Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
RETAIL FOOD SAFETY 
JANET REHNQUIST 
Inspector General 
SEPTEMBER 2001 
OEI-05-00-00540  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG) mandated by Public Law 95-452, as 
amended by Public Law 100-504, 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 Chicago office prepared this report under the direction of William C. Moran, Regional 
Inspector General and Natalie Coen, Deputy Regional Inspector General. Principal OEI staff 
included: 
Region  Headquarters 
Joe Penkrot, Project Leader  Joe Rutherford, Program Specialist

Erin Guay, Program Analyst

Tricia Fields, Program Analyst

To obtain copies of this report, please call the Chicago Regional Office at (312) 353-4124. 
Reports are also available on the World Wide Web at our home page address: 
http://www.hhs.gov/oig/oei/  E X E C U T I V E   S U M M A R Y  
PURPOSE 
This study assesses the Food and Drug Administrations (FDA) role in States adoption 
and implementation of the model Food Code and the voluntary Recommended National 
Retail Food Regulatory Program Standards. 
BACKGROUND 
Foodborne illness is a major cause of personal distress, preventable death, and avoidable 
economic burden. Every year, millions of Americans become sick and many die from 
foodborne illness, and as a result, the public has become increasingly aware and 
concerned about the safety of the food they eat. The annual cost of foodborne illness in 
terms of pain and suffering, reduced productivity, and medical costs is estimated to be in 
the billions of dollars. 
The breadth of the retail food industry makes it an impossible task for FDA alone to 
monitor the safety of food at the retail level. As a result, State and local governments 
play a critical role in overseeing the safety of the nations food supply. The FDA relies 
on more than 3,000 State and local jurisdictions to monitor retail establishments and their 
employees. State and local regulators conduct the vast majority of inspections for retail 
establishments in accordance with their own laws and authorities. In addition to many 
other types of food establishments that directly serve consumers, restaurants, 
supermarkets, and institutional food services fall under FDAs retail food protection 
program, a cooperative Federal-State food safety effort. 
The FDA has several retail food safety initiatives underway aimed at reducing the risk 
factors that cause foodborne illnesses and in achieving uniformity in retail food 
inspections. One effort involves issuing a model Food Code every 2 years to enhance the 
consistency among Federal, State, and local jurisdictions, and to improve the 
effectiveness of retail food safety programs. The Food Code provides the most current 
scientific principles in conducting retail food safety inspections. Thirty States and 
1 territory have voluntarily adopted a version of the Food Code, and another 15 States 
and 1 territory are in the process of adopting the Food Code. States and local 
jurisdictions may adopt particular aspects of the Food Code or use measures they deem at 
least equivalent to inspection techniques or procedures outlined in the Food Code. 
A second effort began in 1998 when FDA drafted voluntary Recommended National 
Retail Food Regulatory Program Standards (or the Standards) to serve as a national 
foundation for comprehensive retail food inspection regulatory programs and to guide the 
development and management of retail food inspection programs. In 1999-2000, FDA 
i
FDA & RETAIL FOOD   OEI-05-00-00540  pilot tested the Standards in 4 States and 3 local jurisdictions. Over 100 agencies 
volunteered to participate in the next phase-in cycle. The FDA believes that use of the 
Standards will be a primary focus of their dealings with retail food inspection agencies in 
the future. 
The FDA considers States adoption and implementation of the Food Code and the 
Standards as the essential elements in achieving uniformity across all jurisdictions 
responsible for retail food safety and reducing the incidence of foodborne illness. To 
determine FDAs role in assisting State and local retail food inspection agencies reach 
these goals, we conducted an electronic survey of all State retail food inspection agencies 
and met with State and local retail food inspection agencies in 10 States. In addition, we 
interviewed FDAs Regional Food Specialists as well as all members of the headquarters 
Retail Food and Interstate Travel Team. We also conducted interviews with consumer 
advocates and members of the Executive Board for the Conference for Food Protection, 
where Food Code revisions are recommended every 2 years. 
FINDINGS 
OVERALL - Respondents rate FDA highly in their promotion and support of the 
Food Code and the voluntary Recommended National Retail Food Regulatory 
Program Standards 
Overwhelmingly, respondents agreed that FDA has demonstrated their support for the 
Food Code and the Standards. Almost all respondents said that FDA encourages 
adoption of the Food Code, and described a variety of ways FDA supports this activity. 
FOOD CODE - States face multiple barriers in adopting and implementing the 
Food Code 
Nearly three-fourths of the States report that the biennial revisions to the Food Code act 
as a drawback to adopting the most recent Food Code.  Respondents also indicate other 
drawbacks, including the feasibility of some of the provisions, the cost and time involved 
in adopting or implementing an updated version of the Food Code, and the need to rely 
on FDA to interpret Food Code provisions and provide other support. 
STANDARDS - The FDA staff and State and local agency opinions differ on the 
most difficult standards to accept and implement, which may affect the way the 
Standards are implemented 
While FDA regional and headquarters staff believe that retail inspection agencies will 
encounter more difficulty with the program standards dealing with a uniform inspection 
program and compliance and enforcement, State surveys point to problems with the 
standards relating to program assessment and program resources. State and local 
ii
FDA & RETAIL FOOD   OEI-05-00-00540  agencies we visited cite standards for a trained regulatory staff and an inspection program 
based on the principles of hazard analysis at critical control points. 
OPPORTUNITIES FOR FACILITATING IMPLEMENTATION 
Develop a strategic plan outlining current and anticipated acceptance of the 
Standards by State and local agencies and detailing how FDA will respond to the 
needs of these agencies 
The retail food industry, State and local agencies, and Federal respondents, all embrace 
the Food Code and the Standards as blueprints for developing retail food inspection 
practices and organizations for the future. However, respondents at every level expressed 
concern about implementation issues, particularly in regards to a lack of resources 
necessary to carry out many aspects of the Standards. Because resources are limited at 
all levels, collaboration among FDA, State and local agencies, and the retail food 
industry is essential. What FDA needs now is to develop strategic plans to map out 
future actions, both internally as well as for the States, and we offer numerous 
suggestions that we hope will be helpful in developing such strategic plans. Our 
suggestions include that FDA: 
<	 re-evaluate the frequency of revising the Food Code and consider making the 
Food Code a requirement by publishing the model Food Code in the Federal 
Register. 
<	 issue a user guide concurrent with the issuance of a new Food Code making the 
Food Code more practical. 
<  widely publicize the availability of web-based training. 
<	 provide training to FDA staff in order for them to assist State and local agencies 
with program assessments. 
Numerous other suggestions are included in the body of the report. 
Develop a model strategic plan for the States to use as they consider acceptance 
and begin implementation of the Standards 
In addition to the strategic plan described above that outlines activities for FDAs 
consideration as they begin to roll out the Standards on a national basis, it is also 
important that FDA provide States with a model strategic plan outlining what the States 
should consider in regard to accepting and implementing the Standards. 
AGENCY COMMENTS 
The Food and Drug Administration agrees with the recommendations in this report and 
will develop strategic plans and continue to work with other groups, States and localities 
regarding innovative ways to facilitate food safety through adoption and implementation 
of the Food Code and the Standards. 
iii
FDA & RETAIL FOOD   OEI-05-00-00540  T A B L E   O F   C O N T E N T S  
EXECUTIVE SUMMARY ...................................................... i

INTRODUCTION ............................................................. 1

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

FDA Support  ............................................................... 8

Barriers to Implementing Food Code ............................................ 11

Differences on Problems with Standards  ......................................... 12

OPPORTUNITIES FOR FACILITATING IMPLEMENTATION ..................... 15

AGENCY COMMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

APPENDIX

A: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   22

iv
FDA & RETAIL FOOD   OEI-05-00-00540  I N T R O D U C T I O N  
PURPOSE 
This study assesses the Food and Drug Administrations (FDA) role in States adoption 
and implementation of the model Food Code and the voluntary Recommended National 
Retail Food Regulatory Program Standards. 
BACKGROUND 
Foodborne illness is a major cause of personal distress, preventable death, and avoidable 
economic burden. Every year, millions of Americans become sick and many die from 
foodborne illness, and as a result, the public has become increasingly aware and 
concerned about the safety of the food they eat. The annual cost of foodborne illness in 
terms of pain and suffering, reduced productivity, and medical costs is estimated to be in 
the billions of dollars. 
Although numerous Federal agencies are involved both directly and indirectly in the food 
safety system, FDA has overall Federal responsibility for all domestic and imported 
foods that are marketed in interstate commerce with the exception of meat and poultry 
products which fall under the jurisdiction of the Food Safety and Inspection Service 
within the United States Department of Agriculture (USDA). Both FDA and USDA, 
Food Safety and Inspection Service share responsibility for eggs. The Federal Food Drug 
and Cosmetic Act of 19381 established FDAs primary role in food safety as one of 
inspecting the conditions under which food is manufactured, processed, packaged, and 
stored. In addition to these inspection responsibilities, FDA assists State and local 
governments in the development and enforcement of food safety regulations as mandated 
under the Public Health Service Act.2 
The breadth of the retail food industry makes it an impossible task for FDA alone to 
monitor the safety of food at the retail level. As a result, State and local governments 
play a critical role in overseeing the safety of the nations food supply. The FDA relies 
on more than 3,000 State and local jurisdictions to monitor retail establishments and their 
employees. In addition to many other types of food establishments that directly serve 
consumers, restaurants, supermarkets, and institutional food services fall under FDAs 
retail food protection program, a cooperative Federal-State food safety effort. For 
1 21 USC 301 
2 42 USC 243 
1
FDA & RETAIL FOOD   OEI-05-00-00540  simplicity, this report uses the term retail food establishments to cover the entire range 
of facilities that fall under this cooperative program. State and local regulators conduct 
the vast majority of inspections of retail food establishments in accordance with their 
own laws and authorities. 
The FDAs Role in Ensuring Retail Food Safety 
Two FDA components work toward achieving national uniformity in retail food safety 
programs. The Center for Food Safety and Applied Nutritions mission is to promote and 
protect the public health by ensuring that food is safe, nutritious, and wholesome. The 
Office of Regulatory Affairs is responsible for all FDA field activities. Both the Center 
for Food Safety and Applied Nutrition and the Office of Regulatory Affairs work with 
State and local health departments, as well as other Federal agencies, to help resolve food 
safety concerns and conduct training to improve consistency in science-based retail food 
safety inspections. 
The FDA has several retail food safety initiatives underway aimed at reducing the risk 
factors that cause foodborne illnesses and in achieving uniform and science-based retail 
food inspections. One effort involves issuing a model Food Code every 2 years to 
enhance the consistency among Federal, State, and local jurisdictions, and to improve the 
effectiveness of retail food safety programs. The Food Code sets forth model regulatory 
requirements based on the most current scientific principles in conducting retail food 
safety inspections. Thirty States and 1 territory have voluntarily adopted a version of the 
Food Code, and another 15 States and 1 territory are in the process of adopting the Food 
Code. States and local jurisdictions may adopt particular aspects of the Food Code or use 
measures they deem at least equivalent to inspection techniques or procedures outlined in 
the Food Code. 
A second effort began in 1998 when FDA drafted voluntary Recommended National 
Retail Food Regulatory Program Standards (or the Standards) to serve as a national 
foundation for comprehensive retail food inspection regulatory programs and to guide the 
development and management of retail food inspection programs. In 1999-2000, FDA 
pilot tested the Standards in 4 States and 3 local jurisdictions. Over 100 agencies 
volunteered to participate in the next phase-in cycle. The FDA believes that the 
Standards will be a primary focus of their dealings with retail food inspection agencies in 
the future. 
Other efforts involve the Center for Food Safety and Applied Nutrition and the Office of 
Regulatory Affairs formation of a Retail Food Program Steering Committee to provide 
national leadership, enhance communication, and promote uniformity. The Steering 
Committee represents all FDA components involved in retail food safety. In addition, 
FDA established a National Retail Food Team to help improve the retail food safety 
system. The National Retail Food Team is comprised of all FDA regional food 
specialists, and headquarters retail food safety staff from the Office of Regulatory Affairs 
2
FDA & RETAIL FOOD   OEI-05-00-00540  and the Center for Food Safety and Applied Nutrition, which includes the Retail Food 
and Interstate Travel Team staff. 
The FDA and the Department of Agriculture collaborate with the Centers for Disease 
Control and Prevention on FoodNet3 and PulseNet.4  FoodNet provides a way to respond 
to new and emerging foodborne diseases of national importance, monitor the prevalence 
of foodborne diseases, and identify the sources of specific foodborne diseases. State and 
local public health laboratories participating in PulseNet perform DNA fingerprinting 
on bacteria that may be foodborne and submit the patterns to the central electronic 
database at the Centers for Disease Control for rapid comparison. 
Model Food Code 
The Food Code represents the most comprehensive source of safe food practices and 
guidelines at the retail level and has been considered the cornerstone to achieving 
national uniformity. It serves as a reference document for regulatory agencies who have 
responsibility for overseeing food safety in retail outlets such as grocery stores and 
restaurants, as well as institutions like schools, hospitals, nursing homes, prisons, and day 
care centers. Although not federally required to do so, all levels of government may 
voluntarily adopt the Food Code. 
The Food Code has evolved since the 1934 proposed Restaurant Sanitation Regulations. 
Prior to 1993, the recommended regulatory codes addressed separate entities of the retail 
food industry. Beginning in 1993, these codes were combined into a single document 
called the Food Code. The Conference for Food Protection, comprised of Federal, State 
and local agencies, the food service, retail food, and food vending industries, consumers, 
and academia, makes recommendations related to the Food Code to reflect the most 
current scientific knowledge during its biennial meeting. The FDA decides which 
Conference for Food Protection recommended changes to make to the Food Code and 
accepts those recommendations in harmony with scientific evidence, public health 
principles, and Federal regulations, directives, and policy. 
State and local retail food inspection agencies, as well as tribal agencies and Federal 
Government agencies, may use the Food Code as a model to help develop or update their 
own food safety rules and regulations. Agencies can modify the Food Code to 
accommodate their existing laws, procedures, and policies. They can adopt the Food 
3  The FoodNet project sites are California, Colorado, Connecticut, Georgia, New York, Maryland, 
Minnesota, Oregon, and Tennessee. 
4  PulseNet participants include public health laboratories in California, Colorado, Georgia, Florida, 
Hawaii, Illinois, Indiana, Iowa, Kansas, Los Angeles County, Massachusetts, Minnesota, New Hampshire, New 
Jersey, New York, New York City, Ohio, Oregon, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin. 
The laboratories at the United States Department of Agriculture, Food Safety and Inspection Service and the Food 
and Drug Administration, Center for Food Safety and Applied Nutrition are also involved in the PulseNet network. 
3
FDA & RETAIL FOOD   OEI-05-00-00540  Code either in its entirety, or section by section, using one of the following three 
methods: 
<  enacting the Food Code into statute, 
<  promulgating the Food Code as a regulation,5 or 
<	 adopting the Food Code as an ordinance (if a local legislative body is delegated 
rule-making authority or regulatory powers). 
State and local adoption of the Food Code is one of the primary approaches to achieving 
uniformity among jurisdictions, which the retail food industry strongly supports. 
However, some States, like Texas and Illinois, honor home-rule for municipal 
governments, making retail food safety inspection standardization more difficult to attain, 
and some States have a combination of home-rule and State-preempted jurisdictions. In 
such States, home-rule local municipalities make decisions about food safety regulations, 
developing and enforcing their own food safety laws, independent of State government. 
These local laws cannot be less stringent than State laws, but can be more strict. 
Besides FDAs efforts, the 1997 National Food Safety Initiative6 emphasized adoption 
and implementation of the Food Code to achieve coordination and better integration 
between the activities of the Federal, State, tribal, and local food safety agencies. In June 
of 1998, the Secretary of Health and Human Services and the Secretary of Agriculture 
jointly wrote to all State governors asking them to encourage their State agencies with 
retail food safety responsibilities to adopt the Food Code. 
Voluntary Recommended National Retail Food Regulatory Program Standards 
Although adoption of the Food Code has historically been the cornerstone in achieving 
uniformity among the various jurisdictions responsible for retail food safety, FDA 
believes that an agreed upon national standard or foundation for regulatory programs is 
an essential component of a comprehensive retail food safety system. In 1998, FDA 
formulated the Standards to assist regulatory retail food program managers in the design 
and management of a retail food program and provide a means of recognition for those 
programs that meet the Standards. Major stakeholders, including State and local 
regulatory officials as well as representatives from industry, trade associations, 
professional organizations, academia, and consumer organizations contributed to the 
development of the Standards. 
5  Some States allow adoption of the Food Code by reference, a simple published statement advising that 
certified copies of the proposed code are available for public review. Generally, this process obviates the need for 
an agencys authority to be revisited by a legislative body when the Food Code is revised. 
6  This initiative produced interagency collaboration on food safety among the Department of Health and 
Human Services, the Department of Agriculture, and the Environmental Protection Agency, culminating in the 
report entitled Food Safety From Farm to Table: A National Food Safety Initiative. 
4
FDA & RETAIL FOOD   OEI-05-00-00540  The Standards represent the basic components of a retail inspection program: regulatory 
foundation, a trained regulatory staff, an inspection program based on hazard analysis at 
critical control points principles (known as HACCP), a uniform inspection program, 
foodborne illness investigation and response, compliance and enforcement measures, 
industry and community relations (previously called industry recognition), program 
support and resources, and program assessment. The FDAs Retail Food and Interstate 
Travel Team, along with other Center for Food Safety and Applied Nutrition staff and the 
Regional Food Specialists, provide Food Code interpretations for a uniform and 
reasonable application of these Standards. The Standards were developed to meet the 
following objectives: 
<	 Promote uniformity within, and provide a foundation for, the implementation of 
regulatory retail food programs, focused on the reduction of risk factors known to 
cause foodborne illness, and the Food Codes key interventions. 
<	 Promote, through management of a regulatory retail food program, industrys 
active managerial control of foodborne illness risk factors within retail food 
establishments. 
<  Serve as a benchmark in the design and management of retail food programs. 
<  Provide a means of recognition for regulatory retail food programs that meet these 
Standards.7 
Early tests of the Standards have encouraged extensive expansion by FDA. Seven State 
and local regulatory programs participated in an FDA-sponsored pilot test designed to 
have the programs evaluate their ability to meet the Standards, the usefulness of the 
Standards in the self-assessment process, and the usefulness of the forms included in the 
Standards and provided as tools to the pilot agencies. Based in part on the pilot agencies 
positive responses to the Standards, FDAs plans include approximately 130 additional 
jurisdictions phasing in the use of the Standards in calendar year 2001. In the future, 
FDA envisions that the Standards will be part of the Food Code, incorporated as a 
separate annex. 
Other Studies 
The Office of Inspector General conducted two previous inspections on food safety. The 
first, FDA Food Safety Inspection, (OEI-05-90-01070) examined FDAs domestic food 
safety inspections and raised concerns about FDAs oversight of low-risk food firms. 
The second, FDA Oversight of State Food Firm Inspections: A Call for Greater 
Accountability, (OEI-01-98-00400) assessed FDAs oversight of food firm inspections 
conducted by States through contracts and partnership agreements. This inspection found 
that FDAs oversight of these State food firm inspections is limited, particularly for 
partnership agreements, and that FDA faces a number of barriers that hinder its ability to 
oversee States performances. 
7 Conference for Food Protection Accreditation Study Committee, 2000 Conference Report. 
5
FDA & RETAIL FOOD   OEI-05-00-00540  The General Accounting Office has issued reports dealing with a variety of issues 
regarding food safety. The General Accounting Office examined food safety in schools 
and FDA expenditures for food safety inspections. Currently, the General Accounting 
Office is in the process of conducting a survey of all State agencies responsible for food 
safety activities, focusing on States resources expended for activities related to food 
safety. 
SCOPE AND METHODOLOGY 
We interviewed State and local agency management and inspectors with retail food

safety responsibilities, FDA Regional Food Specialists, FDA headquarters staff in the

Regional Food and Interstate Travel Team, members of the Conference for Food

Protection Executive Board, and consumer advocates to gain information about the

systems and processes associated with the adoption and implementation of the Food

Code and the Standards. We did not attempt to measure any States effectiveness in

using the Food Code or the Standards. We did not examine the Food Code or the

Standards for adequacy as they relate to retail food safety.

Throughout the inspection process, we systematically gathered both quantitative and

qualitative data from the different stakeholder groups to identify issues and learn their

perceptions of the systems and processes associated with the tools FDA uses to assist

State retail food inspection agencies. We conducted extensive pre-inspection work to

gain background knowledge and learn about pertinent issues in retail food safety.

During pre-inspection, we met with officials at FDA headquarters. We also attended

FDA regional-sponsored retail food safety seminars as well as a meeting of the National

Retail Food Team. We met with Office of Inspector General legal staff to discuss FDA

relations with the retail food industry. We conducted on-site visits of three local and one

State food safety inspection agencies. We met with four food safety experts at Kansas

State University, and two team members attended a food safety course sponsored by the

National Restaurant Association. We also interviewed representatives from seven

industry and association groups, two consumer advocacy organizations involved with

retail food safety issues, and the Joint Commission on Accreditation of Health

Organizations, which inspects some institutional food services as part of its accreditation

process. 

We used four methods for collecting data in this evaluation. First, we conducted an

electronic survey of all 66 State agencies with retail food safety responsibilities. The

survey contained both open and closed ended questions about adopting the 

1999 Food Code changes, overcoming barriers to Food Code adoption and/or

implementation, and FDAs role in the process of adopting and implementing the Food

Code. We asked similar questions regarding accepting and implementing the Standards. 

We also asked about improvements that need to be made to these processes with specific

6
FDA & RETAIL FOOD   OEI-05-00-00540  emphasis on FDAs role in assisting State and local agencies to adopt and implement the 
Food Code and the Standards. Sixty-one State agencies completed these surveys, for a 
92 percent response rate. 
Second, we conducted on-site interviews with State and local retail food inspection 
agencies and consumer advocates involved with retail food safety issues. With all of our 
on-site and telephone interviews, we used a structured discussion guide to elicit 
information about FDAs role in the Food Code adoption process, and their views of the 
process of implementing the Food Code and the Standards. We also gathered 
information about improvements that they believe need to be made to the process and 
system in which they operate. We visited State and local agencies in 10 States and spoke 
with three consumer advocates. 
State retail food inspection agency officials included program directors, program 
managers, and inspectors from a purposive sample in Arizona, California, Georgia, 
Michigan, Minnesota, Rhode Island, South Carolina, Texas, Vermont, and Wyoming. 
We selected these States following discussions with FDA staff and other experts and 
based on criteria such as geographic variability, size, differing levels of State and local 
involvement in retail food inspections, and status of Food Code adoption. 
We conducted the site visits with these States during February and March 2001 to collect 
more in-depth information about the Food Code, the Standards, and the role of FDA. 
When applicable, we also met with local retail food safety agencies and consumer 
advocates to get their perceptions of the Food Code, the Standards, and FDAs role in the 
process of adopting and implementing the Food Code. Overall, we met with 13 State 
retail food inspection agencies, 11 State inspectors, 16 local retail food inspection 
agencies, and 11 local inspectors. 
Third, we interviewed all 21 FDA Regional Food Specialists as well as all 6 members of 
the Retail Food and Interstate Travel Team. We conducted the interviews either in 
person or by telephone. 
Finally, we conducted structured personal or telephone interviews with 18 of the 
22 members of the Executive Board for the Conference for Food Protection for years 
2000 - 2002.  The Executive Board members represent the perspectives of Federal 
agencies, State and local regulatory bodies, industry, academia, and consumers. We 
spoke to three other Executive Board members during our pre-inspection or on-site 
activities. One member did not respond to our requests to speak on these issues. 
We conducted our review in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
7
FDA & RETAIL FOOD   OEI-05-00-00540  F I N D I N G S
OVERALL - Respondents rate FDA highly in their promotion
and support of the Food Code and the voluntary
Recommended National Retail Food Regulatory Program
Standards
Supporting the Food Code
Overwhelmingly, respondents agreed that FDA has demonstrated its support for the Food
Code.  Eighty-five of 86 respondents said that FDA encourages adoption of the Food
Code and described a variety of ways FDA supports this activity.  Respondents cited
FDAs training and their efforts to standardize inspectors8 as well as the willingness
and availability of FDAs Regional Food Specialists and headquarters staff to assist them
throughout the phases of Food Code adoption and implementation.  This assistance
included FDA staff serving on State and local task forces, testifying at hearings and
speaking at grass roots meetings, and interpreting Food Code provisions.  Overall, 
60 percent of the respondents characterized FDAs Food Code support as effective.
In our survey of State Chart 1                                           
retail food agencies, we
asked them to rate FDAs
training on the Food Code
and their interpreting of
the Food Code.  Of the 
56 State agencies
responding to these survey
questions, 62 percent rated
FDAs training as either
excellent or above
average, and 57 percent
similarly rated their Food
Code interpretation
assistance.  Chart 1 shows
these satisfaction levels.
8  Standardization is a term FDA uses to describe the approach of training State inspectors in FDA
methods.  FDA standardizes State retail food inspectors by providing intensive, one-on-one training during the
inspection process.  Standardized inspectors learn how to inspect in accordance with the latest Food Code.  They are
then expected to standardize other State and local inspectors, who likewise should standardize other inspectors.
8
FDA & RETAIL FOOD                                                                                                                                                 OEI-05-00-00540 Promoting the voluntary Recommended National Retail Food Regulatory Program
Standards
States surveyed indicated widespread knowledge and acceptance of the Standards.9 
Ninety percent of the State survey respondents said they were familiar with the
Standards.  When we shared copies of the Standards with respondents, 96 percent
believed that FDA had identified the appropriate Standards necessary for an effective
retail food safety inspection agency, and 93 percent believed that the Standards were
important to an agencys effectiveness in combating foodborne illnesses.
Our on-site visits at State and local retail food inspection agencies showed some
differences when compared to the State survey results.  During these visits, we found that
while knowledge of the Standards at the State management level was high, knowledge of
the Standards dropped for State inspectors.  Knowledge of the Standards at the local level
was lower than knowledge
at the State level.  Six of Chart 2    
the 16 local agencies10 and 
15 of 22 inspectors
(representing both State
and local agencies) visited
on-site were unfamiliar
with the Standards.
The relative newness of
the Standards may explain
why State survey
respondents believe that
FDAs communication of
the objectives and
interpretations of the
Standards has been
average at best.  Eighty-
one percent of State
agencies responding to the
survey said that FDA promotes the Standards, but most respondents could not comment
on the effectiveness of these efforts yet.  Even though FDA explained the objectives at
numerous forums, on its website, and during field sanitarian courses, Chart 2 shows that
most States do not believe that FDA has communicated the objectives or provided
Standards interpretations at an above average level.  More than half of FDA Regional
9 At the time of our data collection, Standard 7 was called Industry Recognition.  Therefore, the questions
on our survey and questions asked during our on-site visits refer to this standard prior to the recent change. 
10  Three local agencies we visited in Texas participated in the pilot project.  Those pilot agencies are very
familiar with the Standards.
9
FDA & RETAIL FOOD                                                                                                                                                 OEI-05-00-00540 Food Specialists believed it is too soon to judge FDAs performance on interpreting the
Standards.
Written and web-based support for the Food Code and voluntary Recommended
National Retail Food Regulatory Program Standards
Most respondents believed that FDA provided excellent or above average written
materials and Internet information for the Food Code and Standards.  During our on-site
visits and phone interviews, we specifically asked respondents to rate FDAs written
materials and websites as they relate to supporting the Food Code and Standards.  These
interviews included State and local retail food inspection agency heads, Executive Board
members of the Conference for Food Protection, consumer advocates, FDAs regional
Food Specialists and FDAs Retail Food and Interstate Travel Team.
Chart 3 shows that State and Chart 3           
local retail food inspection
agencies and Conference for
Food Protection Executive
Board members
overwhelmingly believe that
FDAs written materials
provide support for the Food
Code and the Standards. 
However, 6 of the 16 local
agencies are unaware of any
FDA written materials for
these initiatives.
In addition, sixteen FDA
respondents rated their written
support as excellent or above
average, four respondents
rated it as average, and two as
poor.  Two FDA respondents
said they did not know
enough to give a rating, 
two did not comment, and one did not give a rating but was favorable about the written
support that FDA provides for both the Food Code and the Standards.  Two consumer
advocates called the written support above average, while one was not aware of any FDA
written support for the Food Code or the Standards.
Similarly, respondents rated FDAs website highly for providing them support for the
Food Code and the Standards.  Again, six of the local agencies are unaware of any FDA
website information relating to these topics.
In addition to these respondents, thirteen FDA staff described their website as either
excellent or above average, three called it average, and four described it as below average
10
FDA & RETAIL FOOD                                                                                                                                                 OEI-05-00-00540 or poor. The responses of the remaining seven FDA members could not be classified into 
the aforementioned ranking categories. One consumer advocate rated it above average, 
and one was not aware of the website. 
FOOD CODE - States face multiple barriers in adopting and
implementing the Food Code 
Frequency of Food Code revisions a major barrier to State adoption 
Seventy-two percent of States surveyed reported that frequent revisions to the Food Code 
act as a drawback to adopting the most recent Food Code. Similarly, during our on-site 
visits, many respondents told us they believed the Food Code is updated too frequently. 
Sixteen of 34 States that did not update their codes to include the 1999 Food Code 
changes indicated that the length of time and the difficulty of the adoption process 
inhibits them from updating their code every 2 years. Some of these States had just 
finished adopting an earlier version of the Food Code and are working on implementation 
issues, so they did not consider adopting the 1999 Food Code. Many States report that 
they do not have the time and resources to update their retail food safety regulations 
every time the Food Code changes, especially when the new version may contain only 
minor changes from an earlier version of the code. 
Retail Food and Interstate Travel Team staff are evenly divided on the issue of Food 
Code frequency. Similarly, the Conference for Food Protection Executive Board 
members split between thinking that the Food Code revision cycle was satisfactory or too 
frequent. Local retail food inspection agencies frequently take guidance from their States 
on Food Code adoption and are not typically involved in the Food Code revision and 
adoption processes. 
Additional barriers to adopting and implementing the Food Code 
Besides the frequency of Food Code revisions, respondents also indicate other drawbacks 
including the feasibility of some of the provisions, the cost and time involved in adopting 
or implementing an updated version of the Food Code, and the need to rely on FDA to 
interpret Food Code provisions and provide other support. 
Fifty-four percent of State survey respondents specified that a major drawback to 
adopting the Food Code concerns the feasibility of some Food Code provisions. They 
also highlighted the political climate in the State, the reluctance to change their current 
retail food safety activities, and concerns about losing State control to the Federal 
Government as being additional barriers to Food Code adoption and implementation. In 
some cases, industry opposition to certain Food Code provisions inhibits changing State 
retail food laws. 
11
FDA & RETAIL FOOD   OEI-05-00-00540  All respondent groups identified the cost and time involved in adopting and 
implementing the Food Code as barriers. They explained that the adoption and 
implementation process was resource intensive, particularly in terms of the legislative 
change and associated training costs necessary to learn a new code and the corresponding 
inspection process. 
Dependency on FDA for support, and States already having more stringent laws than the 
Food Code, represent other drawbacks States face when deciding to adopt and later 
implement the Food Code. Twenty-six percent of State survey respondents reported the 
need to rely on FDA for interpreting Food Code provisions and providing other 
implementation support as an impediment to their adopting a version of the Food Code. 
Based on the State responses to the survey question, we are unsure whether States are 
concerned that FDA does not have adequate resources to respond to requests for support 
or that States do not want to rely on FDA and want to be more independent. 
The FDAs role in helping States overcome Food Code barriers 
Seventy percent of the State survey respondents and 85 percent of the on-site respondents 
report that they believe FDA can play a role in helping retail food inspection agencies 
overcome the barriers faced in adopting and implementing the Food Code. They suggest 
that FDA could help States adopt the Food Code by reducing the frequency of updates to 
the Food Code, by making the Food Code a regulation rather than a recommendation, and 
improving the format of the Food Code. All respondent groups mentioned the published 
format of the Food Code as not being user-friendly for either inspectors or retail food 
operators. 
In terms of how FDA can better help States implement the Food Code, the respondents 
suggest that FDA could devote more resources (both at the headquarters and regional 
level) to retail food safety and implementation issues, and expand the technical assistance 
and support FDA currently provides to the States. Specific suggestions relating to 
improved technical assistance include expanded training, additional educational and 
guidance materials, more timely Food Code interpretations, and marketing the 
importance of the Food Code. 
STANDARDS - The FDA staff and State and local agency
opinions differ on the most difficult standards to accept and
implement, which may affect the way the Standards are
implemented 
Although the Standards are in draft form and have not been accepted and implemented by 
most retail food agencies, we asked respondents which standards they believe would be 
the most difficult to accept and implement. Many FDA staff said that the difficulty of 
implementing the Standards would vary across States, i.e. the most difficult standard for 
12
FDA & RETAIL FOOD   OEI-05-00-00540   one State could be the easiest for another. The two standards most frequently mentioned 
for each respondent group are displayed in Chart 4. 
Chart 4 
Respondent Group  Standards Most Difficult to Accept and Implement 
State Agency Survey    Program Assessment 
  Program Resources 
State and Local Agencies    Trained Regulatory Staff 
(on-site visit respondents)    Inspection Program Based on HACCP Principles 
State and Local Retail    Uniform Inspection Program 
Food Inspectors    Compliance and Enforcement 
(on-site visit respondents) 
FDA Staff  (headquarters    Uniform Inspection Program 
and regional)    Compliance and Enforcement 
Source: OEI Data, 2001 
The first two respondent groups shown above in Chart 4 (State agency survey 
respondents and the on-site respondents from the State and local agencies) differ in terms 
of which Standards they believed would be most difficult to accept and implement. This 
difference can be attributed to the fact that we conducted on-site visits with only 10 of the 
61 agencies who responded to the survey and the people that we met with on-site may not 
have been the person to complete the survey. In addition, the responses from our on-site 
visits include input from local agencies as well as from the State agencies. 
In our survey, we asked State agency respondents to indicate whether certain factors 
represent barriers to implementing any of the Standards. Respondents who identified 
each factor as a barrier were then asked which standard would be the most difficult to 
implement because of the barrier. Chart 5 on the following page shows their responses. 
We list two standards if they were mentioned the same number of times. 
13
FDA & RETAIL FOOD   OEI-05-00-00540  Chart 5 
Percent of State agency respondents who  Standard most often cited by 
consider this factor a barrier  respondents as most difficult to 
implement because of barrier 
Lack of resources (69%)   Trained Regulatory Staff 
Feasibility (41%)   Trained Regulatory Staff 
 Inspection Program Based on 
HACCP Principles 
Lack of industry support (34%)   Inspection Program Based on 
HACCP Principles 
Lack of consistency with current State or local   Uniform Inspection Program 
laws or regulations (31%)   Compliance and Enforcement 
Need to rely on FDA for interpreting (10%)   Uniform Inspection Program 
 Compliance and Enforcement 
Source: OEI Survey, 2001 
The FDA staff identified barriers similar to those cited by State retail food inspection 
agencies, including lack of resources (time, staffing, and money), training needs, and 
legislative challenges. 
14
FDA & RETAIL FOOD   OEI-05-00-00540  O P P O R T U N I T I E S  F O R  
F A C I L I T A T I N G  I M P L E M E N T A T I O N  
The retail food industry, State and local agencies, and Federal respondents, all embrace 
the Food Code and the Standards as blueprints for developing retail food inspection 
practices and organizations for the future. However, respondents at every level expressed 
concern about implementation issues, particularly in regards to a lack of resources 
necessary to carry out many aspects of the Standards. 
We recognize that these resources may be hard to come by, but over time, real progress 
can be made to implement these measures. Because resources are limited at all levels, 
collaboration among FDA, State and local agencies, and the retail food industry is 
essential. What FDA needs now is to develop strategic plans to map out future actions, 
both internally as well as for the States, and we offer numerous suggestions that we hope 
will be helpful in developing such strategic plans. The following suggestions for FDAs 
consideration primarily focus on the Standards because of their relative newness as 
compared to the Food Code. However, we recognize that the adoption and 
implementation of the Food Code can be an integral part of each standard and should be 
considered when appropriate. We leave it to FDA to work with State and local agencies 
to determine how best to prioritize these actions. 
Develop a strategic plan outlining current and anticipated
acceptance of the Standards by State and local agencies and
detailing how FDA will respond to the needs of these
agencies 
The strategic plan could focus on both short and long-term activities related to each of the 
nine standards. The widespread acceptance of the Standards by State and local retail food 
inspection agencies, as evidenced by their volunteering in unexpectedly high numbers to 
pilot the Standards, points toward the necessity of FDA devoting significant support and 
resources to these agencies to help them achieve some or all of the Standards. The FDA 
could make State and local retail food inspection agencies aware of FDAs commitment to 
the Standards by publishing the strategic plan. The strategic plan could specify needs, 
targets, and FDA commitment for each standard. The strategic plan may also help FDA 
improve their marketing strategies to highlight the importance of participation from all 
States and local jurisdictions for achieving national uniformity and reducing the incidence 
of foodborne illness through the use of the Food Code and the Standards. 
We recognize that many standards intertwine. For example, an agency cannot have an 
effective compliance and enforcement program without a regulatory foundation or a 
trained regulatory staff. We also recognize that it is not realistic to expect that every 
agency can or will meet each of the Standards. We understand that implementing the 
15
FDA & RETAIL FOOD   OEI-05-00-00540  Standards will require considerable effort and support from both FDA and retail food 
inspection agencies. Based on these understandings and on advice from our respondents, 
we suggest that FDA consider the following proposals in developing their strategic plan. 
Standard 1 - Regulatory Foundation 
<	 Improving Adoption of the Food Code - The FDA could re-evaluate the 
frequency of revising the Food Code. Publishing Food Code updates less 
frequently than every 2 years would remove the major barrier States currently face 
in adopting recent versions of the Food Code. The FDA could also consider 
making the Food Code a requirement rather than a regulation by publishing the 
model Food Code in the Federal Register. This would facilitate adoption for States 
that have the ability to adopt Federal regulations by reference and would help 
alleviate the problem of trying to keep State regulations consistent with the latest 
version of the Food Code. Codifying the Food Code would ultimately help 
achieve national uniformity. 
<	 User Guide to Food Code - The FDA could issue a user guide concurrent with the 
issuance of a new Food Code. The user guide would make the Food Code more 
practical for inspectors and retail food operators to use on a daily basis. All 
respondent groups mentioned the published format of the Food Code as not being 
user-friendly for either inspectors or retail food operators.  Presently, the Food 
Code is written to be a regulation. Possibilities for the user guide include an 
abbreviated version of the Food Code which contains the critical items of the Code 
and consolidates all the provisions relating to one topic together in one section. 
The user guide should be smaller than the Food Code to facilitate its use in the 
field. The State of Texas publishes a Field Inspection Manual to promote 
uniformity in the application of their Food Establishment Rules. The manual 
outlines critical items and relates these items to the State inspection form. Also, 
the Association of Food and Drug Officials has published a Food Code Pocket 
Guide for Regulators that corresponds with the 1999 Food Code and includes 
critical items such as definitions, handwashing requirements, temperature 
requirements, Reduced Oxygen Packaging, and warewashing requirements. These 
could serve as examples for FDA. Other States may also have similar tools to 
assist the development of the user guide.  Since retail inspection agencies 
frequently find non-English speaking operators and employees at retail food 
establishments, FDA could also make a Food Code user guide available in 
different languages for retail food operators. 
<	 Interpretations of Food Code and Standards - The FDA could devise a 
systematic way to share Food Code and Standards interpretations to help ensure 
consistent interpretation and enforcement. Presently, FDA responds to individual 
questions posed by a retail food inspection agency, usually through the Regional 
Food Specialist. Other Regional Food Specialists and agencies are not routinely 
advised of either the questions or the answers. So, when the same issues arise 
elsewhere, the process of trying to resolve similar questions must be repeated. 
16
FDA & RETAIL FOOD   OEI-05-00-00540  Standard 2 - Trained Regulatory Staff 
<	 Need for Standardization Staff - The FDA could determine what additional staff 
both in the field and in the Retail Food and Interstate Travel Team it will need to 
perform standardizations of retail food safety inspectors. It is reasonable to 
assume that demands for standardization will increase as a result of the Standards, 
especially with local retail food safety inspection agencies participating. The FDA 
could poll the volunteering agencies in the second pilot test of the Standards to get 
an estimate of what standardization needs those agencies will now have. The 
demand for FDAs standardization of retail food safety inspectors could increase 
exponentially with both State and local agencies using the Standards. 
<	 Web-based Training - Because inspection agencies have limited training and 
travel budgets, FDA could widely publicize the availability of web-based training. 
State and local retail food inspection agencies look forward to FDAs planned 
web-based training. (In fact, many respondents requested more FDA training in 
any form.) Web-based training will allow most inspection agencies to benefit 
from this valued resource. 
<	 State and Local Training - The FDA could develop more flexibility in 
responding to State and local training needs. State and local agencies could make 
their training needs known electronically, as they determine them, rather than 
making an annual request through the Regional Food Specialist. This process 
would allow local agencies more input into the training calendar. 
<	 Recruitment Clearinghouse - The FDA could develop and maintain a national 
clearinghouse of retail food inspection vacancies. An ongoing problem retail food 
inspection agencies face is staff recruitment. College students or graduates in the 
field could post their resumes and have a central job bank to locate positions. 
State and local retail food inspection agencies could post their vacant positions. 
The clearinghouse could be developed to be dynamic, i.e., to allow agencies and 
applicants to link directly to each other, or to have the resumes and vacancies 
time-limited, so the bank of available jobs and applicants is current. 
<	 Turnover Exception - The FDA could develop an exception for the staffing 
standard for agencies with well-trained staff who suddenly confront a turnover 
problem. With high staff turnover, some retail food safety inspection agencies 
cannot meet, or continually meet, this standard if it is strictly interpreted. 
Standard 3 - Inspection Program Based on HACCP Principles 
<	 Software Inspection Tools - The FDA forms could be available to retail food 
inspection agencies in a software program compatible with hand-held computers, 
as FDA is doing with their uniform inspection software. The FDA developed a 
form for a Risk Control Plan for these retail HACCP reviews and has an inspection 
form for standardization purposes. Although some retail food inspection agencies 
17
FDA & RETAIL FOOD   OEI-05-00-00540  believe they perform retail HACCP inspections, the standard requires 
documentation in a manner consistent with HACCP principles. 
Standard 4 - Uniform Inspection Program 
<	 Model Inspection Forms - Recognizing that States and local jurisdictions may 
have to make revisions to meet their laws, FDA could develop a model inspection 
form containing a common list of elements required by this standard. Jurisdictions 
could configure the FDA-developed software to meet local requirements. 
Standard 5 - Foodborne Illness Investigation & Response 
<	 Training Outreach - The FDA could reach out to medical schools to offer 
training on foodborne illnesses and the appropriate responses as they have done in 
partnership with the American Medical Association. Several respondents pointed 
out that the medical community is not always trained to identify and report 
foodborne illnesses. The FDA could also make this training available to 
physicians via the Internet. 
<	 Model Linkages - The FDA could develop a model flow for foodborne illness 
investigation and response, clarifying what different agencies could do in certain 
situations. Communication links between agencies are sometimes difficult, with 
the State retail food inspection agency sometimes not being aware or involved 
until late in the process. 
<	 Improved Surveillance System - The FDA could continue to work with the 
Centers for Disease Control and Prevention and others to improve the surveillance 
of foodborne diseases. The FDA could help to raise States awareness about 
FoodNet so they can access the information and use FoodNets active surveillance 
system as a model in developing or improving States foodborne illness 
investigation and response systems. The FDA could also promote States 
awareness about and involvement in the PulseNet program. Expanded State 
participation in PulseNet would improve the ability to stop ongoing foodborne 
illness outbreaks. 
Standard 6 - Compliance and Enforcement 
<	 Model Programs - Following up on Food Code violations has typically been a 
weak point with many agencies. The FDA could develop model programs and/or 
highlight best practices of programs similar to their own to emulate in order to 
help retail food inspection agencies attain this standard. These examples are very 
important to localities where the program leadership and/or the political climate 
has not been conducive for an effective compliance and enforcement program. 
18
FDA & RETAIL FOOD   OEI-05-00-00540  Standard 7 - Industry and Community Relations (Previously called Industry 
Recognition) 
<	 Best Practices - The FDA could evaluate and disseminate a variety of best 
practice approaches to recognizing retail food service operators. This is 
important because many retail food inspection agencies view themselves as 
enforcement agencies. For them, the notion of commending a retail food operator 
runs counter to that impulse. 
<	 State and Local Recognition - The FDA could also prominently recognize State 
and local agencies that do an exemplary job meeting some or all of the Standards. 
Standard 8 - Program Support and Resources 
<	 Testimony - As FDA has done with Food Code adoption, it could assist State and 
local retail food safety inspection agencies by providing testimony in support of 
the Standards, especially relating to appropriate staff-to-facility ratios and the 
minimum frequencies of inspections. 
<	 Practical Advice to Agencies - The FDA could develop written materials on the 
Standards that explain the practical implications of the Standards to program 
administrators. The FDA could explain the anticipated resources and 
documentation necessary for each of the Standards so agencies and their 
employees could better understand how they will be affected. 
<	 Innovative Grants - The FDA could continue its innovative food safety grants to 
retail food inspection agencies who develop new ways to attack problems relating 
to foodborne illnesses in the retail setting and explore new funding mechanisms 
available for State and local agencies. 
<	 Minimum Equipment Needs - The FDA could define minimum program 
equipment necessary for retail food inspections as well as for compiling the data 
necessary to meet and carry out the Standards. The FDA should also work with 
agencies to help them get these necessary tools. The FDA currently lends 
substantial assistance to agencies in terms of training and interpretation of the 
Food Code and Standards. And some Regional Food Specialists have found 
creative ways to fund small, but important, purchases for retail food inspection 
agencies when no alternative local funding was possible. But many of the more 
than 3,000 retail food inspection agencies are very small - sometimes one person 
for a county - and have little equipment. For those inspectors without computers, 
on-line access to training is impractical and they may not have the inspection 
equipment to adequately perform this basic function. 
Standard 9 - Program Assessment 
<	 Assessment Training - The FDA could provide training to FDA staff in order for 
them to assist State and local agencies with their program assessments. Program 
19
FDA & RETAIL FOOD   OEI-05-00-00540  assessment has not been featured prominently in retail food inspection agency 
activity in the past. Many agencies will be looking to FDA for assistance, at least 
initially. 
<	 Audit Process - The FDA needs to develop its own audit process to determine 
whether Standards are met. 
<	 Certified Evaluation Officers - The FDA needs to develop a procedure for 
certifying Evaluation Officers, and a plan for ensuring that an adequate number of 
Certified Evaluation Officers are present in the State and local jurisdictions. This 
standard requires that an FDA-Certified Evaluation Officer conduct an outside 
program validation by using FDA validation procedures every 3 years. 
Develop a model strategic plan for the States to use as they
consider acceptance and begin implementation of the
Standards 
While the above strategic plan details activities for FDA to consider as they begin to roll 
out the Standards on a national basis, it is also important that FDA provide States with a 
model strategic plan outlining what the States should consider in regard to accepting and 
implementing the Standards. Such a document would assist the States as they make 
decisions regarding the allocation of resources and determining future actions at the State 
level in regard to retail food safety. The FDA can use some of the suggestions we made 
above for their own strategic plan as well as incorporate new information as they see fit 
into the model State plan. 
20
FDA & RETAIL FOOD   OEI-05-00-00540  A G E N C Y   C O M M E N T S  
The Food and Drug Administration agrees with the recommendations in this report and 
will develop strategic plans and continue to work with other groups, States and localities 
regarding innovative ways to facilitate food safety through adoption and implementation 
of the Code and the Standards. 
We would like to thank FDA for their assistance in conducting this study, especially for 
the availability of their staff at all levels to discuss their experiences and provide 
meaningful and insightful comments. 
21
FDA & RETAIL FOOD   OEI-05-00-00540  APPENDIX A 
Agency Comments

22
FDA & RETAIL FOOD   OEI-05-00-00540  APPENDIX A 
Agency Comments 
FDAs Comments on the Office of Inspector Generals (OIG) 
Draft Report Regarding the FDAs Retail Food Safety Program 
FDA welcomes the OIGs draft report Retail Food Safety as a fair assessment of the 
challenges FDA faces in assisting jurisdictions in their regulation of food establishments 
at the retail level. Because resources are limited at all levels, collaboration is essential 
among FDA, State and local agencies, and the retail food industry. 
As of May 16, 2001, 30 states have adopted the Food Code (Code) and 15 states are 
working on adopting the Code. We will continue to work with the states in achieving 
Code adoption. In addition, FDA has funded a contract with the Association of Food and 
Drug Officials (AFDO) to assess whether the substance of each "adoption" equals FDAs 
model Code expectations. 
FDA agrees with the recommendations in this report. Some of the recommendations can 
be implemented with current resources, but others will be implemented as resources 
become available. 
FDA will review the frequency of issuance of and codification of the Code to facilitate 
adoption by the States. We will also expand outreach to ethnic communities as resources 
become available. 
Some of the recommendations are being addressed by the many organizations with which 
we leverage, e.g., the Conference for Food Protection (CFP), AFDO, National 
Environmental Health Association (NEHA), and National Association of County and 
City Health Officials (NACCHO). The Center for Disease Control and Prevention 
(CDC) and FDA have also partnered in several projects, including the Environmental 
Health Sanitarians (EHS)-Net program in which experienced EHS are trained and 
assigned to certain agencies. Their task is to assist the agencies in expanding outbreak 
investigations to identify precursors to the occurrence of foodborne illness risk factors 
and to assist in promoting the integration of the Standards in jurisdictions' regulatory 
schemes. FDA will continue partnering with these and other groups regarding additional 
and innovative ways to facilitate food safety through adoption and implementation of the 
Code and the FDAs Recommended National Retail Food Regulatory Program 
Standards (Standards). 
23
FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400  APPENDIX A 
Agency Comments 
FDAs Response to OIG Recommendations 
OIG Recommendation:  Develop strategic plans. 
FDA Comment:  FDA agrees. The current Retail Food Steering Committees 
Operational Plan includes a specific plan for fiscal years 2002 and 2003 to promote 
implementation of the Standards, including enrollment of a certain number of states and 
localities in the Standards each year, conducting regional workshops on the Standards, 
and other targeted efforts. We will work towards developing an expanded strategic plan. 
We will also develop a model strategic plan for states. 
Standard 1  Regulatory Foundation: 
#  OIG Recommendation: Improve Adoption of the Food Code 
FDA Comment: FDA acknowledges the difficulties states have had keeping pace with the two-
year revision cycle. Under the rubric of the CFP, FDA is working with an ad-hoc committee to 
review this cycle. The ad-hoc committee is expected to report back to the CFP in April 2002. 
#  OIG Recommendation: Codify the Code: 
FDA Comment:  FDA agrees in part with this recommendation. FDA is actively engaged 
in codifying the Code for its Interstate Travel Program (ITP) by revising 21 CFR 1240 
and 1250 and inserting the Code, as it relates to interstate travel conveyances in 21 CFR 
1260. FDA anticipates completing this in 2002. The FDA is also working on codifying 
certain model Code provisions that relate to egg safety. FDA will subsequently review 
the feasibility of codifying the rest of the Code. 
#  OIG Recommendation: Issue a User Guide to the Code 
FDA Comment:  FDA agrees with the need to provide a plain-speaking guide to the 
Code. FDA will review the options to address this, including AFDO's Pocket Guide for 
Regulators or one-page compilations of key reference information for food and 
equipment (e.g., cooking times and temperatures, sanitizer concentrations, and lighting 
requirements). 
#  OIG Recommendation: Interpretations of Code and Standards 
FDA Comment:  FDA agrees and is looking into posting to a web site the responses to 
frequently asked questions, as well as responses to less frequent inquiries. 
24
FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400  APPENDIX A 
Agency Comments 
Standard 2  Trained Regulatory Staff: 
#  OIG Recommendation: Need for Standardization Staff 
FDA Comment: FDA agrees and will assess the need for additional staff to provide adequate 
standardization opportunities sought by the regulatory agencies. 
#  OIG Recommendation: Web-based Training 
FDA Comment:  FDA agrees with this recommendation. Web-based training is essential 
to leverage scarce resources and, therefore, it represents an integral part of the Agencys 
retail food safety game plan. FDA has initiated "Office of Regulatory Affairs University" 
(ORA U) which will combine face-to-face, web-based and satellite training. ORA U is 
being rolled out in the summer of 2001, with California, Colorado, and Texas serving as 
pilot participant states. The retail curriculum is consistent with Standard 2 of the 
Program Standards. The curriculum is being developed jointly with AFDO and is also 
being coordinated with a "certification" initiative by the CFP. The following web based 
courses are presently under development. These courses are expected to be available by 
spring of 2002: 
E  Public Health Principles

E  Basic Food Law 

E  Food Microbiology/Chemistry

E  Basics of Hazard Analysis and Critical Control Point (HACCP)

E  Investigating Foodborne Illness

E  Communications

E  Basics of Sanitation

E  Basics of Inspection 

These web-based courses are being developed through a Cooperative Research and

Development Agreement (CRADA) with EduNeering, a learning technology firm from

Princeton, New Jersey.  Through the CRADA, EduNeering will offer the same web

based courses to the regulated industry.

The other component of the curriculum is face-to-face courses. In conjunction with

AFDO, FDA is developing a "Basics" course to train new inspectors, as well as a higher

level "retail applications" course for more experienced inspectors. Each "course-in-a-

box" will include lesson plans, audiovisual materials, exercises, and exams. The FDA,

AFDO, other associations, or the sponsoring agency will deliver the face-to-face courses. 

Such courses will be promoting a national uniform teaching vehicle, while 

25
FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400  APPENDIX A 
Agency Comments 
simultaneously providing the opportunity for state/local agencies to include unique 
requirements/procedures of the state/local municipality in the course. These courses will 
be implemented according to available resources. 
#  OIG Recommendation: State and Local Training 
FDA Comment:  FDA agrees with this recommendation and will address it through 
ORA U. 
#  OIG Recommendation: Recruitment Clearinghouse 
FDA Comment:  FDA agrees that a national clearinghouse for retail food inspection 
vacancies is desirable. FDA will explore options for this. 
#  OIG Recommendation: Turnover Exception 
FDA Comment:  The Standards are intended as a benchmark infrastructure and operating 
framework for the norm. If needed, the mechanics for addressing temporary deviations 
in the listing program can be discussed as part of the CFP process. 
Standard 3  Inspection Program Based on HACCP Principles: 
#  OIG Recommendation: Software Inspection Tools 
FDA Comment: FDA has been exploring new hand-held computers with the memory 
capacity to store the entire Electronic Inspection System (EIS). FDA plans to develop an 
enhanced version of this system and will explore with the developer the possibility of 
including forms such as the Risk Control Plan and the Inspection Report Form that is 
used for standardization. 
#  OIG Recommendation: Model Inspection Forms 
FDA Comment:  FDA agrees and is currently working with a CFP Committee to develop 
essential elements of an inspection form. 
26
FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400  APPENDIX A 
Agency Comments 
Standard 5  Foodborne Illness Investigation & Response: 
#  OIG Recommendation: Training Outreach 
FDA Comment:  FDA agrees and, in collaboration with the American Medical 
Association, the CDC, and the United States Department of Agriculture (USDA), has 
developed an educational tool on foodborne illness for physicians, DIAGNOSIS AND 
MANAGEMENT OF FOODBORNE ILLNESS: A PRIMER FOR PHYSICIANS, 
January 2001.  It provides physicians with current guidelines for the diagnosis, 
treatment, reporting, and prevention of foodborne illness and with information for their 
patients on the prevention of foodborne illness. 
#	 OIG Recommendation: Model Linkages (Flowchart foodborne illness 
investigation and response, clarifying what different agencies could do in certain 
situations.) 
FDA Comment:  FDA agrees and its efforts to improve coordination and communication 
among public health and food regulatory officials, particularly related to foodborne 
illness outbreaks, include, but are not limited to the following: 
1.	 In December 2000, FDA participated in the release of a multi-agency report entitled, 
Outbreak Response and Coordination for Federal and State Agencies During 
Multi-State Foodborne Illness Outbreaks. This report outlines the standard 
operating procedures for the rapid exchange and release of data and information 
during multi-state outbreaks of foodborne illness. It serves to guide federal agencies, 
state, or local health officials, and state food regulatory officials involved in food or 
waterborne outbreaks on procedures for coordinating responses during a multi-state 
outbreak of food or waterborne illness. 
2.	 The National Food Safety System (NFSS) project, which includes FDA, USDA, 
CDC, and the Environmental Protection Agency, as well as states, contributes 
significantly to more effective implementation of existing food safety programs. 
3.	 The Outbreak Coordination and Investigations Workgroup of the NFSS project issued 
a protocol on how to conduct multi-state outbreak investigations. This protocol, 
Guidelines Manual for Coordinating Foodborne Outbreak and Traceback 
Investigations, addresses greater clarity about the roles of various players in an 
outbreak situation. 
27
FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400  APPENDIX A 
Agency Comments 
#  OIG Recommendation: Improved Surveillance System 
FDA Comment:  FDA has an ongoing working relationship with CDC in improving 
surveillance and shares resources for purposes of coordination, cross-training, and 
outbreak investigation. We will promote awareness amongst the states. 
Standard 6  Compliance and Enforcement: 
#  OIG Recommendations: Model Programs and Best Practices 
FDA Comment:  FDA agrees. Identification of best practices for voluntary 
compliance, enforcement, and industry recognition would facilitate implementation of the 
Standards and enhance consumer protection. FDA will examine how best to collect and 
disseminate that information and will implement this as resources permit. 
#  OIG Recommendation: State and Local Recognition 
FDA Comment:  FDAs National Registry of Retail Food Protection Programs will 
identify states and localities that meet the requirements of the Program Standards. 
Standard 8  Programs and Resources: 
#  OIG Recommendation: Testimony 
FDA Comment:  FDA has been vocally supportive of the Program Standards and State 
and local agencies routinely interact with FDAs Regional Specialists who can provide 
targeted support. 
#  OIG Recommendation: Practical Advice to Agencies 
FDA Comment:  FDA conducts outreach to spread the word about the Program 
Standards. At the NEHA meeting this summer, the Retail Food Steering Committee 
Chair provided an overview of the Standards. A video of that presentation was 
subsequently used at the National Association of Local Boards of Health (NALBOH) 
meeting. At last year's meeting of that group, the Retail Food and Interstate Travel Team 
Supervisor provided a face-to-face power point presentation and discussion about the 
Program Standards. 
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Agency Comments 
#  OIG Recommendation: Innovative Grants 
FDA Comment:  FDA agrees and plans to continue food safety grants as resources 
permit. Current plans for FY' 02 include continuation of the Innovative Grants Program. 
#  OIG Recommendation: Minimum Equipment Needs 
FDA Comment:  See the response to Innovative Grants. 
#  OIG Recommendation: Assessment Training 
FDA Comment:  Training and assistance on the Program Standards are scheduled 
through workshops planned in FY 01. Additional assistance will be provided through 
the Regional Food Specialists to the states and locals as resources permit. 
#  OIG Recommendation: Audit Process 
FDA Comment:  FDA agrees and is premiering an audit course that will include auditing 
principles. A specific Program Standards Auditing Guide is scheduled for development 
in FY 03. Since, after initial enrollment in the Standards, audits occur on 36-month 
cycles thereafter, completion of the Audit Guide in FY 03 allows a period of time for 
evaluating its use and practical application. 
#  OIG Recommendation: Certified Evaluation Officers 
FDA Comment:  FDA has anticipated that need and procedures for certifying Evaluation 
Officers are in the queue for drafting as resources become available. 
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FFDDAA  &&  RREETTAAIILL  FFOOOODD                                                                                      OOEEII--0055--0000--0000554400