervising the fed-
                            eral grain inspection and weighing activities of official agencies.

                            The Agricultural Marketing Act of 1946 requires FGIS to provide, on
                            request and for a fee, official inspection and weighing services for
                            domestic and export shipments of rice and grain-related products. The
                            commodities covered by the act include dry beans, dry peas, hops, len-
                            tils, processed grain products, pulses, rice, and related commodities.


                            During fiscal year 1989, FGIS carried out its inspection and weighing ser-
Organizational Units        vices through headquarters staffs in Kansas City, Missouri, and Wash-
and Responsibilities        ington, D.C., and a field staff comprising 27 field offices, 2 federal/state
                            offices, and 8 suboffices.

                            FGIS also used 20 states and 57 private agencies designated to provide
                            official services at interior points. Of these, eight states are also dele-
                            gated to perform official inspection and weighing services at export
                            points.

                            The FGIS organizational units involved directly with food safety and
                            quality activities are the (1) Quality Assurance and Research Division,
                            (2) Field Management Division, (3) International Monitoring Staff, and
                            (4) Compliance Division. Their responsibilities are discussed below.


Quality Assurance and       The Quality Assurance and Research Division is responsible for
ResearchDivision        l   developing new objective tests and methods for determining grain
                            quality,
                        .   providing reference standards for FGIS methods and developing new ref-
                            erence standards as required,
                        .   developing criteria and recommending specifications for electronic
                            instrumentation to improve the reliability of grain inspection,
                        9   developing and maintaining an agencywide quality control program cov-
                            ering all aspects of grading and inspection,
                        .   developing and carrying out an equipment approval program,
                        .   developing and maintaining an agencywide quality assurance sample
                            program,
                        .   maintaining uniform application of standards for grains and
                            commodities,


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                            l   rendering final decisions on inspection appeals, and
                            l   conducting technical training for field personnel.

                                According to FGIS, the Division will play a major role during the next 5
                                years in moving FGIS toward more objective testing to replace subjective
                                tests for grain quality. To help ensure such a move, the Division will
                                continue to improve the monitoring of existing test methods, update ref-
                                erence methods as scientific procedures change, develop specifications
                                for electronic instrumentation, initiate and carry out an instrument-type
                                evaluation and approval program, and implement a quality control pro-
                                gram covering all aspects of grain grading and equipment check testing.
                                Further, major emphasis will be placed on technical training of field
                                personnel.


Field Management Division       The Field Management Division is responsible for

                            l directing the operations of FGIS field offices;
                            l developing inspection and weighing policies and procedures;
                            . establishing the U.S. standards for grain, pulses, rice, and other
                              commodities;
                            . overseeing delegated and designated agencies; and
                            l monitoring the quality of grain as it moves through the market.

                                FGIS said that, during the next 5 years, the Division must concentrate on
                                advancing new testing and automated data processing technology into
                                the daily operations of the national inspection service.


International Monitoring        The International Monitoring Staff administers the monitoring program
                                for U.S. grain shipments exported to foreign nations to evaluate
Staff                           whether the quality and weight of grain received by foreign importers is
                                comparable (within expected variation) to the quality and weight certi-
                                fied upon official inspection in the United States. In doing so, it investi-
                                gates foreign complaints on grain quality, meets with foreign purchasers
                                of U.S. grain to gather information about the quality of U.S. grain they
                                import, conducts educational briefings for importers, and coordinates
                                FGIS activities involving foreign travel One overall objective is to contin-
                                ually enhance the credibility and image of FGIS in the international grain
                                marketplace.




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Compliance Division   The Compliance Division is responsible for ensuring that USGSA;appli-
                      cable provisions of the Agricultural Marketing Act of 1946; and regula-
                      tions, procedures, and policies issued under the acts are implemented
                      accurately and uniformly. Its responsibilities include

                      conducting operational reviews and program evaluations,
                      conducting investigations of alleged program violations,
                      implementing enforcement actions, and
                      administering other related regulatory programs.


                      FGIS’food safety and quality activities are conducted through its
Program Activities    national grain inspection and weighing system. These activities are dis-
                      cussed below under the following captions: inspection services, inspec-
                      tion and weighing activities, export activities, foreign grain complaints,
                      and relationship to state inspection programs.


Inspection Services   Official inspection is defined as the determination and certification by
                      official personnel of (1) the kind, class, quality, or condition of grain
                      under standards provided for in USGSA; (2) the condition of vessels and
                      other carriers or receptacles for the transportation of grain insofar as it
                      may affect the quality of such grain; or (3) other facts relating to grain
                      under other criteria approved by the FGIS Administrator.

                      FGIS offers three types of official grain inspection services, which differ
                      only in the way grain is sampled. Each type is identified by a certificate
                      of a specific color. Official Sample-Lot Inspection is the only one in
                      which official personnel licensed or employed by FGIS, using approved
                      equipment, obtain representative samples. The results, issued on a white
                      certificate, represent the entire lot inspected. This service is required for
                      export inspection and is available for domestic inspection. Under Ware-
                      house Sample-Lot Inspection, FGIS licenses grain elevator employees to
                      sample grain with approved equipment. The results, issued on a yellow
                      certificate, represent the entire lot inspected. For Submitted-Sample
                      Inspection, the applicant obtains and submits the sample. The official
                      personnel inspect the sample and issue a pink certificate. The results
                      issued represent only the sample submitted. All officially inspected sam-
                      ples are analyzed by trained official inspectors who are licensed or
                      employed by FGIS.

                      Other services available on request include (1) determinations of protein
                      in wheat, oil in sunflower seeds, protein and oil in soybeans, ethylene


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                          dibromide residues in grains and processed commodities, and aflatoxin
                          in corn; (2) stowage exams (made within 24 hours before loading) to
                          ensure that carriers are clean, dry, and fit for loading; and (3) equip-
                          ment testing to ensure accurate inspection results.


Inspection and Weighing   Under USGSA,exported grain, with few exceptions, must be officially
Activities                weighed. A similar requirement exists for inspection except for grain
                          which is not sold or described by grade. Grain exporters that export less
                          than 15,000 metric tons annually are exempt from the act’s mandatory
                          official inspection and weighing requirements, as is grain exported by
                          rail or truck to Canada or Mexico.

                          Mandatory services. During fiscal year 1989, FGIS provided mandatory
                          official inspection and weighing services, on a fee basis, at 61 export
                          grain elevators by about 550 FGIS employees. Also, 8 delegated states
                          with about 2,085 employees provided official services at an additional
                          27 export grain elevators under direct FGIS oversight.

                          Permissive services. Official inspection and weighing of U.S. grain des-
                          tined for domestic consumption, with few exceptions, are performed on
                          request and require payment of a fee by the applicant for the services.
                          In fiscal year 1989, domestic inspection and weighing services were pro-
                          vided by 77 designated state and private agencies. These agencies
                          employed about 4,210 personnel who were licensed by FGIS to provide
                          such services in accordance with FGIS regulations and instructions.

                          Inspection and standardization activities under the Agricultural Mar-
                          keting Act of 1946, which cover such commodities as flour and corn
                          meal, pulses, and rice, are performed on request and for a fee for both
                          domestic and export shipments either by FGIS employees or individual
                          contractors, or through cooperative agreements with states. Services
                          provided include plant sanitation inspections, aflatoxin testing, sam-
                          pling, checkweighing, checkloading, and quality analysis for various
                          commodities.

                          Establishments subject to inspection. During fiscal year 1989, FGIS
                          inspected 3 19 (about 40 percent) of the approximately 740 establish-
                          ments handling food products that were subject to FGIS inspection. All
                          facilities are not regularly inspected because inspection is required only
                          when an applicant requests FGIS services or when a contract requires the
                          inspection.



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Export Activities          During fiscal year 1989, about 630 inspectors were available for grading
                           export grain. About 280 were FGIS grain inspectors at export field
                           offices, and about 360 were employees of the 8 delegated states. During
                           the year, the inspectors performed services at 103 export service points
                           and graded 94,619 samples of exported grain.

..- .__..-..-I
Foreign Grain Complaints   In fiscal year 1989, FGIS received 24 quality complaints and 1 quantity
                           (weight) complaint. The tonnage involved in the complaints represented
                           about 0.9 percent, by weight, of the total amount of grain exported
                           during the year. The complaints involved allegations of heat damage,
                           infestation, and damaged kernels in wheat; broken corn and foreign
                           materials in corn; and the presence of aflatoxin in corn.


Relationsh.ip to State     In fiscal year 1989, the following eight states were delegated to provide
Inspection Programs        original inspection and weighing services under USGSAat export port
                           locations and were designated to provide official services under USGSAat
                           interior locations: Alabama, California, Minnesota, Mississippi, South
                           Carolina, Virginia, Washington, and Wisconsin.

                           In addition, 12 other states were designated to provide official services
                           under USGSAat interior locations only.

                           FGIS had agreements with 19 states, Puerto Rico, and Canada. The state
                           agreements involve inspection and sampling services performed by state
                           personnel. The Puerto Rico agreement involves rice inspection services
                           performed by Puerto Rico Commonwealth employees. The agreement
                           with the Canadian Grain Commission sets forth the conditions under
                           which FGIS official personnel will inspect U.S. grain in Canadian
                           elevators.


Funding Levels             interest on user fees. User fees fund FGIS’inspection and weighing activi-
                           ties, while federal appropriations fund FGIS’standardization and compli-
                           ance activities, international monitoring, and the FGIS Advisory
                           Committee.

                           For fiscal years 1984-89, about 82 percent of FGIS’total annual expendi-
                           tures were funded by user fees and about 18 percent by federal appro-
                           priations. Table 5.1 shows FGIS’appropriated and fee-supported
                           expenditures for fiscal years 1987 through 1989.


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Table 5.1: FOB’ Appropriated and Fee-
Supported Expenditurea, Fiscal Years        Dollars in Millions                                                                        II_-
1987-89                                                                                                       Fiscal year
                                            Exoenditures                                        1987              1988                        1989
                                            Appropriated funds                                   $6.7               $6.8                       $7.5
                                            Fe&supported funds                                   29.5               31.1                       34.0
                                            Total                                               $36.2              837.9                      $42.3
                                            Source: FGIS Annual Report to Congress, 1989.



                                            Table 5.2 shows FGIS' full-time permanent and part-time employee
Staffing Levels                             staffing at the end of fiscal years 1987 through 1989.

Table 5.2: FQIS Full-Time Permanent and
Part-Time Employee Staffing Level8 at                                                                         Fiscal year
End of Fiscal Years 198749                  Employee type                                       1987              1988 .__                    1989
                                            --1.-.,-Y--.-__

                                            Full-time permanent                                   690                709                        750
                                            Part-time                                             161                152                        110
                                            Total                                                651                 861                        660
                                            Source: FGIS budget data.

                                            As of September 30, 1989, FGIS had about 84 percent of its full-time
                                            employees and 91 percent of its part-time employees assigned to field
                                            locations. The remaining full-time employees (16 percent) and part-time
                                            employees (9 percent) were at headquarters.

                                            Table 5.3 shows FGIS full-time permanent staffing, expenditures, and
                                            inspection activities for selected fiscal years.

Table 5.3: FGIS Resources and
Inspection Activities, Fiscal Years 1980,                                                                     Fiscal year
1985, and 1989                              Description
                                            ___.-                                               1960                 1985                      1969
                                            Expenditures
                                            -._-._-..        (millions)                         $56.6               $38.5 ---~__- --          $42.3
                                            FGIS full-time permanent staffing                   1,778        .-.       739                       750
                                            Grain officially inspected (million metric tons)    278.5               269.1                     297.7
                                            Inspections/reinspections
                                                  . . --.                   (millions)            4.6       ---- _____ 3.0 __--..--.          ..---.2.8
                                            Protein
                                            - -_--.-__linspections   (thousands)                804.3               571.3                     528.6
                                            Aflatoxin inspections (thousands)                     4.3                 20.3                      49.2
                                            Source: FGIS




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                           During 1989, FGIShad 36 written cooperative agreements relating to
Coordination With          food safety and quality activities. At the federal level, it had 1 agree-
Other Federal              ment with a non-USDAagency--FDA-and 14 agreements with other USDA
Agencies                   agencies.

                           The agreement with FDA,which also is discussed in part 1, involves FDA’S
                           and FGIS' inspection and standardization responsibilities relating to
                           grain, rice, pulses, and food products at facilities that process, hold, and
                           distribute such products. FGIS has no authority to seize or detain these
                           products when it discovers anything that would endanger public health
                           during its inspections. Under this agreement, FGIS reports to FDAany lots
                           of these products which it considers to be actionable under the Federal
                           Food, Drug, and Cosmetic Act. Lots are actionable if they contain animal
                           or insect filth, toxic substances, objectionable odor, deleterious foreign
                           matter, nonapproved FDAadditives, or distinctly low-quality matter at
                           or above the defect action level.

                           FGIS' agreements with other USDAagencies, such as AMS (see part 4), ARS,
                           and APHISdeal with research, studies, and other services. For example,
                           FGIS has an agreement with USDA’S  Agricultural Stabilization and Conser-
                           vation Service under which FGIS performs contamination tests on
                           processed grain commodities for USDA’Sdomestic and foreign donation
                           programs. Another agreement between FGIS and ARS provides for cooper-
                           ation in research to develop a new wheat classification system.


                           According to FGIS, its critical food safety and quality issues of the 1990s
Critical Food Safety       include
and Quality Issues
Facing FGIS During     . providing top-quality services,
                       . retraining the current work force to use new testing technology,
the 1990s              l taking action to help prevent mycotoxin- and pesticide residue-contami-
                         nated grains from entering the market, and
                       l growing concern for better quality assurance by importers and domestic
                         buyers.

                           FGIS said that a primary concern is to provide top-quality service to ful-
                           fill its legislated responsibilities. Delivering such service depends on
                           well-trained and dedicated people and FGIS' ability to use the appro-
                           priate technology in the national inspection system.

                           E'GISstated that use of new testing methodologies will require retraining
                           the current work force, which relies heavily on human judgment in


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making subjective quality analyses. This is a long-term process and
offers the opportunity for FGISto recruit and develop employees in
underrepresented groups.

According to FGIS, new technology will enable FGISto better measure
grain quality in terms of intrinsic attributes as well as impurities and
contaminants, such as mycotoxins and chemical residues. Providing this
type of service will require further advances in quality control, an area
that is receiving a great deal of attention within the agency. According
to FGIS, it believes that as the ability to measure toxins and residues
improves, the pressure for the national inspection system to have a
direct role in regulating food safety will increase.

Also, FGIS senses a growing concern for better quality of grains and oil
seeds by importers and domestic buyers. FGIS studies indicate that
interest in specialized, intrinsic value, and end-use testing is growing.




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Part 6

National Marine Fisheries Service Activities                                                                 ’
Relating to SeafoodSafety and Quality

                             The National Marine Fisheries Service, National Oceanic and Atmos-
                             pheric Administration (NOAA), U.S. Department of Commerce, adminis-
                             ters two programs dealing with food safety and quality activities-the
                             voluntary National Seafood Inspection Program and the Product Safety,
                             Quality and Identity Research Program.


Major Legislation            laws discussed below.


Agricultural Marketing       The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et
Act of 1946, Fish and        seq.), authorized the Secretary of Agriculture to establish a voluntary
                             inspection and certification program for agricultural products, including
W ildlife Act of 1956, and   fish and shellfish, in interstate commerce through services made avail-
Reorganization Plan No. 4    able on a fee-for-service basis. The act also required the Secretary to,
of 1970                      among other things, conduct research and development of methods of
                             processing, packaging, handling, storing, and preserving products and
                             develop and improve standards of quality, condition, quantity, grade,
                             and packaging to encourage uniformity and consistency in commercial
                             practices.

                             Pursuant to the Fish and Wildlife Act of 1956 (16 USC. 742a et seq.),
                             IJSDA'S functions and authorities pertaining to commercial fisheries were
                             transferred to the U.S. Department of the Interior in 1958. The transfer
                             included the voluntary seafood inspection program. The act also author-
                             ized the Secretary of the Interior to improve production and marketing
                             practices. Reorganization Plan No. 4 of 1970 transferred the functions
                             described in the Fish and Wildlife Act of 1956, including the voluntary
                             seafood inspection program, from the Department of the Interior to
                             NOAA.



Lacey Act                    The Lacey Act, as amended (16 U.S.C. 3371 et seq.), makes it unlawful
                             to deliver, carry, transport, or ship by any means for commercial or non-
                             commercial purposes or sell in interstate or foreign commerce any fish
                             or wildlife that was taken, transported, or sold in violation of any fed-
                             eral, state, or foreign country’s law or regulation.




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Magnuson Fishery              The Magnuson Fishery Conservation and Management Act, as amended
Conservation and              (16 U.S.C. 1801 et seq.), requires fishery resources to be used to the
                              greatest overall benefit to the nation, with specific reference to the use
ManagementAct                 of the nation’s fishery resources as food. The act includes a mandate for
                              programmatic activities to, among other things, maximize the quality of
                              seafood products to ensure the greatest economic return for harvested
                              resources.


National Ocean Pollution      The National Ocean Pollution Research and Development and Moni-
Researchand Development       toring Planning Act of 1978 (33 U.S.C. 1701 et seq.) requires NOAA to
                              develop the necessary base of information to protect public health and
and Monitoring Planning       provide for the rational, efficient, and equitable conservation and devel-
Act                           opment of ocean and coastal resources.


                                     Office of Trade and Industry Services located at NMFS headquar-
Organizational Units          NMFS’
                              ters in Silver Spring, Maryland, supervises the Office’s Inspection Ser-
and Responsibilities          vices Division and the Utilization Research and Services Division. These
                              divisions are primarily responsible for executing NMFS' two food safety
                              and quality programs-the National Seafood Inspection Program and
                              the Product Quality, Safety and Identity Research Program. The NMFS
                              organizational units and their responsibilities under the two programs
                              are discussed below.


National Seafood              The Inspection Services Division, Office of Trade and Industry Services,
Inspection Program            conducts the National Seafood Inspection Program-a voluntary, fee-
                              based fish and shellfish products inspection and grading program. Divi-
                              sion employees inspect and certify plants and seafood products and
                              issue certification marks, including the Packed Under Federal Inspection
                              mark and/or U.S. Grade A mark.

                              The Division has three major units: Technical Services, Field Operations,
                              and the National Seafood Inspection Laboratory.

Technical Services Unit       The Technical Services Unit is responsible for

                          l   training NMFS inspectors, cross-licensed USDA and state inspectors, and
                              other interested parties;
                          l   providing education and information services related to the inspection
                              program;



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                                  developing product grade standards and federal purchase specifications;
                                  and
                                  participating with international organizations in developing and imple-
                                  menting international standards and codes of practice.

Field Operations Unit             The Field Operations Unit conducts the program’s day-to-day operations
                                  and services. The Unit’s activities include

                                  vessel and plant sanitation inspections,
                                  product inspection and grading, and
                                  product certification according to established specifications and criteria.

                                  The Unit has three inspection branches-the Northeast, in Gloucester,
                                  Massachusetts; the Southeast, in St. Petersburg, Florida; and the
                                  Western, in Bell, California. During fiscal year 1989, the branches main-
                                  tained eight satellite inspection offices, as follows:

                              . Northeast Inspection Branch: Rockland, Maine; New Bedford, Massachu-
                                setts; and Hampton, Virginia.
                              . Southeast Inspection Branch: Miami and Tampa, Florida; and Browns-
                                ville, Texas.
                              . Western Inspection Branch: Seattle and Bellingham, Washington.

National Seafood Inspection       The National Seafood Inspection Laboratory in Pascagoula, Mississippi,
L&oratory                         provides a variety of support services to the inspection program, such
                                  as

                              . performing laboratory analyses,
                              . executing various scientific research projects and new testing proce-
                                  dures, and
                              .   reviewing and approving labels and product specifications submitted by
                                  program participants to comply with applicable federal requirements.

                                  The Laboratory also prepares the semiannual “USDC Approved List of
                                  Fish Establishments and Products” and the quarterly “Inspection Con-
                                  nection” and mails them to all inspectors, program participants, buyers,
                                  and other interested parties.


Product Safety, Quality           The Utilization Research and Industry Services Division, Office of Trade
                                  and Industry Services, provides national coordination, oversight, and
and 1dentity”Research             evaluation of the Product Safety, Quality and Identity Research Pro-
Program                           gram. Program activities are carried out at three NMFS facilities:


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                         Charleston Laboratory in Charleston, South Carolina; Utilization
                         Research Division in Seattle, Washington; and Gloucester Laboratory in
                         Gloucester, Massachusetts.

                         The program provides services and information on impediments to the
                         full utilization of fishery resources. Activities include the collection,
                         interpretation, publication, and dissemination of information and
                         research results to facilitate optimum use of living marine resources.

                         Safety research includes activities that address the continuing concern
                         about the impact of environmentally and process-induced contamination
                         of seafood on consumers and the fishing industry. NMFS' quality research
                         efforts are directed to improving the overall quality of U.S. seafood mar-
                         keted domestically and internationally.

                                                                                                                   -
                         NMFS' food safety and quality activities relating to the National Seafood
Program Activities       Inspection Program and the Product Safety, Quality and Identity
                         Research Program are discussed below.


National Seafood         The following range of activities is performed by Inspection Services
Inspection Program       Division personnel for any financially interested party, including har-
                         vester, processor, food-service distributor, importer, and exporter:
Activities
                     l Vessel and plant sanitation inspection. NMFS inspects seafood in accor-
                       dance with the plant sanitation requirements established by FDA and
                       with Federal Standard 369, Sanitation Standards for Fish Plants.
                     l Product evaluation. NMF-Scan evaluate products in a processing facility
                       or a warehouse and can include evaluation for general condition, whole-
                       someness, proper labeling, and conformance with US. Standards for
                       Grades. In-plant evaluation of products during processing allows the use
                       of the Packed Under Federal Inspection and/or the U.S. Grade A marks
                       on the product label.
                     . Product specification and label review. Plants contracted for in-plant
                       inspection service submit product specifications and labels for NMFS
                       review and approval before use. NMFS reviews seafood for conformance
                       to FDA'S labeling requirements and proper use of food additives and the
                       inspection marks. This service is also available to nonparticipants as a
                       consultative service on a fee-for-service basis.
                     . Laboratory analyses. These analyses include microbiological tests, anal-
                       yses for chemical contaminants, index of decomposition, and species
                       identification.


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                    . Training. Training is available and has been provided to Department of
                      Defense quality assurance auditors and food inspectors, retailers, food-
                      service and plant personnel, and other interested parties. Subjects
                      include sanitation and employee hygienic practices, product evaluation
                      and grading, regulations, and preferred handling practices.
                    . Education/information. This activity may be in the form of presenta-
                      tions at scheduled events and through materials exhibits, publications,
                      press kits, and technical advice as requested by industry, consumers,
                      government agencies, fisheries trade associations, academia, retail, food-
                      service groups, and the media.

                      Another Inspection Services Division activity, although not considered a
                      direct part of the inspection service, is the development and/or amend-
                      ment of U.S. standards for grades and specifications. Appropriations
                      fund this activity.

                      NMFS activities and inspection data under the National Seafood Inspec-
                      tion Program are discussed below under the following captions: import
                      activities, export activities, establishments subject to inspection, dollar
                      value of food products subject to inspection, inspection data for 1981-
                      89, dollar value of food products subject to inspection, relationship to
                      state inspection programs, laboratory test data, and compliance
                      activities.

Import Activities     The Federal Food, Drug, and Cosmetic Act requires that imported sea-
                      food products meet the basic requirements imposed on comparable items
                      produced by U.S. processors for interstate commerce. All imports of sea-
                      food products are subject to FDA sampling, inspection, and analysis at
                      the port of entry. FDA port-of-entry inspection determines whether prod-
                      ucts meet existing requirements regarding wholesomeness, labeling, tol-
                      erances for pesticide residues, and food additives.

                      Most imported fishery products that NMFS lot* inspects upon request are
                      inspected for compliance with buyer specifications, after FDA accepts the
                      products into the United States. NMFS performs analyses for microorga-
                      nisms, species identification, and chemical additives when there is a sus-
                      picion of noncompliance or at the request of the requesting party.

                      NMEX’ lot
                              inspection certificate is the official document used for import
                      and domestic lot inspection certification. Since import and domestic lot

                      ‘“Lot” generally means a pile of similar containers containing a similar type of processed product
                      which is separated or marked differently from other piles in the same warehouse.



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                                      inspections are not segregated, the volume of lot-inspected imported sea-
                                      food is not known,

                                      Import and export inspection services can be provided by any NMFS or
                                      NMFS cross-licensed inspector at any of its offices, the port of entry, or a
                                      designated warehouse. As of January 1990, there were 144 NMFS inspec-
                                      tors, 63 NMFS cross-licensed federal (USDA) inspectors, and 74 NMFS cross-
                                      licensed state inspectors. There are 10 NMFS lot inspection offices, 10
                                      NMFS cross-licensed state lot inspection offices, and 4 NMFS cross-licensed
                                      USDA lot inspection offices.

Export Activities                     NME'Sconducts inspection and analyses of fishery commodities for export
                                      and issues official U.S. government certificates attesting to the findings.
                                      Certification for compliance of exported products can be provided for
                                      foreign requirements, where known, or on the basis of specifications set
                                      by the exporter.

                                      Table 6.1 shows the number of export inspection certificates issued for
                                      1984 through 1989. They represent the minimum number of inspections,
                                      since the certificates often represent more than one inspection,

Table 6.1: NMFS Export Inspection
Certificates Issued, Calendar Years   Year                                                        Export inspection certificates   issued
                                              --            ____-.                                                           __..------
1984-89                               1984 --_-. --~..--~_ ___-                                                                      1,916
                                      ----.~-                                         .-__
                                      1985
                                      _~-~-.-  ------.._-.-        .______.                                                          1,930
                                      1986                                                   -~                                      2,714
                                      1987
                                      _ ..~__- -..-~-- _.--~                  ___._                                                  4,217
                                      1988                                                                --    ._.--      -..- - -~~.4,283
                                                                                                                                        .-.-
                                      1989                     ~..__   -___                                                __-     .._ 2,469
                                                                                                                                         .~~__
                                      Total                                                                                         17.529
                                      Source: NMFS


Establishments Subject to             According to “Fisheries of the United States, 1988,” there were 1,878
Inspection                            processing plants in 1987. Of those plants, an average of 141 plants
                                      (about 7.5 percent) were contracted for NMFS inspection services that
                                      year. This figure does not reflect the number of inspections performed
                                      on a noncontract basis (e.g., lot inspections).

Inspection Data for 1981-89           Table 6.2 shows the pounds of domestic and imported fishery products
                                      inspected for 1981 through 1989, classified by type of inspection.




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Table 6.2: NMFS-Inspected Flshery
Products, Calendar Years 1981-89         Pounds in millions
                                                                           In-plant                                  Lot
                                         Year                  Grade A         PUFP     No Mark              Domertic        Exoort       Total
                                          1981                     110          366           43                     49          56        825
                                         1982                       95          305           64                     41          64        589
                                         1983                       92          315           64                     41          54        587
                                         1984                      100          244           59                     34          47        484
                                         1985
                                         __----                    118          193           47                     40          44        443
                                         1986
                                         .-__                      128 -        192           38                     41          44        442
                                         1987                      113          199           33                     33          54        433
                                         1988
                                         ~--_-~.~                  106          198           58                     40          93        495
                                         1989                      117          190           81                     60         114        583
                                         aPacked Under Federal Inspection
                                         Source: NMFS.


Dollar Value of Food Products            No data are available on the value of food products that were inspected
Subject to Inspection                    by the National Seafood Inspection Program, However, table 6.3 shows
                                         data on the value of domestic and imported edible processed fishery
                                         products for 1980 through 1988.

Table 8.3: Value of Edible Processed
Fishery Products, Calendar Years 1980-   Dollars in millions
88                                       ----_
                                         Year
                                         _--.                      Fresh/frozen             Canned                  Cured                 Total
                                         1980           ----___             $2,110            $1,804                 $125               $4,039
                                         1981                                2,527             1,878                  135                4,540
                                         1982                                2,521             1,325                  143                3,988
                                         1983          ~--                   3,124             1,394                  159                4,677
                                         1984                                3,234             1,436                  165                4,835
                                         1985
                                         ------                     -        3,257             1,302                  168                4,727
                                         1986           ___----              3,481             1,395                  110                4,986
                                         i987
                                         --                ---__             4,041             1,476                  136                5,654
                                         1988                                3.562             1.385                   94                5.040
                                         Source:NMFS

Relationship to State Inspection         Generally, NMFS' interaction with state inspection programs is through
Programs                                 cooperative agreements relative to voluntary inspection services for fish
                                         and fishery products. Under the agreements, NMFS provides training to
                                         state inspectors who are certified to perform NMFS inspection activities
                                         and monitors state inspection activities through interaction with the
                                         states’ managing offices. NMFS does not provide federal grants to states
                                         for providing inspection services on behalf of NMFS. Rather, it reim-
                                         burses the states for their costs, at an agreed-upon hourly rate. As of


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                                           May 1990, NMFS had agreements with the following 12 states: Alabama,
                                           Alaska, Arkansas, Florida, Louisiana, Minnesota, Mississippi, New
                                           Jersey, New York, Oregon, Tennessee, and Washington.

Labaratmy Test Data                        Table 6.4 shows the number and type of laboratory tests conducted at
                                           the National Seafood Inspection Laboratory for fiscal years 1981
                                           through 1989, classified by type of test-microbiological, chemical, and
                                           physical.

Table 6.4: NMFS Laboratory Tests, Fiscal
Years 1981-89                              Year                           Microbiological       Chemical         Physical               Total
                                                                   ---
                                           -1981--..__                                  75             35                5               115
                                            1982____..
                                            __._..."  -__..__
                                                           -. _ ----___                 69             28                7               104
                                            1983                                        70              6                2                78
                                            1984                                        71              7                6                84
                                           1985                                         39              9               11                59
                                           1986          -__                            43             23                5         --     71
                                           1987                                         51             20               14                85
                                           1988              _ __--                     68             22               15               105
                                                                                                                                         __
                                           1989                                         33             25                8                66
                                           Source: NMFS


Compliance Activities                      Compliance activities for participants in the voluntary seafood inspec-
                                           tion program would include, for example, determining a plant’s compli-
                                           ance with sanitation standards. In cases of noncompliance, NMFS notifies
                                           appropriate plant personnel to take corrective action. If continued non-
                                           compliance occurs, NMFS suspends services. Because of the program’s
                                           voluntary nature, formal suspension is seldom required; the noncom-
                                           plying plant withdraws from the program of its own accord. When con-
                                           ditions at a plant are such that a potential safety or health concern
                                           exists, NMFS contacts the appropriate state agency and/or FDA to follow
                                           up on items that are unresolved.

                                           Because of the program’s voluntary and quality-oriented nature, the
                                           most common reason for NMFS to take formal suspension action is the
                                           result of nonpayment of inspection services. In fiscal year 1988, five
                                           plants were suspended-four for nonpayment and one for continued
                                           sanitation noncompliance. In fiscal year 1989, four plants were sus-
                                           pended, all for nonpayment.




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Product Safety, Quality       NMFS carries out the following types of food safety and quality activities
and Identity Research         under its Product Safety, Quality and Identity Research Program:
Program Activities        . Seafood safety research. This research produces, collects, interprets,
                            and disseminates information on the identity, level, toxicology, risk, and
                            public health significance of hazardous environmental contaminants
                            found in seafoods. These include natural biotoxins, heavy metals, petro-
                            leum hydrocarbons, synthetic organic chemicals, viruses, fungi, and bac-
                            teria. The information is used to design and/or improve existing seafood
                            inspection, industry quality control, and fishery management programs
                            to protect consumers from seafood hazards and the industry from
                            unwarranted adverse publicity and perception problems.
                          . Microbiological safety research, This research’s purpose is to increase
                            the safety and marketability of fishery products by identifying the
                            hazards and critical control points of processing and storage in relation
                            to growth of food-poisoning organisms and to develop process parame-
                            ters for inhibiting or destroying Clostridium botulinurn and Listeria
                            monocytogenes, the causative agents of the diseases botulism and listeri-
                            osis, respectively.
                          . Molluscan shellfish research. This research produces, collects, inter-
                            prets, and disseminates information on the identity, level, risk, and
                            public health significance of hazardous microbial (viruses, bacteria, and
                            fungi) contaminants found in molluscan shellfish. The information is
                            used to design and/or improve existing shellfish purification technolo-
                            gies, shellfish inspection, industry quality control, and fishery manage-
                            ment programs.
                          . Fishery chemistry research. This research includes development of spe-
                            cies identification methodology on the basis of biochemical and immuno-
                            logical techniques. Studies are done on the (1) nature of textural change
                            in frozen fish; (2) effects of handling, storage, and processing on the
                            quality of seafoods; (3) development of nutritional data relating to fresh
                            and processed seafoods; (4) analyses of samples of food fish for organic
                            contaminants; and (5) development of a new methodology for microcon-
                            taminant analysis.
                            Fishery technology research. This research includes technology transfer
                            for fishery development programs and the application of technological
                            advances to the quality assurance of fresh and frozen seafoods.
                            Underutilized species research. This research is conducted on use con-
                            cepts, preservation, and quality assurance of underutilized species. It
                            addresses quality; composition; preservation; handling; processing
                            safety; and nutritional, functional, and edibility characteristics of spe-
                            cies of fish that are not currently utilized because of marketing
                            impediments,


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-
                 l Biomedical test materials program. This program produces fish oil test
                   materials which are provided to researchers approved by the National
                   Institutes of Health and the Alcohol, Drug Abuse, and Mental Health
                   Administration to conduct long-term clinical studies, basic biochemical
                   investigations, and animal-feeding studies necessary to determine the
                   nutritive, therapeutic, and preventative effects of omega-3 fatty acids of
                   marine origin.
                 l Oil-tainted fish. This initiative focuses on addressing the issues associ-
                   ated with preventing the marketing of oil-tainted fish that resulted from
                   the Alaska oil spill.
                 . Input to Codex Alimentarius. NMFS provides coordination and technical
                   input for U.S. participation in Codex, which develops (1) international
                   technical standards of minimum quality and identity for fish and
                   fishery products and (2) codes of hygienic and technological practice.
                 . Technical support to law enforcement personnel. Law enforcement per-
                   sonnel sometimes need technical support while pursuing threatened and
                   endangered species and fishery management law violations as well as
                   state game fish violations. An example of technical support provided
                   includes verifying the causes of death of marine mammals suspected of
                   dying from ingestion of fin fish containing naturally occurring biotoxins.
                   Since these finfish can also be used for food, the implications of these
                   biotoxins to human risk is also of concern.
                 . Extramural research and development. Extramural research and devel-
                   opment activities are achieved through cooperative agreements. A por-
                   tion of this effort focuses on seafood safety, quality, and identity tasks
                   that complement the NMFS in-house research program.


                     NMFS' food safety and quality activities are funded through a combina-
Funding Levels       tion of appropriated funds and user fees (reimbursable costs). Federal
                     appropriations generally fund the Product Safety, Quality and Identity
                     Research Program and the standards, specifications, and laboratory ser-
                     vices provided under the National Seafood Inspection Program. User
                     fees generally fund the inspection and grading services provided under
                     the National Seafood Inspection Program. Table 6.5 shows the appropri-
                     ated funds and reimbursable costs for the two programs.




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Table 6.5: Funding of NMFS Food Safety
and Quality Activities, Fiscal Years 1988-   Dollars in thousands
89                                                                   _-.- .--__               Appropriated       -                Reimbursable
                                             Activity                                         1988       1989
                                                                                                           -__..                  1988    _~..1989
                                                                                                                                               ..-
                                             Inspection program
                                                Inspection/grading                               $0            $0                $4,402      $5,096
                                                Standards/specifications                        173
                                                                                     .___1,4__--~---_--_--_~_ 190                     0
                                                                                                                                   ___-.    ~~-~ ~.0
                                                Laboratory                                                   706                      0               0
                                             Subtotal                                          887           ___--
                                                                                                             898                 4,402        5,096

                                             Research program                                                                               .~.._~~
                                               Charleston Laboratory                          3,6*3 .--.-3,020      ..~---~-o-                     0
                                               Seattle Laboratory                             1,173        1,381                      0               0
                                               Gloucester Laboratory                          1,006          980                      0               0
                                               Headquarters
                                             Subtotal                                          303
                                                                                             6,165            253 -.--.-
                                                                                                _....-...-__5,634..-‘            ..~-o-0   .~- -. o0

                                             Total                                           $7,052       $6,530                 $4,402      $5,096
                                             Source: NMFS.

                                             For fiscal year 1988, the two programs’ costs totaled about $11.5 mil-
                                             lion, of which about 62 percent was funded by federal appropriations
                                             and about 38 percent by user fees. Federal appropriations funded all of
                                             the research program and 17 percent of the inspection program costs.

                                             For fiscal year 1989, the programs’ costs totaled about $11.6 million, of
                                             which about 56 percent was funded by federal appropriations and about
                                             44 percent by user fees. Federal appropriations funded all of the
                                             research program and 15 percent of the inspection program costs.


                                             Table 6.6 shows the staffing levels for the two programs for fiscal years
Staffing Levels                              1988 and 1989.




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Table 6.6: Staffing Levels for NMFS’
Food Safety and Quality Activities, Fiscal                                                                                     Staffing-level
Years 1988-89                                Program/organizational             unit                                       1988                        1989
                                                                                    ~--I_.
                                             Inspection Program
                                                            ~__        ----..p.;           _... ___-_--..--.---
                                                Headquarters -.-- - _-~~__ -...__..~._____~                             6
                                                                                                                ._________....         -_ _~~..        -.~- 7
                                                Northeast Inspection Branch                                            45                                 46
                                               sou!~.~~.!n~~~~~~~~~~----_-_~..----.                         -..---2_----                  .._      _     31
                                               Western Inspection Branch                                                     37                          39
                                               Technical Services Unit                                                        5                            5
                                               National Seafood
                                             subtotai     ~..~~..~~Inspection
                                                                      ~~~~~~ Laboratory                                      31                          35
                                                                                                                            162                        163

                                             Research Program
                                               Charleston Laboratory                                                         47                          51
                                               Seattle Laboratory                                                             25                         22
                                               Gloucester    Laboratory
                                              -_.._..--.-__.-_-.-......_
                                                                       ~-.--.     ----..--     __._ ~-~.._.-.__-              23
                                                                                                                       ._.._._.__.   ~~_....- __       .~23
                                                                                                                                                         ..~~
                                               Headquarters                                                                    7                          6
                                             Subtotal                                                                       102                        102
                                             Total                                                                           264                       265
                                             Source: NMFS.



                                             During fiscal year 1989, NMFS had seven written cooperative agreements
Coordination With                            or memorandums of understanding with other federal agencies-four
Other Federal                                with IJSDA, three with FDA, and one with the Defense Logistics Agency-
Agencies                                     to coordinate its food safety and quality activities. The general sub-
                                             stance of each agreement is described below.

                                             One of the four agreements with USDA establishes NMFS and USDA respon-
                                             sibilities relating to the research and development of standardization
                                             documents for fishery products purchased by federal agencies. The
                                             other three provide for cross-licensing employees of the two agencies to
                                             perform inspection and certification services pursuant to the Agricul-
                                             tural Marketing Act of 1946. Under the act, NMFS and USDA perform sim-
                                             ilar inspection and certification services on behalf of the other agency-
                                             using cross-licensed inspectors -for industry applicants on a fee-for-
                                             service basis for fishery and agricultural products.

                                             One memorandum of understanding with FDA covers fishery products
                                             plants that are under NMFS voluntary inspection contracts and also sub-
                                             ject to FDA inspection. The agreement is described in part 1. Another
                                              NMK memorandum of understanding with FDA relates to research pro-
                                             grams for fishery products. The agreement’s purpose is to improve and


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                           increase the cooperation/coordination of research efforts, avoid duplica-
                           tion of effort, and make more efficient use of federal resources sup-
                           porting fishery products research programs that are of joint interest to
                           the two agencies. Research areas included in the agreement cover activi-
                           ties of mutual concern related to the safety, quality, nutrition and
                           labeling requirements for fish and shellfish products, Meetings have
                           been held semiannually since 1981 to (1) focus and prioritize the needs
                           for continuing research, (2) plan research projects for joint execution,
                           and (3) share results of completed research.

                           NMFS' other memorandum of understanding with FDA concerns the
                           enforcement of laws against illegal commerce in molluscan shellfish.
                           NMFS advises FDA when investigations reveal illegal shellfish harvesting
                           that would endanger public health by harvesting shellfish from polluted
                           waters. Both NMFS and FDA coordinate their activities under the memo-
                           randum of understanding with the public health and fisheries agencies
                           of interested and affected states.

                           NM&   memorandum of understanding with the Defense Logistics Agency
                           authorizes NMFS to inspect and certify fish and fishery products pur-
                           chased by the Defense Logistics Agency for compliance with quality
                           assurance requirements in published standards and contract
                           specifications.


                           According to NMFS, potential consumer hazards in seafoods can be classi-
Critical Food Safety       fied into three categories: product safety, plant and food hygiene, and
and Quality Issues         economic fraud. Causative agents of public hazards in seafood are either
Facing NMFS During         environmental (natural or manmade), process, or distribution induced.
                           NMFS stated that it faces the following critical food safety and quality
the 1990s                  issues:

                       9 Pollutants and contaminants.
                       l Biotoxins in finfish and molluscan shellfish.
                       l Cleansing of contaminated molluscan shellfish.
                       . Potential hazards associated with new processing, packaging, and mar-
                         keting techniques.
                       l Decomposition indicators and international acceptance.
                       l Economic fraud.
                       l Equivalence of food control systems.
                       . Seafood inspection.
                       l Water conservation and reuse.



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Pollutants and             Fish and shellfish accumulate varying degrees of pollutants, petroleum
Contaminants               hydrocarbons, and synthetic organic compounds (e.g., pesticides) that
                           enter the environment through agricultural and industrial activities and
                           disposal of wastes. These pollutants affect animal health and fishery
                           resources’ability to reproduce, and enter into human food supplies. Sea-
                           foods-shellfish in particular-may     also harbor pathogenic bacteria
                           and viruses originating largely from human and animal waste at levels
                           that can cause illness to consumers. According to NMFS, the impact of
                           these contaminants will increase dramatically as the human population
                           on the coasts continues to grow faster than waste/run-off management
                           can be implemented.

                           Pollution of coastal and offshore fishing grounds has resulted in inter-
                           mittent closures of some areas to both finfish and shellfish harvesting.
                           NMFS believes that without long-term planning for control in concert
                           with coastal states, the nation’s fish stocks are being jeopardized. The
                           safety of consuming fish from these areas or marginally contaminated
                           waters is not well understood. The likelihood of human exposure to
                           these pollutants depends on their physical, chemical, and biological
                           form; concentration; and persistence or survival. The character and
                           nature of environmental pathways leading to human exposure are also
                           important variables.

_____-
Biotoxins in Finfish and   Toxins in finfish and molluscan shellfish (clams, oysters, mussels, and
Molluscan Shellfish        scallops) have increasingly been implicated in human health disorders.
                           According to the Centers for Disease Control’s records for 1983-87, cig-
                           uatera and scombroid poisoning were the first and second most fre-
                           quently reported illnesses associated with eating fish. In addition to
                           consumer safety issues, toxins pose a severe economic threat to the
                           shellfish industry.

                           The significance of other toxins (domoic acid, paralytic shellfish
                           poisoning, and diuretic shellfish poisoning) and toxin presence and
                           bloom evolution require investigation of the dynamics of toxin uptake,
                           discharge, and/or removal by individual species. Detection methodology
                           appropriate to industry needs also requires development. Research
                           results and technology must be transferred to the industry to facilitate
                           resource access and use. In addition, monitoring is required to prevent
                           contaminated products from being introduced into the market.




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Cleansing of Contaminated    NMI~S said that the depuration (cleansing) process, as currently prac-

Molluscan Shellfish          ticed, may not be an effective technology in eliminating all viral agents
                             from molluscan shellfish in a timely manner. Certain viral agents show
                             distinctly different and prolonged elimination rates in shellfish relative
                             to bacterial indicators. According to NMFS, critical information is missing
                             about the depuration of viral agents in shellfish, and controlled studies
                             have been hindered by a lack of methods to enumerate these particles in
                             shellfish. In addition, there is a paucity of information on the elimina-
                             tion of chemical contaminants from shellfish. Limited studies addressing
                             heavy metals elimination rates indicate that metals remain high in depu-
                             rating products for extended months.


Potential Hazards            NMFS stated that considerable data are available on older, “time-tested”

Associated With New          methods of processing and marketing fishery products. However,
                             increased consumer interest in fishery products and foreign trade oppor-
Processing, Packaging, and   tunities have inspired altering these methods, introducing new
Marketing Techniques         processing techniques, and developing new value-added products. Many
                             of these procedures inactivate the normal spoilage flora, which in turn
                             increases the products’ shelf-life.

                             NME‘S stated that new food processing and packaging technology may
                             have a profound effect on safety and quality. Food processing, irradia-
                             tion, shellfish depuration, innovative product treatments and additives,
                             manufacturing imitation seafoods, vacuum and modified-atmosphere
                             packaging, and home use of microwave food preparation are some items
                             sure to receive increased continued review by public health agencies.

                             According to NMFS, unless adequate processing procedures are followed
                             and/or inhibitors of bacterial pathogens are present in the fishery
                             product, potential hazards can develop during distribution or at the con-
                             sumer level through food poisoning outbreaks, causing illnesses and
                             occasionally death. A baseline of knowledge on new processing, pack-
                             aging, and marketing strategies and the potential risks introduced
                             requires investigation and consensus among food control authorities on
                             a list of priority research that should be undertaken.


Decomposition Indicators     Seafood decomposition action levels, which result in rejection or deten-
and International            tion during inspections, are not available for many seafoods domesti-
                             tally and are not internationally uniform. NMF-S said that a need exists to
Acceptance ”                 reassess current decomposition action levels, develop new ones where



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                      they are absent, and align them with international indexes of minimum
                      quality for consumer protection and trade purposes.


Economic Fraud        Economic fraud is the intentional or unintentional misrepresentation of
                      a product as a higher value item than it truly is. Examples of economic
                      fraud include species substitution, overbreading of breaded seafoods,
                      and short net weights of frozen products sometimes caused by including
                      the weight of the protective coating of ice as part of the net weight. NMFS
                      believes that these practices can be eliminated by developing an effec-
                      tive monitoring and compliance system for each commodity.


Equivalence of Food   NMFS stated that public health and safety problems related to seafood
Control Systems       consumption are complicated by the fact that over 60 percent of total
                      IJS. seafood consumption is of seafood imported from over 125 coun-
                      tries. NMFS believes that better assessment and control of consumer
                      hazards in overseas processing and products need to be addressed in any
                      future seafood regulation program. Such controls may be accomplished
                      by providing assistance to countries in developing food control systems
                      that are determined to provide public health and safety protection
                      equivalent to the U.S. system. According to NMFS, flexibility and
                      capacity to address these different needs and controls will need to be
                      built into legislation that addresses mandatory seafood inspection.


Seafood Inspection    NMFS said that a major factor affecting seafood safety and quality is the
                      inspectional approach to food system control. Plant hygiene (sanitation)
                      and food hygiene (wholesomeness) are directly related to operational
                      and food-handling practices from fishery harvest through processing
                      and distribution. For the large part, the food industry has been depen-
                      dent on outdated control concepts, such as continual on-site inspection
                      (used for meat and poultry) and duplicative federal, state, and local reg-
                      ulation and enforcement activities.

                      NMFS believes that under the Hazard Analysis Critical Control Point
                      approach recommended in 1985 by the National Academy of Sciences,
                      the industry must take the lead to define each operational step of a
                      processing operation, indicate the hazard and relative importance of
                      each step, identify the critical control points for the significant hazards,
                      define preventive measures to minimize the hazard, and detail the moni-
                      toring procedures (observation or measurement) that can be used for



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                         compliance procedures. Each step in the food flow system can be
                         defined, and decisions on reasonable and effective controls can be made.

                         NOAA’S Model Seafood Surveillance Project is conducting workshops on a
                         commodity-by-commodity basis. Workshop participants exalmine the
                         hazards associated with their products’ end use and develop a food con-
                         trol model, on the basis of the Hazard Analysis Critical Control Point
                         approach, applicable to their industry.

                         After such an industry-driven system is developed, regulatory authori-
                         ties have the opportunity to assess the appropriateness of selected crit-
                         ical control points, monitoring procedures, record-keeping requirements,
                         and corrective action to verify that the system is effective in eliminating
                         public health and safety hazards.


Water Conservation and   Adequate water of acceptable quality is often a critical item in seafood-
Reuse                    processing facilities. NMFS believes that clean-up measures to ensure that
                         recycled water is safe and suitable for food contact are essential to con-
                         trol contamination and the spread of foodborne illness agents.




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Part 7’

Other SelectedFederal Agencies Involved With
Food Safety md Quality Activities

                            In addition to the six principal federal agencies discussed in parts 1
                            through 6 of this report, a number of other federal agencies carry out
                            food safety and quality activities. In this section, the following agencies’
                            food safety and quality activities are discussed briefly:

                        l   Agricultural Research Service, USDA;
                        9   Animal and Plant Health Inspection Service, USDA;
                        .   Bureau of Alcohol, Tobacco and Firearms (ATF), Department of the
                            Treasury;
                        .   Centers for Disease Control (CDC), Public Health Service, Department of
                            Health and Human Services;
                        l   Federal Trade Commission (FTC);and
                        .   United States Customs Service, Department of the Treasury.

                            For these agencies, information similar to that for the six principal agen-
                            cies is presented, but in less detail. Also, we gave each agency the option
                            to provide information on what they considered to be the critical food
                            safety and quality issues of the 1990s. Three of the six agencies-ARs,
                            APHIS, and CDC-chose to provide information on issues.


                            ARS' mission is to develop new knowledge and technology which will
Agricultural Research       help ensure an abundance of high-quality agricultural commodities and
Service                     products at reasonable prices to meet the increasing needs of an
                            expanding economy and to provide for the continued improvement in
                            the standard of living of all Americans.


Major Legislation           AI% carries out food safety and quality research activities pursuant to
                            the Department of Agriculture Organic Act of 1862 (7 USC. 2201 et
                            seq.); the Research and Marketing Act of 1946, as amended (7 U.S.c 427
                            et seq.); and the National Agricultural Research, Extension, and
                            Teaching Policy Act of 1977, as amended (7 USC. 3101 et seq.).


Organization and            Am    headquarters is located in the Washington, D.C., area. Its field activ-
Responsibilities            ities are managed through 8 area offices and are carried out at 126 sepa-
                            rate field locations.

                            Am is responsible for conducting a wide range of research relating to
                            IJSDA'S mission, including research to assure food safety and quality for
                            the nation’s consumers. Much of ARS' food safety and quality activities
                            are performed at the following ARS research laboratories and centers:


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                                                                                                             .
                              Other Selected Federal Agencies Involved
                              Wlth Food Safety and Quality Activities




                          . Beltsville Agricultural Research Center, Beltsville, Maryland.
                          . Eastern Regional Research Center, Philadelphia, Pennsylvania.
                          . Meat Animal Research Center, Clay Center, Nebraska.
                          . National Animal Disease Center, Ames, Iowa.
                          l National Peanut Research Laboratory, Dawson, Georgia.
                          l Northern Regional Research Center, Peoria, Illinois.
                          . Poisonous Plants Research Center, Logan, Utah.
                          l Richard Russell Research Center, Athens, Georgia.
                          l Southern Regional Research Center, New Orleans, Louisiana.
                          . Food Animal Protection Research Laboratory, College Station, Texas.
                          l Western Regional Research Center, Albany, California.


Program Activities            A&   food safety and quality activities include the following:

                          . Developing methodologies to detect and control bacterial and parasitic
                            contamination of meat and poultry and their products, including the
                            control of salmonella and campylobacter in live animals.
                          . Developing methodologies to identify and detect chemical residues (of
                            drug, pesticide, or fungal origin) of concern in meat and poultry and
                            their products, including the development of pharmacokinetic models of
                            drug metabolism in food animals.
                          . Developing methodologies to detect mycotoxins in plant commodities
                            and to prevent mycotoxin infestation in the field.


Funding and Staffing          During fiscal year 1989, ARS had about $606 million available for its pro-
                              grams and used about $25.2 million (about 4 percent) for food safety
Levels                        and quality activities.

                              As of September 30, 1989, ARS had a total of 6,947 full-time employees
                              and 1,624 other than full-time employees. Of the total, 453 (about 7 per-
                              cent) of the full-time employees and 30 (about 2 percent) of the part-
                              time employees worked in central offices in the Washington, D.C., area.

                              During fiscal year 1989, ARS used about 168 scientists years on food
                              safety and quality activities.


Coordination With Other       Within USDA, ARS coordinates its food safety research with the Food
                              Safety and Inspection Service, the Federal Grain Inspection Service, and
Federal Agkncies              the Agricultural Marketing Service. ARS also coordinates its research



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                              with other federal agencies, primarily EPA and FDA. ARS achieves its coor-
                              dination through a combination of formal memorandums of under-
                              standing, designated formal liaisons, informal working relationships,
                              and joint workshops.


Critical Food Safety and      ARS provided the following list of items it believes will be critical food
Quality Issues of the 1990s   safety and quality issues of the 1990s:

                          l   Development of control methods for bacteria such as salmonella and
                              campylobacter in meat and poultry products.
                          .   Development of control methods for hazardous bacteria in combination
                              meat and vegetable products.
                          .   Development of technology to detect and reduce chemical pesticide use.
                          .   Control of aflatoxin and other mycotoxins in field crops and tree nuts.
                          .   Control of both hazardous microorganisms and residues to meet the
                              needs of export.


                              APHIS’mission is to provide leadership in ensuring the health and care of
Animal and Plant              animals and plants, to improve agricultural productivity and competi-
Health Inspection             tiveness, and to contribute to the national economy and the public
Service                       health.



Major Legislation             APIIIS stated that it has not had legal responsibilities to protect or pro-
                              mote food safety and quality. According to APHIS, it has no statutory
                              authority to perform food safety activities unless the organism or chem-
                              ical of concern to public health is also of concern to animal or plant
                              health. However, APHIS added that certain APHIS animal health programs
                              do affect food safety. Programs designed to protect the animal industry
                              against pathogens or diseases that can pose foodborne risk to humans
                              also improve food safety. For example, during 1990, APHIS had an emer-
                              gency program in operation against salmonella enteritidis in poultry.
                              Under the program, APHIS tests and monitors all egg-type breeding and
                              multiplier flocks, as well as controls the interstate movement of poultry,
                              eggs, and material from known culture-positive flocks and exposed
                              flocks.

                              Also, APHIS stated that certain of its plant health programs indirectly
                              affect food safety. Chemicals and natural toxins are primary food safety
                              concerns for plant-food commodities. APHIS programs leading to reduced


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                         chemical applications, such as Integrated Pest Management or biological
                         control strategies, reduce pesticide use.


Organization and         AI’IiIS headquarters is located in the Washington, D.C., area. During fiscal
Responsibilities         year 1989, field activities were carried out by 10 regional offices and
                         119 field offices. Much of APHIS’work is conducted in cooperation with
                         state and local agencies, private groups, and foreign governments.

                         In the field, APHIS maintains an infrastructure of animal and plant health
                         specialists throughout the United States who deal with producers and
                         are responsible for addressing animal and plant health mandates.

                         APHIS stated that its animal and plant health programs aim to protect the
                         health of animal and plant resources. It added that although its current
                         programs are not designed to directly address food safety objectives, it
                         could become more active in addressing these issues in the future. APHIS
                         stated that it recognizes that effective food safety protection must begin
                         on the farm-at the beginning of the food production process. It said
                         that producers must accept responsibility and accountability for their
                         products prior to their entry into, and subsequent movement through,
                         the market chain.

                         APIIIS   also stated that its field infrastructure might support a future
                         APHIS role of assisting producers in developing production practices and
                         monitoring systems for food commodities, including disease prevention
                         strategies consistent with food safety objectives.

-___
Program Activities       APIIIS carries out its mission, in part, by performing the following types
                         of activities:

                     l   Plant disease and pest control. In cooperation with states, APHIS carries
                         out surveys to detect harmful pests and diseases, inspections to prevent
                         the spread of plant pests to noninfested areas of the country, and pro-
                         grams to eradicate new or established plant pests and diseases. APHIS
                         conducts an inspection program at ports of entry to prevent the intro-
                         duction of foreign plants and animal pests and disease which are
                         harmful to agriculture in the United States. APHIS also certifies plants
                         and plant products for export and regulates imports and exports of
                         endangered plant species.
                     l   Animal disease and pest control. In cooperation with states, APHIS con-
                         ducts programs to (1) prevent communicable diseases of foreign origin


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                              from entering the United States; (2) diagnose foreign animal diseases,
                              should they enter the country; and (3) prevent the spread of diseases
                              through interstate shipments of livestock or distribution of impure,
                              unsafe, impotent, and nonefficacious veterinary biologics. APHIS con-
                              ducts other programs to control and eradicate livestock diseases present
                              in the United States.

- ----_-__
Funding and Staffing          APHIS stated that although many of its programs indirectly affect food
Levels                        safety, total APHIS funding and staffing level data for these programs are
                              inaccurate measures of its “food safety resources.”

                              The total amount available to APHIS for fiscal year 1989 was about $369
                              million, including about $341 million of appropriated funds and about
                              $28 million in reimbursements.

                              As of September 30, 1989, APIIIS had 4,873 permanent full-time
                              employees and 1,019 part-time employees. Of the total, 725 (about 15
                              percent) of the full-time employees and 85 (about 8 percent) of the part-
                              time employees worked in central offices in the Washington, D.C., area.

--l__-.--__-__
Coordination With Other       In the area of animal health, APHIS cooperates with and responds to
Federal Agencies              reports from USDA’S Food Safety and Inspection Service, FDA, and the
                              Centers for Disease Control by conducting epidemiological tracebacks
                              for salmonella enteritidis and related activities. In addition, APHIS occa-
                              sionally assists in investigating for chemical residues in food animals
                              when states or other federal agencies request it. Also, APHIS has assisted
                              FDA in the area of plant health by monitoring plant-food import commod-
                              ities for chemical residues.

_____
   ---.-_~-
Critical Food Safety and      APIIIS provided the following list of items it believes will be critical food
Quality Issues of the 1990s   safety and quality issues of the 1990s:

                          l Microbiological foodborne contamination, especially in populations at
                            risk such as fetuses, the elderly, and immunosuppressed persons,
                            including AIDS patients and chemotherapy patients.
                          . Public perceptions of food safety, including improving the communica-
                            tion of risks to the public and media, responding to publicized food
                            safety concerns of consumer groups and others, and dealing with poten-
                            tial effects of consumer perceptions of food safety on the economic
                            health of the agricultural industry.


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                               l   Tools for food safety policy-making in government agencies, including
                                   increasing federal emphasis on risk assessment and risk management,
                                   focusing on the food safety process rather than the safety of food prod-
                                   ucts, developing microbiological criteria, and stressing the importance of
                                   uniform national standards for food safety tolerance levels.
                               l   Tools for improved implementation of food safety policies, such as
                                   developing more rapid, reliable tests to monitor microbiological and
                                   chemical contaminants.
                               l   Ante- and post-mortem food inspection activities for additional species
                                   of animals (e.g., rabbits and fish), such as those performed by FSIS for
                                   cattle, swine, sheep, goats, and poultry.


                                   ATF is responsible for administering and enforcing laws relating to fire-
Bureau of Alcohol,                 arms and explosives, as well as those covering the production, use, and
Tobacco   and   Firearms           distribution of alcohol and tobacco products.


Major Legislation                  ATF stated that the two primary laws it administers and enforces
                                   relating to alcoholic beverages are the Federal Alcohol Administration
                                   Act (27 U.S.C. 201, et seq.) and the Internal Revenue Code relating to
                                   distilled spirits, wines, and beer.

                                   The Federal Alcohol Administration Act

                           l gives ATF authority to issue regulations regarding the labeling and
                             advertising of alcoholic beverages to ensure that they provide the con-
                             sumer with adequate information concerning product identity and
                             quality;
                           l authorizes ATF to issue permits to allow firms to engage in the produc-
                             tion, importation, or wholesale distribution of alcoholic beverages;
                           l gives ATF the authority to revoke or suspend a permit for willful viola-
                             tion of regulations issued under the act; and
                           . prohibits selling or shipping in interstate or foreign commerce distilled
                             spirits, wines, or malt beverages in bottles, unless such products are bot-
                             tled, packaged, and labeled in conformity with regulations prescribed by
                             the Secretary of the Treasury.

                                   The Internal Revenue Code gives ATF authority to detain any container
                                   that is in violation of the law (26 U.S.C. 5311) and also gives ATF seizure
                                   and forfeiture authority (26 USC. 7302).




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                         These two laws provide a comprehensive system of control over the pro-
                         duction and distribution of alcoholic beverages, including on-site inspec-
                         tions, and procedures that require the advance approval of statements
                         of processes, of formulas showing each ingredient to be used in the
                         product, and all labels.

                         ATF stated that it has very limited statutory responsibility relating to the
                         safety of alcoholic beverages. It said that the laws it administers do not
                         address the safety of alcoholic beverages and do not give ATF any spe-
                         cific responsibilities in this area. However, ATF added that, for about the
                         past 50 years, ATF and its predecessor agencies have exercised consider-
                         able control over the safety of alcoholic beverages through these and
                         other federal laws and through agreements with other federal agencies.
                         In addition, the Alcoholic Beverage Labeling Act of 1988 (27 U.S.C. 213
                         et seq.) requires a health warning statement on the labels of all alcoholic
                         beverages bottled after November 17,1989.


Organization and         ATF headquarters is located in Washington, D.C., but most of its per-
Responsibilities         sonnel are stationed throughout the United States, where many of its
                         operational functions are performed.

                         ATF has no operational segments exclusively devoted to the safety of
                         alcoholic beverages. In fiscal year 1989, safety activities were con-
                         ducted, in addition to all other field enforcement activities, by approxi-
                         mately 430 inspectors in 39 area offices and 5 regional offices.

                         ATF'S Industry Compliance Division is responsible for oversight of activi-
                         ties relating to laboratory analysis of alcoholic beverages, identification
                         of adulterants in alcoholic beverages, recall notices, and the conduct of
                         recalls. ATF operates two alcohol laboratories located in Rockville, Mary-
                         land, and in Walnut Creek, California.


Program Activities       Regarding food safety, ATF'S policy is that the American consumer
                         should be protected from hazards associated with exposure to contami-
                         nated or mislabeled alcoholic beverages. ATF informed us that its major
                         activities include

                     l   establishing standards of identity, including regulations that prescribe
                         ingredients, alcoholic strength, formula requirements, and manufac-
                         turing processes for most wines and distilled spirits;



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                          . approving formulas for alcoholic beverages prior to their production or
                            importation, which permits ATF to examine the formula and product for
                            the presence of injurious or prohibited ingredients;
                          . sampling alcoholic beverages at production, wholesale, and retail levels
                            to ensure product integrity and to examine for the presence of injurious
                            or prohibited ingredients;
                          . requesting voluntary recalls of alcoholic beverages that are improperly
                            labeled, that contain ingredients not approved for food use, that contain
                            ingredients in excess of regulatory limitations, or that are not produced
                            in accordance with approved formulas; and
                          . enforcing the Alcoholic Beverage Labeling Act of 1988.

                              Enforcement Activities

                              ATF has notified permit holders that it will consider suspending or
                              revoking permits of persons who knowingly sell mislabeled alcoholic
                              beverages, i.e., beverages that are not in conformity with standards of
                              identity, not in conformity with formula, or containing prohibited
                              ingredients.

                              ATF  can use detention to prevent the sale or removal of an adulterated or
                              mislabeled alcoholic beverage until permanent disposition is arranged or
                              until a problem such as mislabeling is corrected.


Coordination With Other       ATF coordinates its alcohol activities with FDA and the United States Cus-
Federal Agencies              toms Service.

                              Fm has responsibility for the safety of alcoholic beverages under FFDCA.
                              However, because of ATF'S long regulatory experience with the alcoholic
                              beverage industry, ATF and FDA signed a memorandum of understanding
                              in November 1987 which clarifies and delineates the enforcement
                              responsibilities of each agency relating to the identification, testing, and
                              recall of alcoholic beverages considered adulterated under FFJXA.

                              Under the agreement, ATF became the primary federal agency respon-
                              sible for the safety of alcoholic beverages. The following are some provi-
                              sions of the agreement:

                          l   ATF will, in consultation with FDA, initiate rulemaking to require the label
                              disclosure of ingredients identified by FDA as posing a potential health
                              risk.



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                      .   ATF will test alcoholic beverages to determine the extent of adulteration
                          problems.
                      9 ATF will have primary responsibility for requesting firms to conduct vol-
                        untary recalls of alcoholic beverages found to be adulterated under
                        FFDCA, after consulting with FDA, and for monitoring recalls.
                      . ATF will develop guidelines for identifying adulterated alcoholic bever-
                        ages and for implementing voluntary product recalls.
                      l FDA will provide ATF, upon request, with a health hazard evaluation with
                        respect to any substance found in alcoholic beverages.
                      l FDA will contact ATF when it learns or is advised that an alcoholic bev-
                        erage is or may be adulterated.
                      . FDA and ATF laboratories will exchange information concerning method-
                        ologies and techniques for testing alcoholic beverages.

                          ATF coordinates with the United States Customs Service to prevent the
                          entry of adulterated alcoholic beverages by identifying locations where
                          contaminated alcoholic beverages are likely to enter the United States.
                          ATF also may request Customs’ assistance in determining whether it is
                          necessary to detain contaminated products, to require proof that the
                          products are not contaminated before entry, or to take other appro-
                          priate action.


                          The Centers for Disease Control is charged with protecting the nation’s
Centers for Disease       public health by providing leadership and direction in preventing and
Control                   controlling diseases and other preventable conditions and responding to
                          public health emergencies.


Major Legislation         The Public Health Service Act, as amended (42 U.S.C. 201 et seq.), pro-
                          vides general authority for the Public Health Service to engage in
                          research and investigations. Pursuant to this authority, CDCengages in
                          public health activities related to food safety and quality.


Organization and          Headquartered in Atlanta, Georgia, CDC has nine field offices outside of
Responsibilities          Georgia. CDC is responsible for researching, monitoring, and controlling
                          outbreaks of foodborne diseases.




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Program Activities            WC’S role relating to foodborne disease is to

                          l   monitor, identify, and investigate foodborne disease problems to deter-
                              mine the contributing factors;
                          l   work with FDA, USDA, the National Marine Fisheries Service, states, uni-
                              versities, and industry to develop control methods; and
                          l   evaluate the effect of the control methods.


Funding and Staffing          For fiscal year 1989, CDC used about $2.6 million for public health activi-
Levels                        ties related to food safety and quality. During the year, staffing related
                              to food safety and quality consisted of about 25 full-time equivalent
                              staff years.


Coordination With Other       CDCcoordinates its foodborne disease activities with FDA, USDA, and the
Federal Agencies              National Marine Fisheries Service.



Critical Food Safety and      CDC stated that despite progress in improving the quality of food and
Quality Issues of the 1990s   food handling in the United States, foodborne disease remains one of the
                              most common and most important causes of illness and deaths in the
                              United States. CDCestimates that about 6 million cases of illness and
                              9,000 deaths relating to foodborne disease occur each year.

                              CDCpointed out that there is increasing recognition that many illnesses
                              with no apparent mode of transmission (and thus not reported as a food-
                              borne illness) are actually foodborne. Also, CDC stated that new food-
                              borne pathogens are being discovered, new food vehicles of transmission
                              have emerged as important causes of disease, previously little-noticed
                              pathogens are proving to cause foodborne disease, and antimicrobial
                              resistance of some foodborne pathogens is increasing.

                              CDC also stated that the food industry is large, complex, and changing
                              rapidly in the following ways:

                          l Greater interstate and international movement of animals spreads
                            pathogens.
                          . Trends in animal husbandry facilitate the spread of disease between ani-
                            mals and encourage the use of prophylactic and therapeutic antibiotics,
                            thereby increasing the antimicrobial resistance of foodborne pathogens.




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