Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
FDA Oversight of State 
Food Firm Inspections 
A Call for Greater Accountability 
JUNE GIBBS BROWN 
Inspector General 
JUNE 2000 
OEI-01-98-00400  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 
protect the integrity of the Department of Health and Human Services programs as well as the 
health and welfare of beneficiaries served by them.  This statutory mission is carried out through a 
nationwide program of audits, investigations, inspections, sanctions, and fraud alerts.  The 
Inspector General informs the Secretary of program and management problems and recommends 
legislative, regulatory, and operational approaches to correct them. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 
Inspector General.  It conducts short-term management and program evaluations (called 
inspections) that focus on issues of concern to the Department, the Congress, and the public.  The 
inspection reports provide findings and recommendations on the efficiency, vulnerability, and 
effectiveness of departmental programs. 
OEI's Boston Regional Office prepared this report under the direction of Mark R. Yessian, Ph.D., 
Regional Inspector General.  Joyce M. Greenleaf, M.B.A., Assistant Regional Inspector General, 
also contributed to this report.  Principal OEI staff included: 
BOSTON  HEADQUARTERS 
Elizabeth A. Robboy, Lead Analyst  Elise Stein, Director, Discretionary Programs Staff 
Nicola Y. Pinson, Lead Analyst 
To obtain copies of this report, please call the Boston Regional Office at (617) 565-1050. 
Reports are also available on the World Wide Web at our home page address: 
http://www.dhhs.gov/progorg/oei  E X E C U T I V E   S U M M A R Y  
PURPOSE 
To assess the Food and Drug Administrations oversight of food firm inspections 
conducted by States through contracts and partnership agreements. 
BACKGROUND 
Inspections as a Key to Food Safety 
The World Health Organization recently estimated that up to 30 percent of people living 
in industrialized countries may suffer from foodborne illnesses each year.  In the United 
States, the Centers for Disease Control and Prevention recently estimated that foodborne 
diseases cause about 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each 
year.  The annual cost of foodborne illness in the United States is estimated to be between 
$7.7 and $23 billion. 
The Food and Drug Administration (FDA) plays a key role in overseeing the nations food 
supply.  It is responsible for the oversight of most foods involved in interstate commerce, 
with the major exceptions of meat and poultry.  Under the Federal Food, Drug, and 
Cosmetic Act, the FDAs primary role in food safety is to inspect the conditions under 
which food is manufactured, processed, packed, and stored.  The States also play a critical 
role in overseeing the nations food supply.  State and local governments conduct the 
majority of inspections in the U.S., including food retailers, manufacturers, processors and 
distributors within their State boundaries in accordance with their own laws and 
authorities. 
Over the past 25 years, FDA has extended its inspection coverage by utilizing the 
resources and expertise in the States to fulfill its responsibility.  For many years, FDA 
relied on contract arrangements, through which FDA paid the States to conduct 
inspections in accord with Federal regulations.  In recent years, FDA has initiated 
partnership agreements with a number of States.  Under these arrangements, the States 
agree to conduct inspections under their own authorities, without Federal funding, and to 
share the results with FDA.  An effective food safety system depends on the collective 
efforts and coordination among Federal, State and local levels of government. 
FDA Oversight as a Key to Accountability 
In recent years, groups including the National Academy of Sciences, the Association of 
Food and Drug Officials, industry trade associations, consumer groups, and the States 
1 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  themselves have recognized the importance of strong Federal oversight of State food firm 
inspections.  Such oversight is essential to assure consumers that necessary food safety 
protections are in place, and to assure domestic industries and international trading 
partners that the FDA is committed to the quality and uniformity of food safety regulation. 
This Inquiry 
In this report, we begin by reviewing three fundamental factors that underscore the 
importance of FDA oversight of State inspections conducted through contracts and 
partnership agreements.  We then turn, in more depth, to assess the adequacy of that 
oversight system.  We draw on a variety of sources in this inquiry, including analysis of 
FDA inspection data, national surveys, site visits, observations of FDA audits, reviews of 
the State contracts and partnership agreements, reviews of year-end evaluations, and 
interviews with industry, consumer groups, and food policy experts. 
IMPORTANCE OF OVERSIGHT 
FDA Relies Heavily on State Food Firm Inspections. 
We found that in the past 3 years, States conducted through contracts and partnership 
agreements, on average each year, 61 percent of food firm inspections recorded in FDAs 
national database.  Although traditionally States have focused heavily on low-risk food 
firms, increasingly, these State inspections are focused on high-risk food firms. 
Partnership agreements, which rely primarily on State authorities and resources, are 
becoming a significant source of food firm inspections.  State inspections offer FDA an 
important source of industry coverage, as well as expertise. 
States Vary Significantly in their Capacities to Conduct Inspections. 
We identified five significant ways in which State inspections and food programs vary: 
inspection classifications, enforcement authorities, inspection authorities and regulations, 
inspector education and training, and time spent on inspections.  These variations raise 
concern about the quality and uniformity with which FDAs food program is carried out. 
Variation in State Regulatory Programs can Inhibit Commerce. 
The variation in State laws and inspection practices adds complications, costs, and 
frustrations for food firms engaged in multi-State commerce.  For our international trading 
partners, variation in State laws and inspection practices can undermine confidence in the 
uniformity of U.S. food safety standards and enforcement efforts. 
2 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FINDINGS 
FDAs Oversight of State Food Firm Inspections is Limited. 
Under contracts, FDA obtains minimal information to assess the quality of State 
food firm inspections. 
FDAs on-site audits have declined.  Over the past 5 years, the number of audits 
dropped 59 percent, from 253 in 1993 to 104 in 1998.  In 1998, FDA district 
offices did not conduct a single audit in 21 of the 38 States holding contracts. 
FDAs on-site audits provide a limited basis for assessing State performance. 
FDA relies primarily on independent audits, which focus on the accuracy of 
inspection findings but give little attention to how State inspectors drew 
conclusions.  FDAs lack of documentation of State performance further limits the 
effectiveness of audits. 
FDAs reviews of State contract inspection reports lack much rigor.  FDA 
conducts minimal assessment of the quality of inspection reports submitted by 
States.  In response to our survey, 14 of 17 FDA district offices overseeing 
contracts reported that they use no formal criteria to evaluate the quality of the 
reports. 
FDA rarely seeks input from external sources to evaluate State performance. 
FDA takes little advantage of its public meetings, food safety hotlines, or food 
safety websites to solicit input from food firms, trade associations, or consumers 
about the quality of State inspections. 
Under partnership agreements, FDA obtains even less information to assess the 
quality of State food firm inspections. 
FDA does not audit State performance, but participates in some joint 
inspections with States.  FDA and State officials regard joint inspections as a 
mechanism to provide on-site training for both Federal and State inspectors rather 
than as a tool to evaluate State performance. 
FDAs reviews of State partnership inspection reports are even more limited 
than its reviews of contract inspection reports.  States submit differing levels of 
information about partnership inspections, depending on the States inspection 
resources, policies, and procedures.  We found that FDA district offices often 
lacked enough information to assess the quality of inspections. 
FDA provides limited feedback to States on the quality of their inspections. 
3 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  The majority of FDAs ongoing feedback to States relies on informal 
communication and individual district office initiatives.  FDA does not 
routinely provide States with written feedback on either its on-site audits or 
reviews of State inspection reports. 
FDAs performance evaluations provide States with little feedback about the 
quality of State inspections.  The majority of contract and partnership 
evaluations contain cursory and general comments with little meaningful 
assessment of States performance.  Furthermore, FDA rarely provides the 
evaluations to States. 
FDAs feedback places little emphasis on improving the quality of State 
inspections.  FDAs feedback is geared toward identifying deficiencies in food 
firm inspections rather than enhancing State performance.  FDA does little to 
identify best practices among States and disseminate this information. 
FDA provides limited feedback to the public regarding its oversight of contracts and 
partnership agreements. 
FDA does not make information available about its reliance on State 
inspections or about State performance.  Despite its extensive reliance on State 
inspections, it shares little information about the extent and nature of its reliance. 
Such information would provide an important source of FDA accountability to 
consumer, industry, and other groups. 
FDA Faces Significant Barriers in Overseeing States 
FDAs ability to conduct quality oversight depends largely on its own internal capacities. 
A number of barriers inhibit FDAs capacity to conduct effective oversight: 
Low priority of food safety inspections.  Without a statutory requirement to inspect a 
minimum number of food firms, FDAs resources to conduct food firm inspections has 
diminished.  Within the food inspection program, FDAs resources to oversee State food 
firm inspections competes with its own resources to inspect food firms. 
Limited leverage to oversee partnership agreements.  The majority of FDA and State 
officials we spoke with underscored the fact that States are doing FDA a favor by helping 
the FDA to extend its inspection coverage at a very low cost.  FDAs heavy reliance on 
States compromises its ability to be truly critical of these inspections. 
Reduced training and agency expertise.  Maintaining agency expertise is vital to 
effectively overseeing States.  In the past decade, however, formal training has declined 
and FDA has lost field experience in States that inspect the bulk of the food firms. 
4 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Limited accountability of FDA district offices.  FDA does little to assess the 
effectiveness of district offices in overseeing State inspections. 
Lack of important enforcement authorities.  FDA must rely on State enforcement 
authorities that it lacks, including the ability to revoke a firms license, to immediately 
embargo food suspected of being adulterated, and to access all of a food firms records 
without a Federal warrant.  Several FDA and State officials have raised concerns that this 
reliance compromises FDAs ability to be critical of State inspections. 
RECOMMENDATIONS 
State governments play a critical role in ensuring the safety of the nations food supply, 
both under their own authorities and in concert with FDA through contracts and 
partnership agreements.  They provide valuable resources and expertise that serve as a 
complement to FDAs own inspection efforts.  Our recommendations recognize and build 
on the importance of this State role. 
For State inspections carried out under FDA auspices, it is essential that FDA provide 
effective oversight to ensure both the quality and uniformity of inspections.  FDA brings 
important strengths to this oversight role through a tradition that emphasizes science-
based research and a public health perspective.  We offer seven recommendations, based 
on the following template, on how FDA can provide leadership to address the 
shortcomings we identified in its current system of oversight.  FDA has already 
undertaken some recent initiatives in the direction we call for. 
Template For Effective FDA Oversight 
of State Food Firm Inspections 
U Equivalency: Equivalency among Federal and State food safety 
standards, inspection programs, and enforcement practices. 
U On-site Audits: An effective on-site mechanism for evaluating State 
inspection performance. 
U Inspection Information: Routine submission of standardized 
inspection information. 
U External Sources: Information from varied external sources on State 
inspection performance. 
U Feedback to States: Substantive and timely FDA feedback to States 
on inspection performance. 
U Internal Capacities: Enhanced FDA capacities to conduct effective 
oversight. 
U Public Information: Proactive public disclosure of FDAs reliance 
upon and oversight of State inspections. 
5 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  We present our specific recommendations below.  But first we offer a caution. 
An Initial Caution:  FDA Should Reevaluate Its Reliance on the Partnership 
Agreements as a Mechanism for Conducting Inspections. 
Partnership inspections have grown to account for 43 percent of the State food firm 
inspections conducted in association with FDA.  While many of the State inspections may 
well be of high quality, FDA is not in a position to adequately attest to the quality or 
uniformity of these inspections. 
We believe that a two-tier system of FDA oversight, under which there is less oversight of 
partnerships than contracts, is inappropriate.  As follows, we offer our recommendations 
as actions that FDA can take to oversee State inspections conducted through both the 
partnership agreements and contracts.  FDA must be able to assure consumers, industry, 
and international trading partners that its commitment to quality and uniformity is 
independent of the mechanism through which inspections are conducted. 
Recommendation 1.  FDA Should Work with States to Achieve Basic Equivalency 
in Food Safety Standards and Laws, and in Inspection Programs and Practices. 
< Pilot test a system audit as a mechanism to foster equivalency and evaluate State 
capacity and performance. 
Recommendation 2.  FDA Should Devote High Priority to Improving its On-Site 
Audit Mechanism for Evaluating the Effectiveness of State Inspections. 
< Stress joint audits rather than independent audits. 
< Develop guidance for effective on-site audits. 
< Determine the appropriate minimum frequency for on-site audits. 
Recommendation 3.  FDA Should Require that States Routinely Provide FDA with 
Standardized Information on the Inspections They Conduct. 
< Define a core set of information to collect from States about food inspections. 
< Provide guidance on the extent and nature of inspection report reviews. 
Recommendation 4.  FDA Should Draw on Multiple External Sources of 
Information in Assessing State Inspection Performance. 
< Solicit feedback from industry, consumer, and other groups on the adequacy of State 
inspections. 
Recommendation 5.  FDA Should Provide Substantive and Timely Feedback to 
States on Their Inspection Performance. 
< Provide States with ongoing and written feedback from on-site audits. 
< Provide States with periodic evaluations assessing overall performance. 
< Promote information exchange on promising approaches of State programs. 
6 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Recommendation 6.  FDA Should Enhance Its Internal Capacities to Conduct 
Effective Oversight. 
< Ensure inspector competence in both inspection and audit functions. 
< Hold district offices more accountable for conducting effective oversight. 
< Ensure the systematic identification of all food firms in interstate commerce. 
< Seek broader FDA enforcement authorities. 
Recommendation 7.  FDA Should Increase Public Disclosure of Its Oversight of 
State Food Firm Inspections. 
< Make more explicit information available about FDAs reliance upon States and its 
oversight of State inspections. 
COMMENTS ON THE DRAFT REPORT 
We received written comments on the draft report from the Food and Drug 
Administration, the Association of Food and Drug Officials, the National Food Processors 
Association, the National Fisheries Institute, and the Center for Science in the Public 
Interest.  In general, the report received wide support among each of the groups.  In the 
body of the report, we summarize the major comments and offer our responses.  We 
incorporated several changes recommended by these groups in the text of the final report. 
The full text of each set of comments is included in appendix M. 
The Food and Drug Administration 
The FDA welcomes our report as a tool to strengthen Federal oversight of State food 
safety inspections.  The FDA agrees with the majority of our recommendations and points 
to a number of recent initiatives underway that move in the direction we call for.  The 
FDA does not agree with our recommendation to solicit external information sources in 
assessing State performance.  The agency believes that its own audit process is the best 
way to assess State performance.  The agency also does not address our specific 
recommendations about increasing public disclosure of information regarding FDA 
oversight and State performance.  Regarding oversight of the partnership agreements, the 
FDA agrees that it must fundamentally modify the nature of these agreements. 
We recognize that FDA is dealing constructively with many of the shortcomings we 
identify in our report.  We encourage the agency to continue to do so.  We also urge the 
agency to reconsider the value of external sources of information in assessing State 
performance.  We continue to believe that such information can serve as an important 
complement to FDAs own audit information.  On the matter of publicly disclosing 
information, we urge FDA to take immediate action to post the performance information 
we recommend.  Such information could include identification of the States with which 
FDA holds a contract or partnership, the number and types of inspections under each 
arrangement, the ratio of FDA-to-State inspections in particular States, and the FDAs 
assessments of State performance through audits or periodic performance evaluations. 
7 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  External Organizations Comments 
The external parties express support for the major thrust of our findings and 
recommendations.  Each group also raises several concerns.  The Association of Food and 
Drug Officials (AFDO) emphasizes the expertise of many State programs and questions 
whether all FDA district offices are currently in a position to adequately judge the quality 
and uniformity of State inspections.  The AFDO also underscores the work of the Roles 
and Responsibilities work group within the National Food Safety System (NFSS) project 
as an important reference point that FDA may want to consider in redesigning its 
oversight of State food firm inspections. 
The two industry groups, the National Food Processors Association (NFPA), and the 
National Fisheries Institute (NFI), express particular support for our recommendation to 
incorporate feedback from external parties in the evaluation of State programs.  The 
NFPA urges that our recommendations go further by also including feedback from 
external parties on the performance of Federal inspections.  Neither group agrees with our 
recommendation to provide FDA with additional enforcement authorities.  The groups 
believe that the current system of relying on State authorities for enforcement has worked 
well.  The Center for Science in the Public Interest (CSPI) strongly supports our report, 
but does not feel that we went far enough with our recommendations.  The CSPIs 
comments point out vulnerabilities and potential weaknesses in State inspection programs, 
such as the potential influence of State politics and economics on regulatory oversight. 
The group suggests that FDA should restrict reliance on States to low-risk inspections. 
We are pleased with the broad support from each of the external parties for the major 
thrust of the findings and recommendations in our report.  On the matter of State and 
Federal expertise, we believe that AFDO raises an important point regarding the 
variation in food safety expertise and inspection and audit practices among FDA district 
offices.  We recommend that FDA ensure inspector competence in both inspection and 
audit functions.  Such expertise is critical to the credibility of the oversight process.  We 
also recognize the current work underway through the NFSS project and we have 
modified the text of our report to more fully reflect this work.  Regarding concerns with 
our recommendation to provide FDA with additional enforcement authorities, we 
continue to believe that these authorities are a vital component of effective oversight. 
We, along with other groups, raise concern that FDAs reliance on States to take 
enforcement actions may compromise FDAs ability to be critical of States performance. 
On the issue of Federal reliance on State inspections, we do not seek to determine what 
would be an appropriate balance of inspection duties among Federal and State 
governments.  However, we do emphasize that FDA should assure consumers that its 
commitment to food safety is no less under partnerships than it is under contracts. 
8 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  T A B L E  O F  C O N T E N T S  
EXECUTIVE SUMMARY  PAGE 
INTRODUCTION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10

IMPORTANCE OF OVERSIGHT 
FDA Oversight is Vital 
Heavy reliance on States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  15

Variation among States  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Uneven regulatory playing field  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

FINDINGS 
FDA Oversight is Limited 
Minimal information under contracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Less information under partnerships  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Limited feedback to States  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Limited feedback to the public  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

FDA Faces Significant Barriers to Conduct Oversight 
Low priority of food safety oversight  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Limited leverage to oversee partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Reduced training and agency expertise  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Limited accountability of FDA district offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Lack of important enforcement authorities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

RECOMMENDATIONS  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  31

COMMENTS ON THE DRAFT REPORT  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  43

APPENDICES 
A: States holding contracts and partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  48

B: Types of partnership agreements  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

C: FDA district offices overseeing contracts and partnerships . . . . . . . . . . . . . . . . . . . .  51

D: Study methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

E: FDA and State inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

F: State contract inspection data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  55

G: FDA and State enforcement authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

H: State educational and training requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . .  58

I: FDA contract audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

J: Partnership agreement document analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

K: Contract semi-annual performance evaluation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

L: Partnership annual performance evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  65

M: Full text of comments on the draft report  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

N: Endnotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

9 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  I N T R O D U C T I O N  
PURPOSE 
To assess the Food and Drug Administrations oversight of food firm inspections 
conducted by States through contracts and partnership agreements. 
BACKGROUND 
Importance of Food Safety 
The World Health Organization recently estimated that up to 30 percent of people in 
industrialized countries may suffer from foodborne illness each year, and the problem is 
likely to be greater in developing countries.1  In the United States each year, the Centers 
for Disease Control and Prevention estimated that foodborne diseases cause about 76 
million illnesses, 325,000 hospitalizations, and 5,000 deaths.2  Even these figures may be 
low due to the number of foodborne illnesses that go unreported each year.  The 
symptoms of foodborne illness range from mild stomachaches and intestinal upset to life-
threatening nerve, liver, and kidney problems.  The annual cost of foodborne illness in the 
United States each year is estimated to be between $7.7 and $23 billion.3  Some experts 
project that the reported incidence of foodborne illness will increase by 10 to 15 percent in 
the next decade.4 
In 1997, in response to increasing challenges in maintaining the safety of the nations food 
supply, the President launched the Food Safety Initiative to improve food safety and 
reduce the incidence of foodborne illness.  At the request of Congress, the National 
Academy of Sciences assessed the effectiveness of the current food safety system.  The 
Academys report, entitled, Ensuring Safe Food from Production to Consumption, raised 
concerns about the fragmentation of the current system.5  In 1998, the President 
established a Council on Food Safety to coordinate food safety policy and resources. 
Each of these groups has recognized the roles for Federal, State and Local agencies and 
the importance of Federal oversight in ensuring the safety of our national food supply. 
Inspections as a Key to Food Safety 
Inspections of food firms, carried out by State and Federal agencies, are an essential 
component of the national food safety system intended to prevent foodborne illnesses. 
The 1997 report to the President entitled, Food Safety from Farm to Table: A National 
Food Safety Initiative, cited food inspections as one of six key components of a national 
food safety system.6 
10 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  The Food and Drug Administration (FDA) plays a key role in overseeing the nations food 
supply.  It is responsible for the oversight of most foods involved in interstate commerce, 
with the major exceptions of meat and poultry.  Under the Federal Food, Drug, and 
Cosmetic Act, the FDAs primary role in food safety is to inspect the conditions under 
which food is manufactured, processed, packed, and stored.  FDAs 20 district offices 
carry out the food inspections under guidance from FDA headquarters. 
The States also play a critical role in overseeing the nations food supply.  State and local 
governments conduct the majority of inspections in the U.S., including food retailers, 
manufacturers, processors and distributors within their State boundaries in accordance 
with their own laws and authorities.  Many of the food firms inspected by States may also 
fall under Federal jurisdiction if they are involved in interstate commerce.  States are 
generally in the field more frequently than FDA and offer an important source of front-line 
experience and expertise. 
FDA Contracts and Partnership Agreements with States 
Over the past 25 years, FDA has extended its inspection coverage by utilizing the 
resources and expertise in the States to fulfill its responsibility.  Until recently, this 
assistance was limited to contract arrangements, through which FDA paid the States to 
conduct inspections in accordance with Federal regulations.  In 1998, FDA held 40 food 
contracts with 38 States (see appendix A).7  These contracts covered 4,155 food firm 
inspections, ranging from 10 to 353 per contract.  In States where FDA did not enter into 
a contract, FDA conducted the food firm inspections itself.  In 1998, FDA spent $2.04 
million on the State food contracts. 
Since 1994, FDA has further extended its inspection coverage through partnership 
agreements with States.  Many, though not all of these States, also hold contracts with 
FDA.  Under partnership agreements, States agree to conduct inspections under their own 
authorities, without Federal funding, and to share the results with FDA.  In 1998, FDA 
held 37 such partnership agreements with 29 States (see appendix B).  These agreements 
covered 3,165 food firm inspections, ranging from as few as 5 to as many as 635 food firm 
inspections per partnership agreement.  In 1998, FDA contributed $319,000 to the 
partnership agreements in the form of training, technical assistance, and equipment. 
The 20 FDA district offices negotiate with the States for the types of food firm inspections 
to be conducted under the contracts and partnership agreements.  These inspections may 
be of high- or low-risk food firms.  Currently, the FDA has no standardized, agency-wide 
criteria for measuring the risk of a food firm.8  In general, high-risk food firms involve 
food products or manufacturing and processing technologies that have higher potential for 
contamination.  Seafood firms and low-acid canned food firms are two major categories of 
high-risk food risk food firms inspected by States through contracts and partnership 
agreements.  Food firms typically considered to be low-risk include warehouses, bottlers, 
and bakeries. 
11 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FDA has set forth specific mechanisms for its 20 district offices to oversee the State 
contracts and partnership agreements.9  In 1998, 17 of these offices were responsible for 
overseeing State food inspection contracts; and 17 offices were responsible for overseeing 
State partnership agreements related to food inspections (see appendix C).  The oversight 
mechanisms and the basics of the two arrangements are more fully described in the primer 
on page 12. 
FDA Oversight as a Key to Accountability 
Oversight of State food firm inspections conducted in association with FDA is essential to 
assure consumers that necessary food safety protections are in place, and to assure 
domestic industries and international trading partners that FDA is committed to achieving 
quality and uniformity in food safety regulation.  In recent years, a number of other groups 
have recognized the importance of strong Federal oversight including the Presidents 
Council on Food Safety, the National Academy of Sciences, industry trade associations, 
consumer groups, and the States.  For example, in January 2000, the Association of Food 
and Drug Officials issued a statement to FDA underlining, from a general State 
perspective, the importance of Federal oversight to assure to U.S. consumers and our 
foreign trading partners that the inspections conducted by States are indeed equivalent to 
those conducted by the federal government. 
Two Recent Initiatives in Food Safety 
The Hazard Analysis Critical Control Point (HACCP) Approach to Inspections.  The 
HACCP system, which introduces a science-based system of control and prevention, has 
fundamentally altered the way in which government oversees and inspects the nations 
food supply. A HACCP inspection focuses on a science-based assessment of a food firms 
hazard and prevention control processes.  This is a dramatic shift from the traditional 
approach of assessing food safety through basic observations of sanitation.10  In 1997, 
FDA implemented final regulations requiring the seafood industry to implement HACCP 
programs and is currently sponsoring pilot HACCP programs in other products and 
industries. 
In 1999, FDA set forth a goal of inspecting 100 percent of the seafood industry for 
compliance with the seafood HACCP requirements.  Many FDA district offices have been 
struggling to fulfill this requirement given their rising workloads.  Increasingly, they are 
relying on States to meet the seafood HACCP inspection requirements.  Oversight takes 
on an increasing significance given the potential risks involved with seafood and the 
complexity of these inspections. 
The Emergence of a Nationally Integrated Food Safety System.  Concerns about our 
fragmented system of food oversight have led a number of groups, including the 
Presidents Council on Food Safety, the Association for Food and Drug Officials, and the 
National Academy of Sciences, to promote a nationally integrated food safety system that 
12 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  maximizes and coordinates food safety resources.  Such a system would integrate food 
safety activities at the local, State, and Federal levels of government.  While different 
models are being discussed, many envision a system in which the Federal government 
would provide leadership through standard setting, technical support, risk assessment, 
training, and program oversight and evaluation.  While the Federal agencies would not 
turn over the entire inspection process, the States and local governments would be 
responsible for conducting the great majority of food inspections.  Such an integrated 
regulatory system holds much promise. 
In an effort known as the National Food Safety System (NFSS) project, Federal, State and 
local officials have initiated six work groups to address issues pertaining to the goal of a 
seamless federal-state-local food safety system.11  In particular, these work groups are 
addressing issues relevant to Federal oversight of State inspections.  Federal and State 
officials have called for a framework that includes equivalent minimum regulatory 
standards; adequate training of inspectors; information exchange on inspection results; 
verification of performance; and enforcement.12 
This Inquiry and Report 
This study focuses on FDA oversight of State inspections conducted under State food 
contracts and partnerships agreements.13  These inspections focus on food manufacturing 
and processing firms.  Throughout the report, we refer to these inspections as food firm 
inspections.14  We do not address State contracts related to medicated feed, tissue residue, 
and feed contaminants.  We also exclude from our analysis other food inspection 
programs, such as Cooperative Programs pertaining to Milk, Shellfish, and Retail Foods.15 
In this study, we did not assess inspections that States are conducting independently of 
FDA, nor did we seek to assess the quality of State inspections. 
Our inquiry draws on a variety of sources.  These include: an analysis of FDAs national 
inspection data; an analysis of FDAs audit data; a review of all 40 State food contracts 
and a review of 19 of the 37 partnership agreements involving food inspections; a review 
of the year-end performance evaluations of States; a review of FDAs oversight guidance 
documents; a survey of the 20 FDA district offices, for which we had a 100 percent 
response rate; a survey of the 40 State food inspection agencies holding contracts, for 
which we had a 92 percent response rate; in-depth site visits to 3 FDA district offices and 
3 States; observations of FDA joint and independent audits; and interviews with industry, 
consumer groups, and food policy experts.  See appendix D for a fuller description of the 
methodology. 
We conducted this inspection in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
13 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FDA Oversight of State Food Firm Inspections: A Primer 
1. 	 Three Types of Food Firm Inspections: 
FDA and State food firm inspections fall into one of 
three categories. This report focuses on inspections in the middle category. 
State Inspections  State Inspections  FDA Inspections 
in Association with FDA 
The States oversee all food  There are two types of arrangements  FDA oversees all food 
firms operating within their  through which States may conduct  firms involved in 
State boundaries, regardless  inspections in association with FDA:  interstate commerce. FDA 
of whether the firms are also  district offices conduct 
subject to FDA oversight.  Contracts: FDA pays the States to  these inspections in accord 
The States conduct these  conduct these inspections. They are  with Federal inspection 
inspections under their own  conducted by the States under the  laws and procedures. The 
authorities and procedures.  auspices of Federal food inspection  great majority of the food 
laws and procedures.  firms in this category are 
also inspected by States, 
Partnership Agreements: FDA does  under State authorities. 
not pay the States to conduct these 
inspections, although it may provide 
training and equipment to the States. 
These are essentially State 
inspections, for which the States 
share information with FDA. The 
States conduct these inspections 
under their own authorities and 
procedures. 
2. FDA Oversight of the Contracts: 
Audits: FDA conducts audits of State inspections. These can take the form of independent audits that occur within 
30 days of a State inspection, or joint audits that are conducted concurrently with the State. FDA audit standards 
call for district offices to conduct a level of audits proportionate to the number of inspections under each contract. 
Contract Inspection Reports: FDA reviews contract inspection reports. States submit these reports to FDA within 
15 days of completion of an inspection. They are standardized forms, designed in accordance with Federal food 
inspection laws. 
Semi-Annual Evaluations: FDA evaluates State performance twice a year. These evaluations are designed to 
summarize audits conducted, deficiencies found in food firms, and provide an assessment of State performance. 
3. FDA Oversight of the Partnership Agreements: 
Joint Inspections: FDA conducts inspections jointly with the States. Standards for the number of joint inspections 
vary with each partnership agreement. 
State Inspection Reports: FDA reviews State inspection reports. These reports vary according to a States laws and 
procedures. Standards for report submission vary with each partnership agreement. 
Annual Evaluations: FDA conducts an annual assessment jointly with the States. These evaluations are designed 
as an overall evaluation of the work accomplished. 
14 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  T H E  I M P O R T A N C E  O F  O V E R S I G H T  
An effective food safety system depends upon the collective effort among Federal and 
State government agencies.  States offer an important source of industry coverage, as well 
as front-line inspection expertise.  Federal oversight of State food firm inspections plays a 
key role to ensure the quality and uniformity among both Federal and State inspections. 
Below we identify and describe three fundamental factors that underscore the importance 
of FDA oversight of State food firm inspections. 
FDA relies heavily on State food firm inspections. 
States, through contracts and partnership agreements, inspect a greater number of 
food firms than FDA. 
In the past 3 years, the States conducted through contracts and partnership agreements, on

average each year, 61 percent of

food firm inspections recorded in

FDAs national database.  We found

that the States inspected an average

of 7,032 food firms per year, while

FDA inspected an average of 4,391

(see figure 1).  FDAs reliance on

State food firm inspections has

remained consistent over the past 10

years (see appendix E). 

We found several cases in which

FDA relies on States to inspect a

significantly higher proportion of

food firms.  In Texas, for example,

the State inspected 5 times as many

food firms as FDA did in 1998.16  In

Alaska, which accounts for over half
 Source: FDA 
of seafood processed in the United

States, FDA relies on the State to inspect all fishing vessels (about half of the seafood

industry in Alaska) and all food firms in remote areas.

In general, FDAs reliance on State inspections plays an important role in reducing

regulatory duplication among Federal and State food safety efforts, and in extending

FDAs inspection coverage of industries within States.

15 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  State inspections are increasingly focused on high-risk food firms. 
In response to our survey, 10 of the 17 FDA district offices overseeing contracts reported 
that, over the past 5 years, an increasing proportion of contracted food firm inspections 
have focused on high-risk food firms.17  Inspections of warehouses, which have been 
traditionally considered a low-risk type of food firm, have been almost completely 
eliminated from the State food contracts.  For fiscal years 1999 and 2000, FDA guidance 
calls for assignments to the States to emphasize high risk areas.  These include seafood, 
low-acid canned food, and microbiological health hazards. 
Under partnership agreements, an even greater number of inspections focus on high-risk 
food firms.  In response to our survey, 11 of 17 FDA district offices overseeing 
partnership agreements reported that more than half of the food firm inspections carried 
out by States under partnership agreements focused on high-risk food firms.  In a number 
of cases, inspections of high-risk food firms, such as those involving seafood and low-acid 
canned food, have shifted from contracts into partnership agreements.18 
FDA officials consistently reported that demands on inspection resources have 
necessitated increasing reliance on States to inspect high-risk food firms.  Indeed, States 
may have expertise and resources beyond that of FDA.  We were unable to obtain exact 
data on the risk-level of food firm inspections assigned to States because FDA lacks a 
systematic mechanism for assigning risk. 
State partnership 
agreements, which rely 
primarily on State 
authorities and 
resources, are becoming 
a significant source of 
food firm inspections. 
In 1998, about 43 percent

of the State food firm

inspections conducted in

association with FDA were

conducted through

partnership agreements. 

Over the past 10 years, the

number of contract

inspections has dropped by

45 percent.19  FDA has

Source: FDA 
relied heavily on

partnership agreements to

meet its inspection priorities and to maintain industry coverage.  In 1998, States

conducted nearly as many domestic food safety inspections under partnerships as FDA

did.20

16 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Partnership agreements, in large part, have arisen as a practical adaptation to resource 
constraints.  Over the past 10 years, funds to support the State food contracts have 
remained constant while the complexity and cost of food firm inspections has increased. 
We found that, with the addition of partnership inspections, States are conducting about 
the same proportion of inspections, relative to FDA, as they did a decade ago (see 
figure 2). 
States vary significantly in their inspection capacities. 
Based on data from our survey and from FDAs national database, we identified variation 
among State inspection programs along five key dimensions: inspection classifications, 
enforcement authorities, inspection authorities and regulations, inspector education and 
training requirements, and hours per inspection.21 
The variations among State inspection programs raise concerns about the quality and 
uniformity with which FDAs food inspections are carried out.  Under partnership 
agreements, which have become a significant source of State inspections, FDA relies fully 
on the States inspection authorities and resources.  The shift to a nationally integrated 
food regulatory system, under which States would take primary responsibility to inspect 
food firms, will make concerns about the consistency of State programs even more 
pressing in the coming decade. 
Variation in State inspection classifications. 
Based on our analysis of national inspection data, we found variation in State inspection 
classifications for contracted inspections.  Between 1996 and 1998, over half of the States 
failed to classify even one inspection as Official Action Indicated, which would indicate 
that serious violations were found during the inspection.22  During this same time period, 
two States classified almost one-fourth of their inspections as Official Action Indicated. 
We present the State-by-State variations in appendix F. 
Several factors may contribute to the variation in State inspection classifications for 
contracted inspections.  First, not all States conduct inspections of high-risk food firms. 
The States that conduct inspections of low-risk food firms could be less likely to find 
violations warranting severe classifications.  Because FDA does not have a mechanism to 
classify the risk of a food firm, there is no way to evaluate the impact of inspection risk on 
State inspection classifications.  Second, FDA district offices vary in their guidance to 
States in cases where the State has taken an enforcement action under its own authority. 
Some district offices may guide States to classify an inspection as No Action Indicated, 
while others may guide the State to use an inspection classification congruent with the 
States enforcement action.  These factors raise questions about the reliability of FDAs 
data on inspection classifications and enforcement actions taken by States on inspections 
conducted for Federal purposes. 
17 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Variation in State enforcement authorities. 
We identified wide variations in State enforcement authorities based on our State survey 
responses.  Eight of 36 States responding to our survey reported that they lack the 
authority to revoke a food firms permit or license; 13 States lack access to all firm 
records; and 2 States lack immediate embargo authority.  See appendix G for a 
distribution of State enforcement authorities. 
FDA itself lacks many of these important authorities.  It does not have the authority to 
revoke a State-issued food firm license; it cannot immediately embargo food suspected of 
being adulterated while conducting an inspection; and in most cases, it cannot review all of 
a food firms records without a Federal warrant.  In cases where such actions are 
warranted, FDA must rely on States.  It is a significant problem, however, when a food 
firms license needs to be revoked or a food product embargoed, and neither FDA nor the 
State have the authority to do so. 
Several Federal officials and consumer groups raised concerns about States willingness to 
take enforcement actions in the face of industry and economic pressures.  Their concerns 
were heightened for States that are economically dependent on food processing and 
manufacturing firms.  Some State officials we spoke with indicated that they prefer to let 
FDA take action in these sensitive situations. 
Variation in State inspection authorities and regulations. 
In our survey of State officials, 5 of 37 States reported that their laws and regulations are 
not equivalent to the Federal Food, Drug and Cosmetic Act; another 4 States reported 
that they have not adopted Good Manufacturing Practice laws equivalent to Federal 
standards.  The majority of other States operate under statutes containing language similar 
to Federal statutes. 
The lack of uniform regulations among States, and between FDA and the States, is of 
concern because it means that food firms are held to different inspection standards.  We 
identified, for example, a case in which FDA and a State differ in their implementation and 
interpretation of the Seafood HACCP inspection requirements with regard to what 
constitutes a hazard.  FDA requires that food firms identify the presence of undeclared 
allergens or have critical control points to ensure that their labels correctly declare such 
substances.  In evaluating a firms HACCP plan, FDA will ensure that the food firm has 
identified the hazard and has the appropriate controls in place.  By contrast, the State may 
check the food products label to ensure that all ingredients are listed but does not require 
the firm to identify allergens as a hazard in its HACCP plan or to have controls in place at 
a critical control point. 
Under contracts, States are required to conduct inspections in accordance with FDA laws 
and procedures.  Under partnership agreements, however, FDA has no authority to 
mandate that States use similar inspection criteria or that they rely on standard critical 
18 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  control points.  As one FDA official put it, when discrepancies are raised at regional 
meetings, the best FDA can do is simply agree to disagree with the States. 
Variation in State inspector education and training requirements. 
As food manufacturing and processing has become more complex and technical, inspector 
expertise and training is more pressing.  Twenty-three of 35 States responding to our 
survey require a college degree including science courses, which is equivalent to FDAs 
own standard.23  Eleven States have less stringent requirements.  These range from a high 
school diploma to a college degree without a science background.  The States responding 
to our survey also reported wide variation in the level of training provided to inspectors, 
ranging from fewer than 5 days per year to over 15 days.  See appendix H for a 
distribution of State inspector education and training requirements. 
FDA provides limited training for the States in the areas of manufacturing and processing 
inspections.  Such training must come out of the district offices own budgets.  In an era 
of diminishing resources, many district offices are hardpressed to find the resources to 
conduct such training.  Even when training is available, States are expected to fund their 
own travel costs.  Several States reported that limited funding and travel restrictions had 
routinely prevented them from attending FDA training. 
With the exception of the Seafood HACCP certification program, there is no national 
program to certify the competency of food inspectors.  A number of State and Federal 
officials pointed out that educational and training requirements are important, but that they 
do not guarantee an inspectors level of knowledge or his ability to incorporate inspection 
theory into practice.  FDA has begun to move in the direction of voluntary certification in 
its seafood HACCP program.  This certification program, which involves a written exam 
and an on-site performance review, has been well received by Federal and State 
inspectors.  Many view the Seafood HACCP certification program as an important step 
toward promoting uniformity and consistency in inspections. 
Variation in State inspection times. 
Based on our analysis of national inspection data, we found that between 1996 and 1998 
the average length of State contract inspections ranged from 2.8 to 9.5 hours among 
States.  The average time overall for States was 5.7 hours per contract inspection with a 
standard deviation of 1.5 hours.  The variation in State inspection times may be even 
greater under partnership agreements than under food contracts.  Under partnership 
agreements, the States follow their own procedures and use their own forms.  A number 
of State officials told us that they generally conduct shorter inspections than FDA, but at a 
higher frequency.  We present State-by-State variation in appendix F. 
A number of factors may influence the amount of time a State spends inspecting a food 
firm.  These include the complexity of the inspection, the firms size, the risk of the 
processing and manufacturing operations, and the inspectors familiarity with the food 
19 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  firm.  However, given the other evidence we present on variation among States, we raise 
concerns that the variations among inspection times may well indicate differences in the 
quality and thoroughness of inspections. 
Variation in State regulatory programs can inhibit commerce. 
The variation in State laws and inspection practices adds complications, costs, and 
frustrations for food firms engaged in multi-State commerce.  These firms are already 
subject to significant variation in inspection regulations and practices among the Federal 
food inspection agencies.  Industry representatives have expressed concern that an even 
heavier reliance on State inspections, such as under a nationally integrated regulatory 
system, could magnify the existing complications and costs.  They are calling for uniform 
laws and inspection standards across the nation and for strong Federal oversight as a 
means of fostering and maintaining consistency among State inspections. 
To our international trading partners, variation in State laws and inspection practices can 
undermine confidence in the uniformity of U.S. food standards and enforcement efforts. 
Some countries have raised concerns about discrepancies in U.S. food laws.  For example, 
FDA prohibits the sale of raw milk and unpasteurized cheese in interstate commerce; yet, 
at least one State allows the commercial sale of such products within its State borders. 
This discrepancy has resulted in tension between the U.S. and foreign trading partners 
wishing to import unpasteurized cheese.  Our foreign trading partners have also raised 
concerns about the lack of uniformity for inspections of imported products.  This problem 
may be exacerbated if imported products are inspected under the partnership agreement 
mechanism.24  Others have raised concerns that variation in State inspection practices and 
laws may lead some trading partners to concentrate imports in more lenient States. 
20 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  F I N D I N G S  
FDAs oversight of State food firm inspections is limited. 
Under contracts, FDA obtains minimal information to assess the quality of State 
food firm inspections. 
FDAs on-site audits have declined. 
On-site audit inspections are a key component of FDAs validation of State performance. 
Yet, over the past 5 years, FDA on-site audits dropped by 59 percent, from 253 in 1993 to 
104 in 1998 (see appendix I).25 
FDAs audit standards call for its district offices to conduct a level of audits proportionate 
to the number of inspections under each contract.26  Yet, the majority of district offices 
failed to meet these standards.  In 1998, 7 of the 17 district offices overseeing State food 
contracts did not conduct a single audit.27  Many of district office officials we spoke with 
did not view on-site audits as a priority.  In fact, many stressed that on-site audits were 
unnecessarily duplicative of State efforts. 
The distribution of audits is widely disproportionate among States with contracts.  In 
1998, FDA conducted over half of its audits in only 5 of the 38 States.  Those 5 States 
conducted just 13 percent of the total inspections conducted under contracts.  By contrast, 
FDA did not conduct a single audit in 21 of the 38 States holding contracts.  These States 
conducted over 50 percent of the contract inspections.  This pattern of disproportionate 
coverage has remained consistent over the last 3 years. 
FDAs on-site audits provide a limited basis for assessing State performance. 
FDA relies on independent and joint audits to assess the quality of State inspections. 
Independent audits, FDAs primary audit approach, are conducted up to 30 days after the 
States inspection.28  The purpose of these audits is to validate whether the States 
inspection findings match FDAs.  During the 30 days, however, conditions in the food 
firm may have changed, introducing a margin of error in the audit findings.  Furthermore, 
these audits focus on the accuracy of inspection findings and give little attention to how 
the State inspector drew conclusions.  Finally, FDAs approach to independent audits 
focuses on conditions in the food firm as a proxy for the performance of the State; the 
independent audit does not assess State performance directly. 
Despite FDAs reliance on the independent audits, district offices consistently reported 
that the joint audits were more useful to assess the quality of State inspections.  In 
contrast to the after-the-fact approach of the independent audits, the joint audits allow for 
FDA to directly observe State inspections and provide immediate feedback.  State officials 
21 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  also emphasized the benefits of joint audits in improving the quality of their inspections. 
Nevertheless, FDA provides limited guidance on how to conduct the joint audits.  Several 
FDA officials raised concern that FDA auditors, while trained to conduct inspections, lack 
important training and guidance on how to evaluate State performance. 
The lack of documentation further limits the effectiveness of audits as an assessment tool. 
At most, FDA auditors fill out a separate inspection report.  However, the auditor does 
not document an assessment of State performance.  As a result, FDA has a limited ability 
to review previous audit findings or to assure consumers, food firms, or international 
trading partners of its oversight. 
Finally, FDA may not be appropriately selecting its audits.  According to FDA guidance, 
audits should represent the types of inspections under contract.  Based on our site visits, 
however, we found that FDA selected food firms to audit largely based on a firms 
location and the auditors schedule.  Several FDA staff questioned whether the audits 
represent State inspections of the most complex and risky food firms. 
FDAs reviews of State contract inspection reports lack much rigor. 
During contract inspections, State inspectors complete a standardized inspection report 
documenting violations found during the inspection.  This information is essential for FDA 
to understand what took place during the inspection and the enforcement actions that are 
necessary.  FDA requires States to submit the contract inspection reports within 15 days 
of the completed inspection. 
In response to our survey, 14 of the 17 district offices overseeing contracts reported that 
they do not use any formal criteria to review the quality of State contract inspection 
reports.  Based on our site visits, we found wide variation among district offices in 
assessing these reports.  In one district office, the FDA reviewer skimmed every tenth 
report, focusing primarily on completeness of the forms.  Other reviewers conducted more 
detailed reviews of each report.  These reviews included, for example, assessing the 
inspectors ability to identify and clearly report violations found. 
FDA maintains national inspection data in its Program Operations Data System.  In the 
district offices we visited, only one reviewer made use of this database to analyze 
aggregate State inspection data.  While we recognize that this database contains limited 
information, it can be used to track basic trends in State work.  FDA is in the process of 
implementing a new Field Activity and Compliance Tracking System that will provide 
more specific information on State inspection results. 
FDA rarely seeks input from external sources to evaluate State performance. 
An important source of State evaluation can come from external sources, such as food 
firms, trade associations, or even consumer groups.  Such sources can provide information 
and perspectives that FDA inspectors would be hardpressed to match through audits and 
review of inspection reports alone. 
22 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  The FDA does not proactively solicit information from external sources.  For example, it 
does not take advantage of its public meetings, food safety hotline, and food safety 
websites as avenues for obtaining information about the quality of State inspections.  None 
of the district office officials we spoke with had ever contacted the trade associations or 
consumer groups in their area to learn about the quality of State inspections.  Instead, 
FDA district office staff told us that they typically rely on informal communications with 
industry officials at food-related conferences as their only source of external feedback. 
Industry surveys can be an important source of information about the performance of 
State inspectors.  Overall, however, the district offices have initiated little outreach of this 
type.  In recent years, at least one district office tried to survey food firms regarding the 
performance of its own inspectors.  It appears, however, that the Paperwork Reduction 
Act and the Federal Advisory Commission Act are factors inhibiting such efforts.29 
By contrast, each of the three States we visited routinely surveyed industry for feedback 
on the quality of their own inspections.  Below, we present several examples of questions 
posed in their surveys. 
State-Initiated Industry Surveys 
$ Was the inspector prepared and knowledgeable about your type of operation? 
$ Were the inspection findings adequately explained including the public health 
significance and the relationship to the law and regulations? 
$ Generally, Food Safety Program representatives offer options or provide 
assistance in correcting violations or problems: (Strongly Disagree-Strongly 
Agree) 
$ Inspection reports left by the Food Safety Program Representative are useful in 
correcting violations and problems: (Strongly Disagree-Strongly Agree) 
$ How do we rate on job knowledge? (Scale of 1-5, Poor to Excellent) 
Source: Texas Dept. of Health; Washington State Dept. of Agriculture; Maine Dept. of Agriculture 
23 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Under partnership agreements, FDA obtains even less information to assess the 
quality of State food firm inspections. 
Since their inception in 1994, partnership agreements have become a significant source of 
State inspections.  In 1998, these inspections accounted for 43 percent of the total State 
food firm inspections that FDA records in its national database.30  Under partnership 
agreements, States conduct their own inspections, which FDA accepts as equivalent to its 
own.  In many cases the partnership agreements involve inspections of higher-risk food 
firms than under contracts. 
FDA does not audit State performance, but participates in some joint partnership 
inspections with States. 
In contrast to the contracts, partnership agreements do not call for an on-site audit of 
State performance.  Instead, the partnership agreements call for FDA and State inspectors 
to conduct joint inspections.  There is no formal guidance on the purpose of these joint 
inspections.31  FDA and State officials we interviewed regarded joint inspections as a 
mechanism to provide on-site training and share inspection expertise among Federal and 
State inspectors.  They repeatedly emphasized to us that an FDA audit role was 
inappropriate for inspections accomplished through partnership agreements. 
The partnership agreements contain a wide range of expectations about the number of 
joint inspections to be conducted.  Among the five low-acid canned food partnership 
agreements we analyzed, the expectations ranged from one joint inspection per year with 
each inspector to joint inspections based on availability of personnel and agency 
priorities (see appendix J).  FDA only has uniform standards under its Seafood HACCP 
partnership agreements, where it calls for a minimum of 5 percent joint inspections. 
Based on our site visits, FDA district offices conducted fewer joint inspections than called 
for by the partnership agreements.  For example, in one district office, the States holding 
partnership agreements conducted over 500 Seafood HACCP inspections.  Yet, the 
district office conducted less than 5 joint inspections total.  This is less than one-fifth of 
the joint inspections called for by the Seafood HACCP partnership guidance document. 
FDAs reviews of State partnership inspection information are even more limited 
than its reviews of contract inspection information. 
The States submit widely varied levels of information about their partnership inspections. 
In contrast to the contracts, where FDA requires States to submit standardized inspection 
reports within 15 days of completion of an inspection, FDA district offices and States 
negotiate different levels of information sharing in each partnership agreement.  Our 
analysis of five low-acid canned food partnership agreements revealed expectations 
ranging from periodic inspection summary reports to the prompt exchange of full 
inspection reports (see appendix J).  Even in cases where FDA obtained full State 
inspection reports, the reports were based on the States own inspection procedures and 
24 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  codes.  In several cases these reports lacked elements required in FDAs inspection 
reports.  One State, for example, based its inspection report on a checklist that lacked 
elements to record observations of a firms processing methods and a narrative section to 
describe violations found during inspections. 
During our site visits, we identified a number of partnership agreements where FDA did 
not obtain enough information to assess the quality of State inspections.  In several 
seafood HACCP partnership 
agreements, for example, FDA 
did not obtain a narrative  The Oklahoma Pilot 
description of violations found. 
Without a narrative portion,  In 1994, FDA entered into a 5-year pilot partnership 
agreement with the State of Oklahoma, under which the 
FDA reviewers were unable to 
State conducts all of the food firm inspections within the 
assess the significance of 
State, including products subject to interstate commerce. 
violations or the thoroughness 
FDA does not conduct any inspections in the State. 
of the inspection.  Under the 
Oklahoma Food Safety  On a quarterly basis, Oklahoma submits a spreadsheet of 
inspection data. The spreadsheet provides only 
Partnership Agreement, which 
information on inspection results, and lacks information to 
is significant because the State 
assess the quality of inspections. 
has agreed to inspect 100 
percent of the food firms within  Outside of this spreadsheet, the partnership calls for an 
the State, FDA obtains  annual performance evaluation. Since 1995, however, 
extremely limited information  FDA has conducted only one performance evaluation of 
Oklahomas food manufacturing and processing 
to assess the quality of State 
inspections. A second audit is planned for fiscal year 
inspections (see box).32  While 
2000. In preparation for this audit, the FDA has offered 
this may represent an extreme 
several training courses to State inspectors. 
case, nevertheless it raises 
concern about the level of 
information FDA receives through the partnership mechanism. 
FDA has less accountability for the enforcement actions that States take under partnership 
agreements than it does for enforcement actions that States take under contracts.  Under 
contracts, FDA reserves the right to approve a States inspection classifications and 
enforcement actions, and to take action itself when necessary.  Under partnership 
agreements, however, FDA simply accepts the States inspection classifications and 
enforcement actions.  FDA does not outline clear expectations to share information about 
enforcement actions taken under partnership agreements (see appendix J).33  By contrast, 
FDA requires States to regularly submit full documentation of all enforcement actions 
taken under contract. 
25 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FDA provides limited feedback to States on the quality of their inspections. 
Two-way communication is an essential component of an effective oversight system.  The 
information that FDA obtains can provide an important source of evaluation for State 
programs.  Feedback is especially important to help States identify weaknesses and to 
improve the quality of inspections.  Feedback can also facilitate the exchange of expertise 
or resolve discrepancies between FDA and State policies. 
The majority of FDAs ongoing feedback to States relies on informal communication 
and individual district office initiatives. 
FDA does not routinely provide States with feedback concerning its on-site audits or 
reviews of inspection reports.  While feedback may occur informally over the telephone or 
in person, many of the State officials we spoke with told us that they would like to receive 
written feedback from FDA regarding the narrative portions of their inspection reports and 
the results of FDAs audits.  As we stated earlier in this report, FDAs assessment of the 
information it obtains through audits and inspection reports is limited. As such, the FDA 
has limited basis to provide States with useful feedback. 
Where FDA does provide feedback, it depends on initiatives of individual district offices. 
In one district office we visited, FDA provided States with a periodic assessment of 
problems found in their inspections reports.  The State officials reported that this feedback 
has helped to improve the quality of their inspections. 
FDAs performance evaluations provide States with little feedback about the quality 
of State inspections. 
The only formal mechanisms through which FDA documents its evaluation of State 
performance are a semi-annual State contract evaluation and an annual partnership 
evaluation.34  Based on our review, however, these evaluations provided limited 
assessment of the quality of State inspections. 
We found that 13 of the 34 semi-annual contract evaluations we analyzed for 1998 did not 
provide any assessment of State performance.  Fourteen of the 34 evaluations provided 
only minimal assessment of State performance, offering cursory and general comments 
such as overall history of performance has been good or no deficiencies reported.  Only 
seven of the evaluations provided more details in their assessment of State performance, 
such as problems found with inspection reports, or changes in State personnel that 
affected performance (see appendix K). 
FDAs annual partnership evaluations were equally limited in their assessment of State 
performance.  Ten of the 17 partnership evaluations we analyzed for 1998 contained broad 
summary statements of activities and little evaluation of the States performance.  For 
example, statements included Communication and coordination efforts between  parties 
were improved.  Resources were better utilized to meet goals of the partnership.  The 
26 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  goals of the partnership were met.  Seven of the annual evaluations provided more detail 
in their assessment of inspections accomplished.  These evaluations included comments 
that addressed in more depth, for example, the quality and consistency of inspections, the 
extent and nature of communication between the partners, and recommendations to 
improve work in the future.  Most of the district offices we interviewed seemed to regard 
the partnership evaluations as a means to communicate a summary of activities to 
headquarters, as opposed to a tool to evaluate State performance (see appendix L). 
The majority of States never received copies of the 1998 evaluations, further limiting their 
usefulness as tools for feedback.  In their survey responses, over two-thirds of the States 
holding contracts reported that they did not receive a copy of the semi-annual contract 
evaluations.  Over half of the States holding partnership agreements reported that they did 
not receive a copy of the annual partnership evaluations. 
FDAs feedback places little emphasis on improving the quality of State inspections. 
FDAs feedback is geared toward identifying deficiencies rather than toward enhancing 
State performance.  Generally, the States only hear from FDA regarding their performance 
if there is a significant problem.  Several State officials emphasized that FDAs 
assessments should include evaluation of both strengths and weaknesses. 
FDA is in a strategic position to observe best practices among the States and to 
disseminate this information widely.  Where FDA district offices have shown initiative in 
this direction, the results have been positive.  For example, one district office promotes 
information sharing through annual meetings and a monthly conference call.  Both the 
district office and the States report that these initiatives have facilitated communication 
and raised awareness of innovative practices.  FDA, however, does not generally take 
advantage of its position to facilitate this type of information sharing. 
. 
27 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FDA provides limited feedback to the public regarding its oversight of contracts 
and partnership agreements. 
Providing information to the public is an important mechanism through which government 
agencies can hold themselves and the bodies they oversee accountable.  With advances in 
information technology, it has become increasingly easy to provide the public with 
information.  FDA has several websites, a telephone hotline, and a facsimile information 
service through which it can make information available to the public. 35 
FDA does not make information available to the public about its reliance on State 
inspections or about State performance. 
Despite FDAs extensive reliance on States to inspect food firms, it shares little with the 
public about the extent and nature of its reliance.  The FDA website does not identify the 
States with which it holds contracts or the number and type of inspections that States 
conduct under contract.  The website provides slightly more information about partnership 
agreements, but lacks specific information such as the number and types of inspections 
conducted under each partnership agreement.  We called the FDA hotline to learn about 
State inspections conducted on FDAs behalf and were told that the only way to obtain 
such information was to contact the States directly or to submit a Freedom of Information 
Request. 
FDA provides no information to the 
The State of Alaska makes the following types 
public about its oversight or 
of information available on its website: 
assessment of State performance.  For 
example, FDA does not provide   	Percentage of domestic seafood production 
information about the mechanisms it  originating from Alaska and an overview of 
uses to oversee States nor the extent to  food facilities within the State. 
which it carries out these 
 Number of high-risk inspections accomplished 
responsibilities.  FDA does not make 
vs. number of inspections conducted based on 
available any assessment of State 
a risk model. 
performance and does not provide 
information about the results of State   Trends in violations and compliance actions. 
inspections conducted on its behalf. 
 Number of State and nation-wide deaths and 
By contrast, a few States are posting 
illnesses associated with food products. 
performance measures on their own 
State websites (see box.) 
Source: www.state.ak.us:80/dec/deh/safefood.htm, 12/6/99 
Consumer advocates and industry 
representatives repeatedly told us that they would like more information about FDAs 
reliance on States and the mechanisms through which FDA oversees these inspections. 
Such information would provide an important source of FDA accountability to the public. 
28 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  FDA faces significant barriers in overseeing State food firm 
inspections 
Low priority of food safety inspections. 
No statutory requirement exists for FDA to inspect a minimum number of food firms, as 
there is in other programs within FDAs purview, such as inspection of mammography 
facilities. In developing its work priorities, FDA must allocate resources to the mandatory 
inspection areas first.  The resources that remain go to the non-mandatory programs, such 
as food firm inspections.  Over the past decade, FDAs regulatory responsibilities have 
increased, while FDAs resources have not kept pace.  Without mandatory requirements 
to conduct food inspections, resources to conduct these inspections have diminished.  For 
example, the number of operational full time equivalents in the district offices have 
declined in almost all food areas, excluding fish and fishery products.36 
Within the food inspection program, resources to conduct oversight of the State food firm 
inspections compete with FDAs own inspection resources.  At present, FDA manages to 
inspect only a small fraction of the food firms under its own purview.37  In developing its 
annual work plans, FDA does not set aside resources to conduct oversight.  In response to 
the limited resources available for oversight, a number of district offices have spread 
oversight responsibilities, previously held by one supervisor, to several FDA inspectors. 
Many of these inspectors carry full inspection loads, leaving little time for oversight. 
Limited leverage to oversee partnership agreements. 
The majority of State and Federal officials we spoke with were uncomfortable with the 
concept of  FDA overseeing the partnership agreements.  Many of them underscored the 
fact that States agreeing to conduct inspections under partnership agreements are doing 
FDA a favor by helping the agency to extend its inspection coverage at a low cost. 
Several officials also pointed out that the basic principle of partnerships, whereby each 
partner accepts the others work as equal, contradicts the need for Federal oversight. 
Because FDA is not paying its partner States to conduct inspections, it has limited ability 
to require States to submit information, to provide critical feedback on inspections 
conducted, or to facilitate change in the States inspection habits.38  This concern is 
heightened under Seafood HACCP inspections, where States may not be adequately 
shifting from inspections focusing on basic observations of sanitation to a science-based 
assessment of a food firms hazard prevention and control processes. 
FDAs oversight of partnership agreements is further weakened by its lack of incentives to 
terminate partnership agreements.  Because FDA cannot afford to conduct these 
inspections itself, there is little incentive to terminate the partnership agreements. 
Furthermore, in contrast to the contracts, there are few financial consequences for States 
that do an inadequate job of inspecting food firms. 
29 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Reductions in training and agency expertise. 
In the past decade, formal classroom training for FDA inspectors declined significantly. 
We found that training hours received by FDA personnel decreased by 41 percent between 
1992 and 1998.  In 1992, FDA personnel received 23,749 hours of training; in 1998, FDA 
personnel received 13,992 hours.  Where training has been provided, it focused on 
Seafood HACCP, as opposed to manufacturing and processing inspections. 
In a number of States, the FDA is conducting only a minimal number of inspections.39 
FDA district office officials consistently raised concerns about whether they were retaining 
enough workload to ensure program area competence.  FDA has not set forth a minimum 
level of Federal inspections to be conducted in each State.40  Several officials within FDA 
were concerned that agency expertise is unevenly distributed throughout the country. 
FDAs diminishing inspection expertise raises concern about its effectiveness in overseeing 
the States. 
Limited accountability of FDA district offices. 
FDA has set forth general guidelines for its oversight of State food firm inspections, but 
has few mechanisms to ensure the uniformity and effectiveness of the oversight carried out 
by district offices.  FDA does not provide audit training for FDA inspectors nor does it 
have mechanisms to ensure that audits are carried out appropriately.  Annually, FDA 
headquarters compiles a summary of audits conducted by the district offices.  In the past 
few years, however, many district offices have not submitted this information to 
headquarters.  Furthermore, FDA lacks a system for district offices to track time they 
spend on oversight activities.  As a result, FDA headquarters is unable to hold district 
offices accountable for how effectively they deploy their limited resources. 
Lack of important enforcement authorities. 
FDA lacks the authority to revoke a food firms license, to immediately embargo food 
suspected of being adulterated, and to access all of a food firms records without a Federal 
warrant.  Most States have access to these authorities.  FDA consistently relies on States 
to take such actions, because they are subject to fewer legal and administrative loopholes, 
and because States can often take action more quickly. 
Several FDA and State officials have raised concerns that FDAs reliance on State 
enforcement authorities compromises its ability to be critical of State inspections.  On the 
one hand, FDA needs to ensure the adequacy of State inspections.  On the other, it needs 
to maintain a good relationship with the States.  In our 1991 report on food safety 
inspections, we raised concerns about the adequacy of FDAs enforcement tools and the 
negative ramifications of FDAs reliance on States.41  In 1999, the Canadian Food 
Inspection Agency also raised concerns about FDAs limited powers and its reliance on 
State enforcement authorities.42 
30 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  R E C O M M E N D A T I O N S  
Key Role of State Government 
State governments play a critical role in ensuring the safety of the nations food supply, 
both under their own authorities and in concert with FDA through contracts and 
partnership agreements.  They provide valuable resources and expertise that serve as a 
complement to FDAs own inspection efforts.  Our recommendations recognize and build 
on the importance of this State role. 
Template for Reform 
For State inspections carried out under FDA auspices, it is essential that FDA provide 
effective oversight to ensure both the quality and uniformity of inspections.  FDA brings 
important strengths to this oversight role through a tradition that emphasizes science-
based research and a public health perspective.  Moreover, on the front-lines FDA 
oversight is carried out by many knowledgeable and dedicated staff.  We met many of 
them and were impressed by their commitment to food safety. 
But our review has revealed major shortcomings in FDAs current system for overseeing 
State food firm inspections.  In this section, we recommend actions FDA can take to 
address these shortcomings and to develop a system of oversight that holds the States 
more fully accountable for the inspections they conduct in association with FDA.  Our 
recommendations are based on a template of effective oversight that includes the 
following seven key elements. 
Template For Effective FDA Oversight 
of State Food Firm Inspections 
U Equivalency: Equivalency in Federal and State safety standards, inspection 
programs, and enforcement practices. 
U On-site Audits: An effective on-site mechanism for evaluating State inspection 
performance. 
U Inspection Information: Routine submission of standardized information on 
State inspections. 
U External Sources: Information from varied external sources on State inspection 
performance. 
U Feedback to States: Substantive and timely FDA feedback to States on 
inspection performance. 
U Internal Capacities: Enhanced FDA capacities to conduct effective oversight. 
U Public Information: Proactive public disclosure of inspection and oversight 
information. 
31 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  The specific recommendations that flow from this template are in accord with the National 
Academy of Sciences call for a Federal food safety system with well defined 
accountability and responsibility for each partner in the system.43  The Academy calls 
for FDA to devote more attention to building and carrying out an effective oversight 
system.  FDA itself, through the Center for Food Safety and Applied Nutrition, has made 
the evaluation of State inspection programs a top agency priority for the year 2000.44  We 
recognize that in an environment of limited resources and competing priorities, such 
attention is not easily or readily provided.  However, we feel that oversight is a critical 
area that FDA should not neglect.  These recommendations should be viewed as a 
blueprint for action that can be carried out over a period of time. 
In the following pages, we elaborate on the seven elements in the template.  We begin, 
however, by offering a caution concerning FDAs reliance on partnership inspections.  The 
partnership agreements, as we have indicated earlier, have grown to account for 43 
percent of the State food firm inspections conducted in association with FDA. 
An Initial Caution:  FDA should reevaluate its dependence on 
partnerships as a mechanism for conducting inspections. 
FDAs increased reliance on partnership inspections is understandable.  In an environment 
of limited resources, it is a practical way of extending inspection coverage at little cost. 
FDA provides the States with certain benefits, mainly in the form of training or technical 
assistance, and the States agree to conduct inspections at their own cost. 
But the operational reality is disturbing.  The inspections that States carry out under 
partnership agreements are primarily inspections that they already conduct under their own 
State requirements.  In most cases, State officials felt that they were doing FDA a favor by 
including inspections under the partnership agreements, a feeling which FDA district office 
officials were well aware of.  Thus, FDA is not in a position to exert much leverage in 
overseeing the inspections.  In fact, both FDA and State officials tend to see FDA 
oversight of partnership inspections as an anomaly in what they regard as a partnership of 
equals. 
We suggest that current conditions are counter to effective FDA oversight of partnership 
inspections.  FDA uses partnership agreements as vehicles to accept State inspections as 
equivalent to its own.  While many of the State inspections may well be of high quality, 
FDA is not in a position to adequately assess their quality or equivalency.  For its 
oversight to be credible, it must be able to offer such attestation.  If FDA moves in the 
directions we call for below, then the time will come when partnership agreements can 
serve more reliably as a mechanism for FDA-State collaboration. 
In the recommendations that follow, we take the position that a two-tier FDA system of 
oversight is inappropriate.  Oversight geared to partnership inspections must be just as 
effective as that geared to contract inspections.  While there can be some differences in 
approaches, FDA must be able to assure consumers that its commitment to safety is no 
32 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  less under one mechanism than the other.  And, similarly, it must assure industry officials 
and international trading partners that its commitment to quality and uniformity is 
independent of the vehicle through which inspections are conducted.  Thus, we offer our 
recommendations as actions FDA can take to hold States more accountable for food firm 
inspections conducted under both contracts and partnership agreements. 
Recently, FDA assigned the Office of Regulatory Affairs Federal-State Field Advisory 
Committee the task of developing acceptable language for the oversight of partnership 
inspections for inclusion in the partnership guidance document.  We encourage this 
committee to address the concerns and recommendations highlighted in this report. 
Recommendation 1.  FDA should work with the States to 
achieve basic equivalency in food safety standards and laws, 
and in inspection programs and practices. 
In many respects, a common set of standards for industry to comply with and for State 
and Federal inspectors to apply in their inspections provides an essential foundation for 
effective oversight.  FDA oversight of State inspections has only limited value without a 
common frame of reference. 
Standards for State inspection programs already exist in several areas of our nations food 
safety system.  The Department of Agriculture has program standards for States 
participating in its meat and poultry inspection program.  The Conference for Food 
Protection recently established voluntary standards for retail food inspection programs. 
These standards are now being tested in six States. 
The National Uniform Criteria work group within the National Food Safety System 
(NFSS) project is exploring national standards that would achieve uniformity among food 
safety programs.  We recognize that FDA and the States face a number of barriers in 
moving toward greater consistency and uniformity in food safety inspection and 
regulation.  We encourage FDA to continue to take leadership in working with the States 
and the NFSS project national work groups to accelerate progress in this direction. 
1a.  Pilot test a system audit as a mechanism to foster equivalency and evaluate 
State capacity and performance. 
A system audit is a comprehensive review that focuses on a States capacity to conduct 
food safety inspections and effectively oversee its own program.  It can also add depth to 
FDAs oversight and allow for somewhat less emphasis on audits of individual State 
inspections.  The Food Safety Inspection Service of the Department of Agriculture has 
moved in this direction with its oversight of meat and poultry programs. 
For a system audit to work as an FDA tool of oversight, however, a State must have, or 
be ready to develop, standards, regulations, and inspection approaches substantially 
equivalent to those of FDA.  The Role and Responsibilities work group within the NFSS 
33 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  project has made considerable progress in developing a model for a system approach to 
oversight.  The work group has prepared a document, Evaluation of Regulatory Food 
Safety Systems as Part of a Nationally Integrated Food Safety System, which has been 
forwarded to the Federal agencies involved and the Presidents Food Safety Initiative.  We 
applaud this work as an important reference point in developing an appropriate oversight 
model and encourage further work in this direction. 
If FDA were to find two or more States willing to test the system audit approach, the 
parties could work to advance equivalency and improve oversight.  One possibility would 
be for FDA to work with one State that has laws and approaches that are similar to FDA 
and another State that lacks equivalency but is willing to work toward it.  The results of 
the test could provide a laboratory for how best, over time, to integrate a system audit into 
FDAs oversight. 
Recommendation 2.  FDA should devote high priority to 
improving its on-site audit mechanism for evaluating the 
effectiveness of State inspections. 
This is a matter of considerable importance warranting immediate attention.  The on-site 
audit of State inspections serves as the core of FDAs oversight and evaluation efforts and 
is likely to do so for some time to come.  That core is deficient. 
Given the importance of the on-site audit, FDA may wish to contract for some outside 
assistance in carrying out this function.  But over time, and in the interest of developing a 
nationally integrated food safety system with State agencies playing key roles, it is clearly 
desirable to strengthen FDAs in-house capabilities to assess how well States conduct 
inspections.  Below we address policy changes FDA should take governing the nature and 
frequency of on-site audits.  In each case, FDA has recently undertaken some initiatives 
that move in the direction we call for.  In the following three sections, we briefly elaborate 
on these initiatives. 
2a.  Stress joint audits rather than independent audits as the primary mechanism 
to conduct on-site reviews of State inspection performance. 
Our analysis leads us to recommend that FDA rely on the joint audit as its major approach

to on-site reviews.  The joint audit allows an FDA inspector to assess first-hand the

performance of the State inspector and to offer immediate feedback.  This approach has

considerable support among both FDA district offices and State officials.

This emphasis on joint audits, we should note, need not preclude some use of independent

audits.  FDA should still conduct periodic independent audits on both a 

for-cause as well as a random basis.  They can serve as a valuable, albeit secondary,

component of a strengthened oversight system.

In a February 18, 2000 memo to the field, the Associate Commissioner for Regulatory

34 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  Affairs called for a focus on joint audits for fiscal year 2000.  While this action is not yet 
part of FDAs audit policy, it represents a significant shift away from FDAs current 
emphasis on independent audits.  We encourage FDA to evaluate the implementation of 
this new approach to develop an appropriate audit strategy. 
2b.  Develop guidance that provides clear and firm direction on the essentials of 
FDA on-site audits. 
Given the shift we recommend toward a focus on joint audits and the limited training that 
has been offered to FDA inspectors in audit and evaluation methodologies, we recommend 
that FDA develop a guidance document on the essentials of on-site audits.  Such guidance 
can serve as a basis for training and as a reference point for FDA in evaluating State 
performance.  It will be essential to establishing uniformity among district office audits and 
to reaching uniformity across States. 
This guidance document should clarify and specify the auditing role that FDA inspectors 
play and the performance criteria that FDA inspectors should use to evaluate State 
inspections.  In contrast to the current standards, which focus narrowly on the accuracy of 
State inspection findings, FDA should develop criteria that provide a comprehensive 
review of State performance.  FDA guidance should also clarify how its inspectors can 
document their assessment of State performance and the manner, nature, and timing of the 
feedback that FDA provides to States about the on-site audits.  In developing this 
guidance, FDA could consider similar guidance manuals that it uses for other programs, 
such as those currently used in the Mammography Quality Standards Act program.  For 
example, FDA may want to create a checklist that Federal auditors can use in evaluating 
the quality and performance of State inspections. 
FDA should seek input from its State counterparts in developing guidance about the on-
site audits.  State input is vital to developing sound performance criteria.  As States and 
the Federal government move toward greater uniformity in their standards and practices, 
the on-site audit mechanism can spur consistency among food inspections. 
In at least one State, the FDA is currently developing a pilot field audit program that will 
require Federal auditors to utilize an audit evaluation form when conducting a joint audit. 
We encourage FDA to evaluate the effectiveness of this audit guidance and form and, if 
effective, to consider employing it more broadly in its oversight of State inspections. 
2c.  Determine the appropriate minimum frequency for on-site audits. 
For the on-site audits to serve as an effective tool of oversight, FDA must conduct them

often enough and regularly enough for the States to take notice of FDAs presence and for

FDA to obtain sufficient information to assess the adequacy of the States inspections. 

We documented the reduced frequency of FDAs on-site audits for contract inspections

and their uneven distribution across States.  We also identified the infrequency and

variation in joint inspections undertaken through partnership agreements.

35 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  We recognize that, in large measure, the frequency of on-site audits is a function of 
available resources.  The same resources that the district offices draw upon to conduct 
these audits must also be used for many other activities, including FDAs own food firm 
inspections and inspections in other program areas, such medical devices and blood banks. 
We urge that FDA, in assessing its various priorities, provide clearer direction in defining 
an appropriate minimum number of on-site audits, for both contract and partnership 
inspections, and then hold the district offices accountable for meeting the minimum. 
Given that FDA relies on States for the majority of its food firm inspections, oversight 
deserves considerable attention.  Without regular on-site audits, FDAs oversight will lose 
credibility and its capacity to attest to the quality and uniformity of State inspections will 
erode. 
In its recent memo to the field, the FDA also called for joint audits for 5 percent of the 
inspections assigned to States under contract for fiscal year 2000.  Further, the memo 
further called for all State inspectors to have at least one joint inspection over the next 
three years.  We encourage these efforts and urge FDA, over the coming years, to 
evaluate the implementation of these strategies for the most effective use of resources.45 
Recommendation 3.  FDA should require that States 
routinely provide FDA with standardized information on the 
inspections they conduct. 
Beyond on-site audits, a second key source of information is FDAs on-going review of 
inspection reports.  In collecting such information, FDA must seek to minimize the 
reporting burden on the States, but at the same time ensure that it has a core of 
information to provide effective oversight.  Our recommendations may require contractual 
changes, but most certainly will require changes in the partnership agreements. 
3a.  Define a minimum set of information to collect from the States on inspections 
conducted under both contracts and partnership agreements. 
The information that FDA obtains about partnership inspections is highly variable and 
depends on the States own policies and practices.  In contrast, FDA obtains standardized 
information about contract inspections.  This information includes contract inspection 
reports with narrative portions, information to assess a firms compliance with FDA 
regulations, and a detailed description of a food firms manufacturing processes.46 
We recommend that FDA define the core set of information it regards as essential for 
oversight of State food firm inspections and then require that States provide it under both 
contract and partnership agreements.  We urge that State enforcement actions be part of 
that essential core.  At present, FDA lacks information about enforcement actions that 
States take under their own authority for contract inspections.  FDA almost always lacks 
such information with respect to partnership inspections since enforcement actions under 
that arrangement are typically taken under State authority.  For FDA to assess how and 
how well States are performing, it must be fully and accurately informed on the extent and 
36 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  type of enforcement actions the States take.  We urge FDA to use information that will be 
available through the Field Activity and Compliance Tracking System to analyze and track 
enforcement actions taken by States for inspections conducted in association with FDA. 
3b.  Provide guidance to district offices addressing the extent and nature of their 
reviews of State inspection reports. 
In its guidance, FDA should provide a framework for how the district offices can best 
review inspection reports submitted by States.  The guidance could address how and how 
often the offices might review individual inspection reports.  FDA should establish uniform 
criteria by which all district offices should evaluate the quality of State inspection reports. 
As with the criteria to assess State performance during audits, the criteria to review these 
reports should provide a level of accountability and a mechanism for providing the States 
with feedback.  Again, we encourage FDA to seek input from States regarding review 
criteria that would be most useful to improve their programs. 
We also urge FDA to provide guidance to the district offices on how best to use existing 
data sources to complement their ongoing reviews of State inspections reports.  The data 
that is collected and stored in the Program Operations Data System (PODS) can help 
district offices and States identify trends in State inspection practices and opportunities for 
improvement.  We recognize that the current PODS database is somewhat limited, and 
thus we encourage FDAs shift to a new system called the Field Activity and Compliance 
Tracking System (FACTS) database.  This system will provide considerably more 
information that will enable FDA, for instance, to track the types of violations found and 
the types of enforcement actions taken.  We are aware that the FACTS system is designed 
to accommodate enforcement actions that are characteristic of FDAs regulatory process. 
To the extent that State enforcement processes are different from FDAs, some 
redesigning of FACTS could be necessary.  We urge FDA to consider how it can use the 
FACTS system to maximize efficiency in its oversight efforts. 
Recommendation 4.  FDA should draw on multiple external 
sources of information in assessing State inspection 
performance. 
In its recent report on improving food safety, the National Academy of Sciences called for 
FDA to ally with non-federal partners, including the food industry and consumer groups.47 
The perspectives of external sources can be a valuable complement to the information that 
FDA obtains from its on-site audits and review of inspection reports. 
4a.  Solicit feedback from industry, consumer, and other groups on the adequacy 
of State inspections. 
FDA could transform many of its existing outreach mechanisms into avenues for public 
feedback on the quality of State inspections.  For example, FDAs food safety website is 
37 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  an ideal forum through which to solicit external perspectives.  FDA could create a 
separate section on its website for feedback on State inspections.  Another avenue for 
obtaining feedback would be through public meetings.  FDA could explicitly ask for 
comment on State performance or it could arrange to hold regular focus groups with 
industry and consumer groups. 
In addition, FDA may want to consider developing a national feedback survey for food 
firms involved in interstate commerce.  It could require State inspectors to leave these 
feedback forms at the firms that they inspect in association with FDA.  Many States are 
already employing such surveys under their own auspices.  An option FDA may want to 
consider is requiring that States conducting their own industry surveys share results with 
FDA. 
Recommendation 5.  FDA should provide substantive and 
timely feedback to States on their inspection performance. 
The prior three recommendations addressed the information sources upon which FDA 
should rely.  But getting the information is insufficient if FDA fails to foster improvements 
and take corrective actions where necessary.  It is particularly important in this regard for 
FDA to provide the States with regular, substantive feedback on what it has learned about 
their performance.  In carrying out this recommendation, FDA will need to make changes 
in the language of the contracts and partnership agreements.48  These documents should 
establish clearer and more uniform guidelines for providing regular and substantive 
feedback to the States. 
In a February 18, 2000 memo to the field, the Associate Commissioner for Regulatory 
Affairs called for district offices to provide the results of the document reviews and joint 
audits to the States in writing at the completion of reviews or at least quarterly.  While this 
clearly demonstrates a concerted step to improve feedback, we urge FDA to further its 
efforts in accord with recommendations below. 
5a.  Provide the States with ongoing and written feedback on the on-site audits it 
conducts. 
At present, FDAs formal feedback from audits is geared toward identifying deficiencies 
rather than enhancing State performance.  To the maximum extent possible, the audits 
should be redirected to serve as a vehicle to help States improve and maintain good 
performance.  When FDA inspectors conduct these audits, whether on a joint or 
independent basis, they should in each case prepare a summary assessment to give to the 
State.  That assessment should assist in fostering continuous improvement in State 
inspection efforts.  The report should reflect, as we discussed previously, standard 
performance criteria that provide States a useful basis to assess and improve their own 
performance. 
38 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  5b.  Provide States with periodic evaluations that assess the States overall 
performance. 
As we have noted, the annual and semi-annual evaluation reports that FDA district offices 
now prepare are more of an accounting of activities than a mechanism for accountability 
or improvement.  We suggest that the time and resources spent on these evaluations could 
well be redirected.  FDA should reevaluate the purpose of these reports and consider 
either enhancing their substance or eliminating them all together.  In any case, the 
emphasis should turn to more flexible, ongoing evaluations. 
As FDA develops and improves its database of information on State inspection activities, 
it should draw on that, its on-site audit reports, and external sources of information to 
engage in continuing assessments of State inspection performance.  These assessments 
should not just concern individual inspections but should also provide a comprehensive 
evaluation of State performance.  FDA can help the States by providing them with 
summary data, thereby enabling them to assess not only their own performance but also 
how they compare with other States.  FDA should determine appropriate cycles in which 
to provide this aggregate feedback. 
5c.  Promote information exchange on promising approaches of State programs. 
FDA has exposure to food safety inspections conducted throughout the nation, and, as 
such, is in prime position to disseminate information about promising approaches.  At 
present, there are limited means for States to communicate among themselves and learn 
from best practices and experiences of other States.  FDA could play a pivotal role in 
facilitating communication among States.  For example, FDA could foster communication 
by using its website, organizing an electronic communication forum among State agencies, 
or initiating telephone conference calls in various regions.  The promotion of voluntary 
best practices is in line with the actions items called for by the Presidents Council on 
Food Safety in the Draft Preliminary Food Safety Strategic Plan.49 
Recommendation 6.  FDA should enhance its internal 
capacities to conduct effective oversight. 
We have called for a demanding and complex oversight agenda for FDA.  To carry it out, 
FDA must remain attentive to the distinctive characteristics of individual State 
governments, keep abreast of changing technologies in food processing and 
manufacturing, stay informed on the international and other forces stressing equivalency in 
food safety systems, and maintain respect for an enduring national ethic that calls for the 
minimum necessary regulation. 
Thus, we call upon FDA to appropriately equip itself.  We urge that FDA consider the 
ways in which it needs to bolster its own capacities.  Below, we outline four actions that 
FDA can take toward that end. 
39 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  6a.  Ensure inspector competence in both inspection and audit functions. 
The credibility of the oversight process rests in large measure on the knowledge and skills 
of the FDA inspectors in the district offices.  But with diminished training time for FDA 
inspectors and with increased regulatory responsibilities in an array of programs, FDA 
inspectors are increasingly challenged to maintain their expertise in food science 
technology and in techniques of assessing a food firms processes and products.  We 
recommend that FDA respond to these pressures by seeking to buttress the valuable base 
of in-house expertise it has in food safety. 
As important as the latter is, there is another training area that may well warrant even 
more attention: evaluation and auditing.  Expertise in conducting food safety inspections is 
essential to performing the on-site audit role for which we have called.  But alone it is 
insufficient.  To conduct oversight, FDA inspectors must develop an evaluation mind-set 
and learn how to go about evaluating performance.  Traditionally, FDA inspectors have 
not received training of this kind.50 
One element that FDA might wish to consider as it upgrades its training is a certification 
program for FDA inspectors who audit State performance.  This would be a way of 
adding some rigor and substance to the oversight role.  Furthermore, this type of 
certification program is in line with the action items called for by the Presidents Council 
on Food Safety in the Draft Preliminary Food Safety Strategic Plan.51 
6b.  Hold district offices more accountable for their performance in overseeing 
State food firm inspections. 
Just as FDA must play a leading role in holding States accountable for meeting standards, 
so too must FDA hold its own district offices accountable.  The move toward quality and 
uniformity must be apparent across district offices as well as across States. 
FDA should address key questions about the effectiveness of district office oversight: 
How effective are the district offices in conducting on-site audits?  How effective are the 
district offices in reviewing State inspection reports?  Do the district offices provide useful 
feedback to the States?  FDA should work with the district offices to determine the best 
possible ways of answering such questions. 
In holding the district offices more accountable for their performance, FDA headquarters 
is in a strategic position to foster continuous improvement among the district offices.  For 
example, FDA headquarters could share trend data with the 20 district offices about State 
performance and about issues and problems that the district offices have detected.  FDA 
headquarters could also facilitate information sharing about innovative practices among 
the district offices. 
6c.  Ensure the systematic identification of all food firms in interstate commerce. 
Without access to information in a national registry, FDA must rely on a patchwork of 
40 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  State information to identify the food firms it should oversee.  This heightens FDAs 
dependence on the States and impedes both its oversight and its own inspection efforts.  In 
our 1991 report we recommended that FDA develop or maintain a single national registry 
or require that each State maintain its own registry and share information with FDA.52  We 
reiterate the need for FDA to have a more reliable mechanism for identifying the food 
firms under its purview. 
6d.  Seek broader FDA enforcement authorities. 
Many States have enforcement authorities that FDA lacks.  This imbalance inhibits further 
progress toward national uniformity and hinders Federal oversight because it contributes 
to FDAs dependence on the States.  Among the enforcement authorities that would seem 
to be important are those that would allow inspectors to immediately embargo suspected 
adulterated products, to review all necessary records without a Federal warrant, and to 
photograph suspected violations.  In our 1991 report on food safety, we also called for 
FDA to obtain these authorities.53 
Recommendation 7.  FDA should increase public disclosure 
of its oversight of State food firm inspections. 
An important mechanism of accountability is public disclosure of information.  Through 
greater disclosure, FDA can reinforce that States are accountable for the quality of food 
safety inspections that they conduct for national purposes. 
We urge FDA to proactively make information available about its reliance on State 
inspections and its mechanisms for overseeing State inspections.  While this information is 
accessible through a Freedom of Information Act request, consumers would have a 
difficult time even knowing what to ask for.  We recommend that the FDA make the 
following information available on its food safety website, its telephone hotline, or its fax 
information service: 
C	 The extent and nature of FDAs reliance on State inspections through 
contracts and partnership agreements:  FDA could identify States with which 
it holds partnership agreements and contracts.  It could provide information 
regarding the number and type of inspections and the risk of food firms being 
inspected by States under these arrangements.  FDA could also provide 
information on the ratio of food firms inspected by FDA versus the States. 
C	 The extent and nature of FDAs oversight of State inspections:  FDA could 
be more explicit about its mechanisms to oversee State inspections and the extent 
to which it has carried out these responsibilities. 
C	 State performance:  FDA could make available its assessments of State 
performance.  This could include both assessments made during audits as well as 
reviews of the States inspection reports.  FDA could also make available its 
41 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  annual assessments of State performance.  It could consider developing a list of 
State programs that meet certain performance standards.54 
C	 Inspection results:  FDA could make available aggregate information of State 
inspection results.  This could include a summary of inspection classifications and 
trends in critical violations and compliance actions taken.  FDA could take similar 
steps to make the results of its own inspections available. 
42 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  COMMENTS ON THE DRAFT REPORT 
We received written comments on the draft report from the Food and Drug 
Administration (FDA), the Association of Food and Drug Officials (AFDO), the National 
Food Processors Association (NFPA), the National Fisheries Institute (NFI), and the 
Center for Science in the Public Interest (CSPI). 
In general, the report was well received by each of the groups.  Below, we summarize the 
major comments and, in italics, offer our responses. We incorporated several changes in 
the final report, most of which were technical in nature.  The full text of each set of 
comments is included in appendix M. 
The Food and Drug Administration 
The FDA welcomes our report as a tool to strengthen Federal oversight of State food firm 
inspections.  The agency stresses that States can effectively augment Federal inspection 
capacity and that States provide a valuable source of inspection coverage and expertise. 
In general, FDA agrees with our recommendations and points to a number of recent 
initiatives underway that move in the direction we call for.  We refer to many of these 
initiatives in our text.  In response to the concerns we raise regarding oversight of the 
partnership agreements, the FDA agrees that it must fundamentally modify the nature of 
these agreements. 
In two areas of our recommendations, the FDA does not agree with the activities we 
suggest.  First, FDA does not agree that it should draw on external sources of information 
to assess State inspection performance.  The agency believes that its own audit process is 
the best way to assess State performance.  Second, the agency does not directly address 
some of the specific and near-term actions we call for to increase public disclosure of its 
reliance on, and oversight of, State inspections.  Instead, the agency references a future 
performance assessment of State programs and public disclosure of those performance 
assessments via the Internet. 
We recognize that FDA is dealing constructively with many of the shortcomings we 
identify in our report.  We encourage the agency to continue to do so and to prioritize 
resources to meet its oversight goals.  We also urge the agency to reconsider the value of 
external sources of information to assess State performance.  We continue to believe that 
such information can serve as an important complement to FDAs own audit information. 
On the matter of publicly disclosing information, we urge FDA to take immediate action 
to post State inspection performance information.  Such information could include 
identification of the States with which FDA holds a contract or partnership, the number 
and types of inspections under each arrangement, the ratio of FDA-to-State inspections 
in particular States, and the FDAs assessments of State performance through audits or 
periodic performance evaluations. 
43 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  The Association of Food and Drug Officials 
The AFDO strongly supports Federal oversight of State food firm inspections.  It agrees 
with the major thrust of our recommendations and feels that our report is generally on 
target.  The AFDO  underscores the importance of the Federal-State alliance and the role 
that States can and should play in developing an oversight system.  However, the AFDO 
also raises a number of issues related to FDAs oversight.  Among the issues raised, three 
areas are particularly prominent. 
On the issue of State inspection capacities, the AFDO emphasizes that the expertise of 
many State programs exceeds the expertise in the FDA district offices.  The AFDO raises 
concern about FDAs loss of institutional memory and questions whether all FDA 
district offices are currently in a position to adequately judge the quality and uniformity of 
State inspections.  The AFDO also points out that, although documentation may be 
sparse, FDA district office staff are often in contact and familiar with the abilities of 
various State programs.  Furthermore, many of the State officers are commissioned by 
FDA and therefore conduct Federal inspections, not merely State contract inspections. 
On the issue of resources, the AFDO points out that our recommendations will require 
considerable resources on the part of State programs.  The oversight expectations we call 
for will require incentives that reward States for maintaining and improving their 
programs.  In particular, AFDO warns that under partnership agreements, whereby FDA 
extends its inspection coverage for next to nothing, States may choose not to participate 
rather than accept additional reporting requirements. 
Finally, the AFDO underscores the work of the Roles and Responsibilities work group 
within the National Food Safety System project as an important reference point that FDA 
may want to consider in redesigning its oversight of State food firm inspections.  The 
AFDO underscores the importance of programmatic oversight as more effective than 
oversight based on audit inspections alone.  The AFDO also raises concern that our 
recommendations do not adequately address how oversight can go beyond identifying 
problems to providing a mechanism to improve performance. 
We are pleased that the AFDO agrees with the major thrust of our recommendations.  On 
the issue of State food safety expertise, we recognize that the lack of FDA oversight does 
not necessarily indicate the lack of a strong State program.  Our report underscores the 
importance of a strong system of Federal oversight in order to assure consumers, 
industry, and foreign trade partners about the quality and uniformity of food safety 
regulation across the nation.  A system based on informal communication among Federal 
and State agencies does not carry adequate assurance that such a safety system exists.  In 
regards to the concern raised about the expertise of all FDA district offices to assess 
State performance, we recommend that the FDA ensure inspector competence in both 
inspection and audit functions.  We recognize that such expertise is critical to the 
credibility of the oversight process. 
44 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  On the matter of resources, we recognize that States are performing inspections under 
partnership agreements for little cost to FDA.  In our report, we urge FDA to reevaluate 
its reliance on the partnership agreements as an appropriate mechanism to accept State 
inspections.  We continue to believe that, regardless of the mechanism through which 
FDA accepts State inspections, the oversight of partnership inspections must be just as 
effective as that of contract inspections. 
Finally, we recognize the important work currently underway in the Roles and 
Responsibilities work group within the National Food Safety System (NFSS) project.  We 
have modified the text of our report to more fully reflect the work of NFSS work groups 
as potential reference points in developing an appropriate oversight system.  We also 
recognize the value of a systems approach to oversight of States capacities, laws, 
regulations, and abilities.  To start, we recommend that FDA pilot a system audit with 
States willing to develop standards, regulations and inspection approaches substantially 
equivalent to FDAs own.  In response to the contention that our recommendations focus 
on oversight mechanisms that merely identify problems with State performance, we 
believe we place considerable emphasis on feedback mechanisms that would improve 
State performance. 
National Food Processors Association 
The NFPA recognizes the extensive role that States play in food safety and the importance 
of strong Federal oversight as a means to achieve uniformity and quality in the regulatory 
landscape.  The NFPA, however, views the need for oversight even more broadly than we 
define it in the report.  It points to the wide variation in food safety expertise and auditing 
styles among the FDA district offices and suggests that a review function be established 
within the FDA to provide greater oversight of its own inspectors and audits. 
In general, NFPA agrees with most of our recommendations and shares our concerns 
regarding accountability in the food inspection system.  The only recommendation that 
NFPA disagrees with is our recommendation to provide FDA with additional legal 
authorities.  It believes that the agencys current authorities are sufficient to assure a 
continuous safe food supply.  The NFPA supports our recommendation that FDA draw on 
external sources of information in assessing State performance.  In fact, it urges the 
recommendations to go even further, by requiring that both State and Federal inspections 
be subject to feedback from external parties. 
We continue to believe that additional FDA enforcement authorities are a vital 
component of effective oversight.  We, along with other groups, raise concern that FDAs 
reliance on States enforcement actions may compromise FDAs ability to be critical of 
States performance.  We believe that NFPA raises an important issue concerning 
variation in food safety expertise, and inspection and audit practices among FDA district 
offices.  We agree that the credibility of an effective oversight system rests in large 
measure on the knowledge and skills of the FDA inspectors in the district offices.  We 
recommend that FDA develop a training course for its own inspectors in both inspection 
and audit functions. Finally, we are pleased that the NFPA agrees with our 
45 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  recommendation to include external sources of information as a key component of an 
effective oversight system.  We encourage the FDA to develop as transparent an 
oversight system as possible. 
National Fisheries Institute 
The NFI agrees with the major portions of our findings and recommendations.  In 
particular, the NFI emphasizes the importance of external perspectives on the oversight 
process, which can augment the limited number of FDA on-site audits.  The groups also 
strongly supports the shift from independent to joint audits as a more effective and less 
burdensome oversight tool for both the State and Federal inspectors, as well as for 
manufacturers.  Finally, the group reiterates the importance of Federal and State food 
safety expertise, and encourages that the current voluntary Seafood HACCP certification 
program become mandatory in the future. 
The NFI agrees with most of our recommendations except for two areas.  First, the NFI 
does not support the need for additional FDA enforcement authorities.  The group 
believes that the FDA generally receives adequate enforcement support from States when 
necessary.  Second, the NFI supports limited disclosure of State inspection information, 
but is concerned about the possible misinterpretation of detailed inspection results. 
We are pleased with the broad support from NFI regarding the importance of an effective 
oversight system and the role of many of our recommendations.  On the issue of FDA 
enforcement authorities, we continue to believe that these authorities are a critical 
component of an effective oversight system.  We do not believe that FDA should rely on a 
patchwork of State authorities to accomplish actions that it deems necessary.  On the 
issue of public disclosure of State inspection and performance information, we do not 
recommend that FDA make the results of specific inspections publicly available.  Instead, 
we recommend that FDA, at a minimum, publish aggregate information, such as a 
summary of inspection classifications and trends in critical violations. 
The Center for Science in the Public Interest 
The CSPI strongly supports our report, but does not feel that we went far enough with 
our recommendations.  The group expresses concern with FDAs reliance on State 
partnership inspections and with the reallocation of duties from the Federal to State 
governments. The CSPIs comments point out vulnerabilities and potential weaknesses in 
State inspection programs, such as the potential influence of State politics and economics 
on regulatory oversight.  The group suggests that FDA should restrict reliance on States 
to low-risk inspections. 
The scope of our study was to assess the extent and nature of FDAs oversight of State 
food firm inspections.  We did not set out to determine the appropriate balance of 
inspection duties among the Federal and State governments, nor to define the 
appropriate balance between contracts and partnerships.  However, we do emphasize 
that FDA should assure consumers that its commitment to food safety is no less under 
46 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  partnership agreements than under contracts.  In our report, we document variation 
among States in order to emphasize the importance of Federal oversight in supporting 
uniformity and quality in its program.  We recognize that States have important expertise 
and resources in food safety; in some cases, State capacities may exceed those of FDAs. 
We support collective efforts among Federal and State agencies for an effective food 
safety system that maximizes resources. 
47 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX A 
Overview of States Holding 

Contracts and Partnership Agreements

Fiscal Year 1998

State  Number of  Number of 
Contracts  Partnership Agreements 
Alabama  1  -
Alaska  1  1 
Arizona  - 1 
Arkansas  1  -
California  - 3 
Colorado  1  1 
Connecticut  1  -
Delaware  - -
Florida  1  1 
Georgia  1  1 
Hawaii  - -
Idaho  1  -
Illinois  1  1 
Indiana  - 1 
Iowa  1  -
Kansas  1  -
Kentucky  1  -
Louisiana  1  1 
Maine  1  1 
Maryland  1  1 
Massachusetts  1  1 
Michigan  1  2 
Minnesota  1  1 
Mississippi  1  2 
Missouri  1  -
Montana  1  -
Nebraska  1  -
Nevada  - -
New Hampshire  - -
New Jersey  1  1 
New Mexico  - 1 
New York  1  1 
North Carolina  1  1 
48 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX A 
State  Number of  Number of 
Contracts  Partnership Agreements 
North Dakota  1  -
Ohio  1  -
Oklahoma  - 1 
Oregon  1  1 
Pennsylvania  - 2 
Rhode Island  1  1 
South Carolina  2*  -
South Dakota  - -
Tennessee  1  2 
Texas  1  2 
Utah  - -
Vermont  - -
Virginia  1  1 
Washington  1  1 
West Virginia  2*  1 
Wisconsin  1  2 
Wyoming  1  -
Puerto Rico**  1  -
Total = 51  40 contracts (38 States)  37 partnerships (29 States) 
* The Department of Health holds one contract, the Department of Agriculture holds the other. 
** One territory holds a food inspection contract. 
49 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX B 
Types of Partnership Agreements, Fiscal Year 1998

Seafood HACCP Partnerships: 
1. Alaska

2. California

3. Colorado

4. Georgia

5. Louisiana

6. Maine

7. Maryland

8. Minnesota

9. Mississippi

10. New Jersey

11. New Mexico

12. New York

13. North Carolina

14. Oregon

15. Pennsylvania

16. Tennessee

17. Texas

18. Virginia

19. Washington

20. Wisconsin

Low-Acid Canned Food and Acidified Food Partnerships: 
21. Illinois

22. Pennsylvania

23. Tennessee

24. Texas

25. West Virginia

Cheese and Dairy: 
26. Michigan

27. Wisconsin 

Other: 
28. Arizona - Raw agricultural products

29. California - Raw agricultural products

30. California - Exotic Game Facilities

31. Florida - Blue Crab Partnership

32. Indiana - Food Safety

33. Massachusetts - Inspection/samples 

34. Michigan - Pilot Cider HACCP 

35. Mississippi - Sandwich

36. Oklahoma - Food Safety

37. Rhode Island - Inspection/samples

50 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX C 
FDA District Offices Overseeing 

Contracts and Partnership Agreements

Fiscal Year 1998

FDA District Office  Number of Contracts  Number of Partnership 
Agreements 
Atlanta District  4  2 
Baltimore District  4  3 
Chicago District  1  1 
Cincinnati District  2  ---
Dallas District  2  3 
Denver District  2  2 
Detroit District  1  3 
Florida District  1  1 
Kansas City District  4  ---
Los Angeles District  --- 4 
Minneapolis District  3  3 
Nashville District  2  2 
New England District  4  3 
New Jersey District  1  1 
New Orleans District  2  3 
New York District  1  1 
Philadelphia District  --- 2 
San Francisco District  --- * 
San Juan District  1  ---
Seattle District  5  3 
Total = 20 FDA district offices  40 contracts  37 partnerships 
(17 FDA district offices)  (17 FDA district offices) 
51 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX D 
Methodology

We collected information presented in this report from the following sources: 
FDA 
Program Operation Data System (PODS).  We analyzed national food firm inspection data 
over a 10-year period spanning 1989 to 1998.  We reviewed the number and types of FDA 
inspections and the number and types of State contract and partnership agreement 
inspections.  We analyzed State contract inspection classifications and time spent on 
contract inspections.  We also reviewed the hours of training received by FDA inspectors 
between 1989 and 1998. 
FDA Audit Summary Data.  We reviewed summary audit data between 1993 and 1998. 
We analyzed the number of joint and independent audits conducted by FDA district offices 
in each of the States holding contracts.  We compared the numbers of audits conducted to 
the standards in FDAs Field Management Directive No. 76. 
Food Contracts and Partnership Agreements.  We requested from FDA headquarters 
copies of all of the food contract and partnership agreements active in 1998.  We received 
40 of the 40 State food contracts, and 23 of the 37 partnership agreements pertaining to 
food firm inspections (FDA district offices reported in our survey that they held this number 
of active partnership agreements during 1998).  We reviewed the contracts and partnership 
agreements for expectations regarding oversight, submission of State inspection and 
enforcement information, and FDA feedback to the States. 
FDA Evaluations of State Contracts and Partnership Agreements.  We requested and 
reviewed semi-annual contract evaluations and annual partnership evaluations for 1998.  We 
received 34 of 40 contract evaluations and 17 of 37 partnership evaluations for 1998.  We 
assessed these documents for the depth of comments pertaining to State performance. 
FDA Oversight Directives and Guidance Documents.  We reviewed FDAs Field 
Management Directive No. 76 audit guidance for evaluation of State contract inspectional 
performance.  We reviewed the Model Partnership Agreement Guidance Document (ORA-
21) and the Model Seafood HACCP Partnership Agreement, FDAs guidance document for 
the development and oversight of partnership agreements. 
OIG Mail Surveys 
FDA District Offices.  We surveyed all 20 district offices.  We received 100 percent 
response rate.  The survey addressed the following areas: oversight of the State food 
52 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX D 
contracts, oversight of the State food partnership agreements, challenges facing FDA in 
overseeing State contracts and partnerships, and recommendations for improving oversight. 
States.  We surveyed all 40 State agencies holding food contracts.  We received 37 
responses, a 92 percent response rate.  The survey addressed the following areas: 
background information on the State food firm inspection programs, FDA oversight of the 
food contracts and partnership agreements, challenges facing State food inspection 
programs, and recommendations to improve FDA oversight. 
OIG Field Work 
Site Visits to FDA District Offices.  We conducted site visits to three geographically 
diverse FDA district offices.  Each of the district offices held both contracts and partnership 
agreements with States.  The emphasis of the visits was on understanding the extent and 
nature of FDAs oversight and the barriers that FDA faces in carrying out that oversight. 
Site Visits to States.  We conducted site visits to three geographically diverse States.  Each 
State was affiliated with one of the FDA district offices we visited and held at least one 
contract and one partnership agreement.  The emphasis of the visits was on understanding 
the States experiences with FDA oversight, their internal oversight mechanisms, and their 
recommendations for improving FDA oversight. 
Audit Observations.  During our site visits to the FDA district offices, we observed three 
FDA audits of State performance.  We observed an independent audit of a seafood firm, a 
joint audit of a low-acid canned food firm, and a joint audit of a pasta firm.  Our purpose 
was not to evaluate the FDAs audit of State performance, but rather to observe the way in 
which FDA inspectors conducted audits. 
Stakeholder Interviews 
We interviewed representatives of organizations we considered to be stakeholders in food 
safety oversight.  These stakeholders included food safety experts, consumer groups, and 
industry groups. 
Other Documents 
In addition to the documents referenced above, we reviewed statutes and regulations, FDA 
work plans and priority-setting agendas, reports by external agencies, and relevant literature. 
53 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX E 
FDA and State Inspections 

in Foodborne Biological Hazards (Project 03)

Fiscal Years 1989-1998

Fiscal  FDA Food Firm  State Food Firm  State Food Firm  Total Food Firm 
Years  Inspections  Inspections under  Inspections  Inspections 
(number and  Contract  under Partnership 
percent of total) 1  (number and  Agreement 
percent of total)  (number and 
percent of total) 
1989  4524 (38 %)  7507 (62 %)  -- 12,031 
1990  3896 (36 %)  7071 (64 %)  -- 10,967 
1991  6618 (46 %)  7697 (54 %)  -- 14,315 
1992  4332 (37 %)  7441 (63 %)  -- 11,773 
1993  3884 (36 %)  7017 (64 %)  -- 10,901 
1994  3555 (39 %)  5530 (61 %)  -- 9,085 
1995  3517 (39 %)  5392 (61 %)  -- 8,909 
1996  3669 (42 %)  5047 (57 %)  95 (1 %)  8,811 
1997  3901 (31 %)  4991 (40 %)  3643 (29 %)  12,535 
1998  5603 (43 %)  4155 (32 %)  3165 (25 %)  12,923 
2186  3417  3881  274  2247  918  8314  4609 
Regular  Seafood  Regular  Seafood  Regular  Seafood  Regular  Seafood 
HACCP  HACCP  HACCP  HACCP 
Source: FDA Program Operations Data System 
1  For FDA Inspections from 1989-1992, we adjusted the number to compensate for the cooperative 
program inspections that moved out of the 03 project category and into their own project category in 1992. In sum, 
we subtracted the 03026 (A-E) PACS from the FDA food firm inspections in the years 1989-1992. 
54 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX F 
State Contract Inspection Data

in the Foodborne Biological Hazards (Project 03)

Fiscal Years 1996-1998

State  Total  Average  Inspections  Inspections  Inspections 
Number of  Number of  resulting in  resulting in  resulting in 
Inspections  Hours per  No Action  Voluntary Action  Official Action 
Inspection  Indicated (NAI)  Indicated (VAI )  Indicated (OAI) 
Alabama  274  7.16  47.1%  52.2%  0.7% 
Alaska  155  3.71  73.5%  25.8%  0.7% 
Arkansas  467  2.85  59.5%  39.2%  1.3% 
Colorado  248  9.50  19.77%  76.6%  3.6% 
Connecticut  109  5.47  53.2%  46.8%  0.0% 
Florida  626  3.36  19.7%  70.6%  9.7% 
Georgia  173  5.73  25.4%  73.4%  1.2% 
Idaho  199  7.70  76.9%  23.1%  0.0% 
Illinois  700  6.61  83.0%  16.9%  0.1% 
Iowa  150  6.14  13.3%  86.0%  0.7% 
Kansas  83  5.78  31.3%  67.5%  1.2 % 
Kentucky  220  7.15  68.2%  31.4%  0.4% 
Louisiana  567  6.18  42.0%  58.0%  0.0% 
Maine  151  6.09  78.8%  21.2%  0.0% 
Maryland  431  4.43  94.2%  5.3%  0.5% 
Massachusetts  378  3.81  18.8%  80.2%  1.0% 
Michigan  512  6.15  45.3%  48.6%  6.1% 
Minnesota  455  5.23  56.0%  41.3%  2.6% 
Mississippi  72  4.27  13.9%  86.1%  0.0% 
Missouri  161  6.53  19.9%  73.9%  6.2% 
Montana  187  4.11  73.8%  26.2%  0.0% 
55 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX F 
State  Total  Average  Inspections  Inspections  Inspections 
Number of  Number of  resulting in  resulting in  resulting in 
Inspections  Hours per  No Action  Voluntary Action  Official Action 
Inspection  Indicated (NAI)  Indicated 2 (VAI 2)  Indicated (OAI) 
Nebraska  170  4.53  72.3%  27.7%  0.0% 
New Jersey  1009  7.19  17.2%  82.8%  0.0% 
New York  641  4.83  5.6%  70.8%  23.6% 
North  437  7.38  39.1%  58.6%  2.3% 
Carolina 
North Dakota  115  4.11  9.6%  90.4%  0.0% 
Ohio  712  4.72  29.2%  70.7%  0.1% 
Oregon  461  7.35  39.3%  60.1%  0.6% 
Puerto Rico  165  4.94  3.03%  95.2%  1.8% 
South  193  8.64  10.9%  89.1%  0.0% 
Carolina 
Tennessee  347  4.71  87.0%  12.1%  0.9% 
Texas  917  7.92  29.0%  46.0%  25.0% 
Virginia  510  6.24  86.1%  10.0%  3.9% 
Washington  693  5.70  65.5%  33.6%  0.9% 
West Virginia  284  4.67  31.7%  75.0%  6.3% 
Wisconsin  859  6.80  70.8%  29.0%  0.2% 
Wyoming  40  4.68  90.0%  10.0%  0.0% 
Source: FDA Program Operations Data System 
Note: We excluded Rhode Island from our analysis because the State did not hold a contract for the duration of 
fiscal years 1996-1998. 
Definitions: FDA uses three primary classifications for inspections: Official Action Indicated, which signifies 
serious violations found during an inspection leading to a recommendation for regulatory or administrative 
sanctions; Voluntary Action Indicated, which signifies some deficiencies found during an inspection, but not 
significant enough to warrant regulatory or administrative sanctions (any corrective action is left to the firm to take 
voluntarily). Note: This category represents our analysis of VAI2' classifications; and No Action Indicated, which 
signifies that minor or no deficiencies were found during an inspection and that a routine reinspection is 
recommended. 
56 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX G 
FDA and State Enforcement Authorities 

for Overseeing Food Firms

Authority  Percentage of States  FDA Authority 
with Authority (N=36) 
License/ permit revocation  28 (77.7%)  No 
Civil monetary penalties  26 (72.2%)  No 
Immediate Embargo  34 (94.4%)  No 
Recall  16 (44.4%)  Voluntary 
Seizure  28 (77.7%)  Yes 
Injunction  31 (86.1%)  Yes 
Prosecution  31 (86.1%)  Yes 
Access to all firm records in  22 (61.1%)  No 
question 
Use of photographic  23 (63.8%)  No 
equipment during inspection 
Source: Office of Inspector General Mail Survey, August 1999. 
States with Multiple Enforcement Authorities 
Number of Authorities*  Number of States holding 
these authorities (N=36) 
1 1 (2.7%) 
2 --
3 2 (5.5%) 
4 2 (5.5%) 
5 4 (11.1%) 
6 5 (13.8%) 
7 7 (19.4%) 
8 7 (19.4%) 
9 8 (22.2%) 
Source: Office of Inspector General Mail Survey, August 1999. 
* These include license revocation, civil monetary penalties, immediate embargo, recall, seizure, injunction, 
prosecution, access to all firm records in question, and the use of photographic equipment during inspection. 
57 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX H 
Educational and Training Requirements

for State Food Inspectors

Minimum Educational  States (N=35) 
Requirements 
High school diploma  4 (10.8%) 
High school diploma with college- 2 (5.4%) 
level science courses 
College Diploma  5 (13.5%) 
College Diploma with science  23 (62.2%) 
courses 
Other  1 (2.7%) 
. 
Source: Office of Inspector General Mail Survey, August 1999
Number of Days of Formal  States (N=36) 
Training 
5 days or less  8 (21.6%) 
6-10 days  18 (48.6%) 
11-15 days  5 (13.5%) 
More than 15 days  5 (13.5%) 
. 
Source: Office of Inspector General Mail Survey, August 1999
58 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX I 
FDA Audits of State Food Contracts

Number of  Number of  Number of 
FDA Audits  Contract  States receiving 
Inspections  at least one audit 
FY 93  253  7354  34/39 (87%) 
FY 94  139  5801  26/40 (65%) 
FY 95  135  5661  24/40 (60%) 
FY 96  140  5312  25/38 (66%) 
FY 97  120  5231  17/38 (45%) 
FY 98  104  4252  17/38 (45%) 
Source: FDA 
59 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX J 
Partnership Agreement Expectations:

Comparison of Five Low-Acid Canned Food 

Partnership Agreements

We analyzed five low-acid canned food partnership agreements for their expectations in five key 
areas: inspection reports, joint inspections, enforcement actions, training, and assessment 
mechanisms.  These partnerships were active at some point during fiscal years 1996-1998.  Low-
acid canned food firm operations are generally considered high-risk and complex, heightening the 
importance of effective FDA oversight. 
State  Submission of  Submission of  FDA-State 
Inspection Reports  Information about  Training 
Enforcement Actions 
California   Summary inspection   Enforcement actions,   Not addressed. 
reports only; full inspection  if requested. 
reports upon request. 
 No report elements 
specified. 
 Periodic exchange. 
New Jersey   Inspection reports.   Not addressed.   Training as 
 No report elements  needed. 
specified. 
 No time frame specified. 
Illinois   Inspection reports.   Not addressed.   Training as 
 No report elements  needed. 
specified. 
 No time frame specified. 
Pennsylvania   Inspection reports.   Enforcement actions.   Training will 
 No report elements   Prompt exchange.  depend on 
specified.  availability of 
 Prompt exchange.  personnel and 
resources. 
Texas   Inspection reports.   Enforcement actions.   Training will 
 No report elements   Summary reports may  depend on 
specified.  also be prepared.  availability of 
 No time frame specified.   No time frame  personnel and 
specified.  resources. 
60 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX J 
Partnership Agreement Expectations:

Comparison of Five Low-Acid Canned Food 

Partnership Agreements 

(Continued)

State  Number of Joint  FDA-State Assessment Mechanisms 
Inspections 
Interim Evaluation  Final Evaluation 
California   Not addressed.   Not addressed.   Final evaluation criteria 
not specified. 
New Jersey   Joint inspections   Interim evaluation   Final evaluation should 
as needed.  should track number of  analyze inspection findings 
inspections, cost, and  and regulatory actions. 
classifications. 
Illinois   Joint inspections   Interim evaluation   Final evaluation criteria 
sufficient to train  should track number of  not specified. 
two inspectors.  inspections, 
 Subsequently, at  classifications, and 
least one joint  training; establish 
inspection per year  database of adverse 
with each  findings; and calculate 
inspector.  cost per inspection. 
Pennsylvania   Joint inspections   Not addressed.   Not addressed. 
as necessary. 
Texas   Joint inspections   This agreement does   Final evaluation criteria 
upon request,  not require in-process  not specified. 
based upon  measurements. 
availability of 
personnel and 
agency priorities. 
61 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX K 
Contract Semi-Annual Report

The FDA evaluates State inspection performance under contract twice a year in its semi-annual 
reports. The semi-annual report contains three primary sections.  Section A includes the number 
of joint and independent audit inspections accomplished during the reporting period and the 
number of deficiencies uncovered in those audits.  Section B includes details of deficient 
performance, assessment of the cause of the problem, and solutions planned or accomplished. 
Section C provides space for FDA district offices to comment on overall contract performance, to 
highlight significant State accomplishments or actions, and to raise questions and concerns. 
For our review, we asked the Division of Federal-State Relations to provide us with all State 
contract semi-annual reports for fiscal year 1998.  We received reports for 34 of the 40 contracts. 
These 34 contracts covered 3351 food sanitation inspections in fiscal year 1998.  We analyzed the 
semi-annual reports along the following dimensions: the number of audits conducted, the number 
of deficiencies found, and the extent of comments on State performance.  We categorized 
comments about State performance in one of three ways, as defined below: 
Definitions: 
a. No Assessment: The semi-annual report contains no comment regarding State 
performance or the quality of inspections. 
b. Minimal Assessment: The semi-annual report contains vague, broad statements of State 
performance with few details that describe the quality of State inspections or other 
information relevant to State performance. 
c.  Some Assessment: The semi-annual report includes examples on which to base FDAs 
assessment of State performance.  This may include analysis of violations identified and 
inspection classifications or enforcement actions taken.  The report may also include 
information on training conducted or changes in the States personnel that affect the States 
performance. 
62 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX K 
Analysis of Contract Semi-Annual Reports (FY 1998)

State  Number  Number of  Number of  Comments on State Performance 
of Joint  Independent  Deficiencies 
Audits  Audits  No  Minimal  Some 
Assessment  Assessment  Assessment 
AK  1  0  0  X 
AL  0  5*  0  X 
AR  0  1  1  X 
CO  0  0  0  X 
CT  0  2  2  X 
FL  0  0  0  X 
GA  0  0  0  X 
ID  4  7  0  X 
KS  0  0  0  X 
KY  8  4  0  X 
LA  0  4*  0  X 
ME  0  0  0  X 
MI  0  3  0  X 
MN  0  0  0  X 
MO  3  0  0  X 
MS  0  0  0  X 
MT  2  0  0  X 
ND  0  0  0  X 
NE  0  0  0  X 
NJ  0  9  0  X 
NY  0  0  0  X 
OH  0  5  0  X 
63 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX K 
Analysis of Contract Semi-Annual Reports (FY 1998)

(Continued)

State  Number  Number of  Number of  Comments on State Performance 
of Joint  Independent  Deficiencies 
Audits  Audits  No  Minimal  Some 
Assessment  Assessment  Assessment 
OR  3  0  0  X 
PR  0  0  0  X 
SC - Dept.  8  0  0  X 
Of 
Agricultur 
e 
SC - 0  0  0  X 
Dept. of 
Health 
TN  0  4*  0  X 
TX  0  0  0  X 
VA  0  10  0  X 
WA  6  0  0  X 
WI  0  0  0  X 
WV - 2  3  0  X 
Dept of 
Agricultur 
e 
WV - 4  8  0  X 
Dept of 
Health 
WY  0  0  0  X 
TOTALS  41  65  3  13  14  7 
(N = 34) 
Note: We received no information from FDA regarding State food sanitation contracts with the States of Illinois, Iowa, 
Maryland, Massachusetts, North Carolina, and Rhode Island. 
* It is unclear from the semi-annual reports whether the audits conducted were joint or independent. We listed them as 
independent audits, because according to the FMD-76, that is the primary evaluation mechanism for the food sanitation 
contract. 
64 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX L 
Annual Partnership Evaluation

The Partnership Agreement Guidance Document (ORA -21) calls for annual evaluation of partnership 
agreement activities.  These annual evaluations are conducted jointly by FDA district offices and 
States.  The FDA district offices submit copies of these evaluations to headquarters. 
The annual partnership evaluation form (attachment C of the ORA-21) contains 10 elements.  Four of 
these elements are particularly relevant to evaluating the quality and effectiveness of work performed 
under partnership agreements.  These include Outputs (e.g. number of inspections, number of people 
trained), Outcomes (e.g., what was the result, benefit to partners), Evaluation of Partnership 
Agreement (e.g. strengths and weaknesses, positives and negatives), and Recommendations. 
For our review, we asked the Division of Federal-State Relations to provide us with copies of all of 
the fiscal year 1998 partnership agreement evaluations pertaining to food firm inspections.  We 
received 17 evaluations of 37 partnership agreements reported by district offices as active during fiscal 
year 1998.  We analyzed these evaluation documents according to the following dimensions:  the 
extent of comments on State performance, whether there were comments on FDA performance, and 
whether there were critical comments regarding the partnership activities.  We provide definitions of 
these categories below. 
Definitions: 
Comments on State Performance: 
a. Minimal Assessment: Contains vague, broad statements of State performance with few details 
that describe the quality of State inspections or other information relevant to State performance. 
b.  Some Assessment: Includes examples on which to base FDAs assessment of State 
performance.  This may include analysis of violations identified and inspection classifications or 
enforcement actions taken.  The report may also include information on training conducted or 
changes in the States personnel that affect the States performance. 
Comments on FDA performance: Contains information on the quality of FDA inspections 
conducted. 
Critical Comments: Contains critical comments including comments about problems encountered, 
solutions identified, and recommendations to improve performance. 
65 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX L 
Analysis of Partnership Evaluations (FY 1998)

State  Comments on State Performance  Comments on  Critical Comments 
FDA 
Minimal  Some Assessment  Performance 
Assessment 
CA  X  no  no 
GA  X  no  no 
IL  X  no  no 
LA  X  no  yes 
ME  X  no  no 
MI  X  no  yes 
MS (sandwich)  X  no  no 
MS (seafood)  X  no  yes 
NY  X  no  no 
NC  X  no  no 
OK  X  no  no 
PA  X  no  yes 
TN  X  no  no 
TX (seafood)  X  no  yes 
TX (low-acid  X  no  no 
canned food) 
WI (seafood)  X  no  no 
WI (cheese)  X  no  yes 
Totals  10  7  Yes = 0  Yes = 6 
(N = 17)  No = 17  No = 11 
66 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX M 
Full Text of Comments on the Draft Report

PAGE 
Food and Drug Administration  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  68

Association of Food and Drug Officials  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  76

National Food Processors Association . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  84

National Fisheries Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  87

Center for Science in the Public Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  94

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FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX N 
Endnotes

1. World Health Organization Press Release, WHO Responds to New Challenges in Food 
Safety, January 25, 2000. 
2. Paul S. Mead, et al., Food-Related Illness and Death in the United States, Emerging 
Infectious Diseases 5 (September-October 1999) 5: pp. 607-625.  The estimates of foodborne 
illness cited are more than twice as high as those suggested in earlier studies, which put the figure 
for foodborne illness at 30 million. 
3. Food and Drug Administration, Food Safety Inspection Service, and Center for Disease 
Control and Prevention, Healthy People 2000: Status Report Food Safety Objectives, 
(September 1, 1999). 
4. Donna U. Vogt, Food Safety Issues in the 105th Congress, Congressional Research Service 
Issue Brief, (August 11, 1998), p. 2. 
5. Institute of Medicine, National Research Council, Ensuring Safe Food from Production to 
Consumption (Washington: National Academy Press, 1998). 
6. United States Environmental Protection Agency, United States Department of Health and 
Human Services, and United States Department of Agriculture, Food Safety From Farm to 
Table: A National Food Safety Initiative, (Report to the President, May 1997). 
7. Two States, South Carolina and West Virginia, hold two contracts each.  In each State, one 
contract is held by the Department of Health, the other by the Department of Agriculture. 
8. The Presidents Food Safety Initiative is supporting, among other activities, the establishment 
of a consortium in which all Federal agencies with risk-management responsibilities will improve 
the quality of risk-assessment for foods. 
9. The FDA district offices oversee State contracts in accord with the Field Management 
Directive No. 76 (October 24, 1995); FDA district offices oversee the partnership agreements in 
accord with the Office of Regulatory Affairs Partnership Agreement Guidance Document 
(January 23, 1996). 
10. The seven principles are:  (1) analyze hazards, (2) identify critical control points to control 
identified hazards, (3) establish the point at which a preventive action must be taken, (4) establish 
procedures to monitor the control points, (5) establish corrective actions to be taken when 
monitoring shows that a critical limit has not been met, (6) establish procedures to verify that the 
system is working consistently, and (7) establish effective record keeping to document the 
96 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX N 
HACCP system. 
11. National Food Safety System Project work groups: 1. Roles and Responsibilities, 2. 
Coordinating Outbreak Responses and Investigations, 3. Information Sharing and Data 
Collection, 4. Communication, 5. National Uniform Standards, and 6.  Laboratory Operations and 
Coordination. 
12. Speech by Joseph Levitt, Director of the FDA Center for Food Safety and Applied Nutrition 
at the 50-State meeting, Meeting Challenges Together, Kansas City, Missouri, September 15-
17, 1998. 
13. The type of food contract we focus on in this report is the food sanitation contract. 
14.  These are inspections conducted under FDAs 03 project category for Foodborne Biological 
Hazards. 
15. These programs derive their authority from the Public Health Service Act [42 U.S.C. 201 et 
seq.], whereby FDAs role is to provide assistance and guidance to States. 
16. Based on information collected through our site visit, Texas conducted the following 
inspections under its contract and partnership agreements: 353 inspections under contract, 83 
low-acid and acidified food inspections under partnership agreement, and 107 seafood HACCP 
inspections under Seafood HACCP partnership agreement.  During this same time period, FDA 
reported that it conducted about 50 general food inspections, 13 acidified and low-acid canned 
food inspections, and 41 Seafood HACCP inspections. 
17. The following examples illustrate the shift from low-risk to high-risk food firm inspections 
under contract:  Fishery/seafood inspections conducted by the States increased by 178 percent 
over the past decade (from 269 in 1989 to 749 in 1998).  During this same time period,  soft drink 
and water inspections, which are considered low-risk, decreased by 37 percent (from 478 in 1989 
to 299 in 1998); and bakery inspections, also considered low-risk, have decreased by 14 percent 
(from 943 in 1989  to 813 in 1998). 
18.  Twenty-one of the 37 partnership agreements are for Seafood HACCP inspections; 5 are for 
low-acid canned and acidified foods; and 2 are for cheese and dairy products.  The remaining 
partnerships cover various general food categories. 
19. Between 1989 and 1998, the number of inspections that States conducted under contract 
dropped from 7507 in 1989 to 4155 in 1998. 
20. In 1998, FDA conducted 1,795 domestic food safety inspections (PAC 03803) ; the States 
conducted 1653 under partnership agreement. 
97 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX N 
21. We use the term inspector to denote all FDA personnel carrying out food firm inspections. 
22.  For contracted inspections, the States are required to use FDAs inspection classifications. 
By contrast, for inspections conducted under partnership agreement, the States can use their own 
classification systems. 
23.  FDAs consumer safety officers must have a college degree that includes 30 semester hours 
in one or a combination of subjects: biological sciences, chemistry, pharmacy, physical sciences, 
food technologies, nutrition, medical sciences, or vetrinary medicine.  These 30 hours may include 
up to 8 semester hours of statistics or coursework in computers.  A combination of education and 
experience may be substituted for the college degree; however, FDA requires that its consumer 
safety officers have 30 semester hours of science. 
24. At present, States generally inspect domestic food firms and domestic products under 
partnership agreements.  The President of the Association of Food and Drug Officials recently 
called upon FDA to enhance its coverage of imported products through expanding the 
partnerships. Article by Allison Wright,  FDAs proposed international food safety activities 
should involve partnerships with the States, Food Chemical News, 8 November 1999, p.4. 
25. While the number of inspections under State contract also declined during this time period, 
the percent of audits relative to the total number of contract inspections dropped by almost one-
third.  In 1993, FDA audited about 3.4 percent of total inspections conducted under contracts.  In 
1998, FDA audited only 2.4 percent of the total contract inspections. 
26. The Field Management Directive No. 76 calls for 6 audits for contracts with up to 100 
inspections, 10 audits for contracts with 101-300 inspections, 22 audits for contracts with 301-
900 inspections, and 34 audits for contracts with over 901 inspections.  According to the 
directive, The required number of independent audits will be accomplished for a minimum of one 
year.  If no significant performance problems are found during this period, and the overall 
performance is considered satisfactory by the District, the number of audits may be reduced by 50 
percent to a maintenance level. 
27. Those 7 district offices oversee 11 of the 38 States under contract. 
28. Several district offices cited difficulties in meeting even the 30-day time frame. 
29.  In accordance with the Paperwork Reduction Act [P.L. 104-13], FDA cannot survey more 
than 10 entities without clearance from the Office of Management and Budget.  The Federal 
Advisory Commission Act set forth the rules under which FDA can rely on information gleaned 
from external sources. 
30. We are referring to the 03 project category for Foodborne Biological Hazards. 
98 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX N 
31. The Office of Regulatory Affairs Partnership Agreement Guidance Document identifies FDA 
and State responsibilities to conduct joint inspections, but does not define their function.  The 
Model Seafood HACCP partnership agreement offers some definition, but lacks specific guidance, 
joint inspections will serve training, technology and information exchange, and verification 
functions. 
32. We note that performance audits have been conducted of the retail side of the partnership. 
However, our study focuses on inspections in the manufacturing and processing arena. 
33. In our analysis of five low-acid canned food partnership agreements, we identified 
expectations ranging from the  prompt exchange of enforcement documentation to lack of any 
specifications. 
34. The State contract semi-annual evaluation form can be found in the Field Management 
Directive No. 76, (October 24, 1995), p. 6; the partnership agreement annual evaluation form can 
be found in the Office of Regulatory Affairs Partnership Agreement Guidance Document (January 
23, 1996), Attachment C. 
35. FDAs general information telephone hotline is 1-888-FDA-INFO.  Its websites are located at 
www.foodsafety.gov and www.fda.gov. 
36. Note that this is a result of funds provided  through the Presidents Food Safety Initiative to 
support the 1995 Seafood HACCP Regulations.  While the overall number of operational FTEs 
has increased, the increases occurred primarily in the areas of Domestic Fish and Fishery Products 
and Import Seafood Products.  Over the past decade, a number of other program areas lost FTEs. 
The most notable of these were Domestic Food Safety and Domestic Acidified and Low-Acid 
Canned Foods. 
37. United States Environmental Protection Agency, United States Department of Health and 
Human Services, and United States Department of Agriculture, Food Safety From Farm to 
Table: A National Food Safety Initiative, (Report to the President, May 1997), p. 37.  The report 
cites significant decreases in FDAs inspectional coverage since 1981.  An FDA regulated plant is 
inspected by FDA, on average, only once every 10 years. 
38. Annual Partnership Evaluation of the Oklahoma Partnership Agreement, SW Region/Dallas 
District, Section 9, November 1998, Capturing partnership inspection data into the FDA Facility 
Inspection System has proved to be a problem.  Inspections performed under State contract were 
conducted using FDA forms and cover sheets, which captured all the data elements required for 
entry into the agencys electronic data inspection system.  Since inspections under the partnership 
are not being paid for and the State is receiving little monetary support from FDA for the project, 
we are not in a position to require the State to provide specific information in a specific format. 
The State uses its own inspection form to capture data elements that match its data needs. 
99 
FDA Oversight: A Call for Greater Accountability  OEI-01-98-00400  APPENDIX N 
Translation of their data for use in FDAs electronic system has resulted in some errors in the data 
capture in FDAs FIS.  We are attempting to work through this problem with more the recent 
data, but it requires some time-consuming manual manipulation of the information supplied by 
Oklahoma State Department of Health. 
39. For example, under the Oklahoma Food Safety Partnership Agreement, the Oklahoma State 
Department of Health conducts 100 percent of the food firm inspections in its State.  In the Texas 
Low Acid Canned Food and Acidified Food partnership agreement, the Texas Department of 
Health conducts 90 percent of the acidified canned food inspections, and FDA conducts 10 
percent. 
40. In some of its agreements FDA has recognized the importance of retaining a minimum level of 
inspections to maintain its own expertise.  The Model Seafood HACCP Partnership Agreement 
states, FDA will conduct at least (enter the appropriate number of inspections that are to be 
performed by FDA under the terms of the agreement, but in no case less than 10 percent of the 
fish and fishery processors in the State).  The model Seafood HACCP partnership agreement 
cites reasons for maintenance of FDA inspectional capacity as the potential for reduced State 
capacity or problems that arise with the agreement, maintaining domestic and international 
credibility through some FDA inspectional presence in each State, and maintaining intelligence 
about the industry throughout the country.  The California Low Acid Canned Food partnership 
states, FDA may make periodic LACF inspections so that FDA investigators can maintain their 
expertise in the areas of LACF and acidified food inspections. 
41. Department of Health and Human Services, Office of Inspector General, FDA Food Safety 
Inspection, OEI-05-90-01070, 1991. 
42. The Canadian Food Inspection Agency,Equivalence of the Fish and Fishery Products 
Inspection and Control Systems, Report of an Audit of the Inspection and Control System for 
Fish and Fishery Products of the U.S. Food and Drug Administration, (June 2, 1999). 
43. Institute of Medicine, National Research Council, Ensuring Safe Food from Production to 
Consumption (Washington: National Academy Press, 1998), p.7. 
44. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, CFSAN 
2000 Program Priorities, 10 February 2000. 
45. FDA has developed a cost estimate of $425,000 for fiscal year 2000 audit activity based on an 
audit frequency at 5 percent of 5,200 State contract inspections.  The FDA estimates $630,000 
for fiscal year 2001 with a frequency of 7 percent, and $988,000 for fiscal year 2002 with a 
frequency of 10 percent. 
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46. The model contract calls for States to report a considerable amount of information using 
standardized formats and FDA codes.  This includes specific information that enables FDA to 
assess a firms compliance with FDA regulations, which States themselves might not obtain 
through their own inspections.  In addition, the contract states that the inspection reports should 
detail the conditions found with sufficient narrative to enable an assessment of any objectionable 
conditions or practices found.  Where microbiologically oriented inspections are conducted, a 
more detailed description of the manufacturing process, routes of contamination, etc., will also be 
made.  Under partnership agreements, as we have demonstrated, FDA obtains information far 
below its own standards for contracts. 
47. The fourth essential feature of an ideal federal food safety system is that it be organized to be 
responsive to and work in true partnership with non-federal partners.  These include state and 
local governments, the food industry, and consumers. Institute of Medicine, National Research 
Council, Ensuring Safe Food from Production to Consumption, (Washington: National Academy 
Press, 1998), p.7. 
48. At present, the contract document devotes only one sentence to feedback: Results of the 
quality assurance review will be furnished to the contractor.  The partnership agreements 
promote more joint work and communication. 
49. In objective 6 of its Draft Preliminary Food Safety Strategic Plan, the Presidents Council on 
Food Safety calls for FDA to promote voluntary best practices developed and implemented by 
industry and/or State governments.  Presidents Council on Food Safety, Draft Preliminary Food 
Safety Strategic Plan for Public Review, January 2000. 
50. The ORA Division of Human Resource Development (DHRD) is developing a training course 
for FDA Investigators on the process and techniques for auditing State contracts and 
partnerships.  The course is planned to be offered in September 2000. 
51. In objective 5 of its Draft Preliminary Food Safety Strategic Plan, the Presidents Council on 
Food Safety calls for FDA to protect the food supply through developing additional national 
training and job standards.  Such a program could include a credentialing system for food safety 
inspectors, investigators, and program reviewers.  Presidents Council on Food Safety, Draft 
Preliminary Food Safety Strategic Plan for Public Review, January 2000. 
52. Department of Health and Human Services, Office of Inspector General, FDA Food Safety 
Inspection, (OEI-05-90-01070), 1991. 
53. Department of Health and Human Services, Office of Inspector General, FDA Food Safety 
Inspection, (OEI-05-90-01070), 1991. 
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54. FDAs Recommended National Retail Food Regulatory Program Standards (February 6, 
1998) proposes a listing program of State retail programs that meet FDA standards. 
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