, "

(( 
Department of Health and 
Human Servces

OFFICE OF

INSPECTOR GENERAL

INSPECTION 
FDA FOOD  SAFETY 
#' ,pvv 
Richard P. Kusserow 
INSPECTOR GENERA 
'0 
OEI-OS-901070  -. 
. .
" ( 
'J 

Departent of Health and Human Servces

OFFICE OF

GENERA

INSPECTOR 
SAFET INSPECTION

FDA FOOD 
ft. 
Richard P. KUllerow 
GENRA 
INSPECFOR 
AUGUS 191  EXECUTIVE 
SUMMARY

PUROSE 
The purpose of this inspection was to examine the authorities for and the 
breadth of 
fis 
domestic food safety inspections of low-risk food  conducted by the Food and
Drug Administration (FDA) and the States. 
BACKGROUN 
The FDA is responsible for assuring the safety of the nation s foods, drugs, medical 
devices, radiological products and cosmetics. Under the Food, Drug and Cosmetic 
Act, FDA's primary role in food sanitation is to monitor through 
inspections the 
conditions under which food is manufactured, processed, packed and stored. 
In response to a September 1989 General Accounting Offce recommendation that 
FDA reduce their inspections of low-risk food fis" FDA pointed out that problems 
with low-risk firms are of serious concern to the American consumer, and represent
violations of the law. These firms, FDA stated, handle food products that are 
particularly susceptible to contamiation. Large volumes of food improperly stored 
bottled beverages contaminated by mold, and the use of contamiated raw bakg
ingredients represent a potential for problems, lie outbreak of food poisonig, that 
justify the use of a high level of 
inspection coverage. 
MEODOLOY 
We contacted the 21 FDA district offces, and inspection agencies in all States, the 
District of Columbia, and Puerto Rico. We obtained descriptions of how the 
wcorkpolanningn, priordity settiig, tandi enoforcemnent proscesse.s a ctually work and how they 
might be improved. Respondents also gave their perceptions of whether low-
risk 
food safety inspections act as a deterrent to insantary food processing and storage

FIINGS 
Al  in 
se prle 
bees 
FDtAm    dupt trh   ithn   for  wi low-rk 
pfoor  FDAt h  a low  pote to  ex  Sta gi a
to  low-r foo saety  du do FDA.

fi  as  Stl Rend be th

Not al foo  ahr ela wn to FDA or th 
ar  rila  wi  sie th ar
pole pu6c 
not  un  fi  '! 
- r

into 
Foo safety  do not hae al th enforcem tols th need to do an 
efece job. 
in 
De  Fed  agen 
efor by  and State  and  grup to prmote 
unorm, no natina reqem ex for th inctn  rik foo 
of low-
fi. Conseq, th pu6c receies dieren leels of foo safety, depeg 
th geogph loatn. 
on 
RECOMMATIONS 
The FDA, working with the States, should develop and seek legislative authority for 
a system to inspect low-risk food firms based on the following priciples: 
there is a need for a complete and uniform system for 
inspecting low-
risk food firms; 
the FDA's role should be in oversight, developing standards, and 
providing technical assistance to the States; and 
the States should have the responsibilty for inspecting low-risk food 
firms. 
At a minimum, the system should include the 
followig recommendations. 
en 
sho de  th  syst
unor syst 
iTh daFDtAi n  rec oln  innbo thr ae  . 
of al foo fi an  of 
sho 
deelp 
cTh  erF DA  reemfor .lo w-rk foo saety inctns an
whih Sta met the in 
Ce 
Sta sho cond 
of low-
rik foo 
lela  inn 
FDA sho se  to prvi inr. wi th  tols 
nTh  ees. 
iinnn   fr 
sho co1l 
wTh  i fFuDA  low-rk cfoeo rsaanfne t   usaer cfee t of balo ftoho  FDAfi  an th Stuasteer  fee
th me FDA' 
COMM  TI DRA RERT 
AGENCY  TO 
We received comments from the Public Health Servce (PHS), FDA' 
s parent agency, 
Plang 
the Assistant Secretar for  and Evaluation (ASPE), and the Assistant 
Secretary for Management and Budget (ASMB). Al respondents concured in 
priciple with the recommendations. The PHS asked for refiement of several 
recommendations, and suggested that the States' intial receptity to a liage
State certifcation with the user fee be measured.  GEN 
OFFCE OF INSPEcrR  COMM 
REPONSE TO AGENCY 
Responding to PHS' suggestion, the Offce of Inspector General recontacted
States to gauge States' initial reaction to the recommendations. The States were 
unanimous in supporting the need for 
consistency in inspections. Eight of the 10
States supported the user fee concept to fund inspection activities as outlined in our 
recommendations. 
We did not provide more exact details regarding the recommendations
, as PHS 
suggested. Our view is that PHS, in concert with States, professional organizations 
and industry, should determine the exact requirements and their planned 
implementation. 
In response to concerns of ASPE and ASMB, the report was changed to indicate 
that we had no estimate of the eventual cost of the program suggested. The amount 
of the user fee in the report is 
shown as an example. 
Technical revisions to the body of the report were also made as suggested by PHS.  . . ..  ..  ..  ..  ..  ..  ..  ..  ...   ...   ...   ...   ....    ....    .....    .. ..  .  .. ..  . ..  .  .. .. ..    . .... .     ......      ......      .......       .......      .. ....   . ...  ... .  ....  
. ..  ..  ..  ...   ...   ....    ....    ....    ....    .....     .....     .....     ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      ......      .....     .....     ......      ......     . ....   . .. .. .   . . ..  ..  .. ..   .  .....      ......      .....     .....     .....     ....    ........    
TABLE OF CONTENTS

PAGE 
EXECUTIV SUMMY 
INTRODUCTION. . . . . . . . . . . . . . . . 
Purpose 
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
Methodology 
FINDINGS 
Although FDA believes that the potential exists for serious problems with low-
risk foods, FDA assigns a low priority to these 
inspections. States give a higher 
risk food safety inspections than does FDA 
priority to these low-
Not all food firms are known to FDA or the States. Respondents believe there 
are possible public health risks associated with unidentifed fis, since they are 
not inspected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
Food safety inspectors do not have all the enforcement tools they need to do 
an effective job 
Despite efforts by Federal and State agencies and industry groups to promote 
uniformty, no national requiements exist for the inspection of low-risk food 
firms. Consequently, the public receives dierent levels of food safety, 
depending on their geographic location 
RECOMMNDATIONS 
DEPARTMNTAL COMMNTS 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 . . 

APPENDICE 
Appendi A: Agency Comments on Draft Report 
Public Health Servce  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-
Assistant Secretary for Planng 
and Evaluation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-
Assistant Secretary for Management 
and Budget  . A-

Appendix B: Offc  of Inspector General Response to Agency Comments 
. B INTRODUCTION

PUROSE 
The purpose of this inspection was to examine the authorities for and the 
breadth of 
domestic food safety inspections of low-risk food firms conducted by the Food and Drug 
Administration (FDA) and the States. 
BACKGROUN 
The FDA is responsible for assuring the safety of the nation s foods, drugs, medical 
devices, radiological products and cosmetics. Under the Food, Drug and Cosmetic 
(FD&C) Act, FDA's primary role in food sanitation is to monitor through inspections 
the conditions under which food is manufactured, processed, packed and stored. Food 
firms' compliance with the FD&C Act is secured though inspections of facilties and 
products, analysis of samples, educational activities, and legal proceedings. 
Food firms engaging in interstate commerce are reguated by FDA. State and local 
jurisdictions have authority over food firms within their boundaries, whether or not 
interstate commerce is involved. 
fis 
The FDA inspects high-risk food  that manufacture products that are highly 
susceptible to microbial contamination, like mayonnaise or low-acid canned foods. 
These foods, if improperly processed, can cause problems considered to be high-risk 
like staphyloccal enterotoxin and histamies. 
The FDA inspects low-risk food firms, which they defie as bakeries, bottlers and food 
fis 
warehouses. The tyes of foods found in low-risk food  vary widely. In bakeries 
one would encounter raw foodstuf such as flour, sugar and eggs, as well as fished 
frt 
products lie bread anfd ip.as tries. Soda pop, mieral water, and  juices are bottled 
or canned at bottlig  Food warehouses store any raw materials or fished 
foodstufs, from sacks of coffee beans to cartons of breakfast cereals. 
Many FDA fidigs of insanitary conditions or practices are resolved through voluntary 
fis 
compliance from the 
rather than interdicting the suspect foodstufs by a Federal 
court warrant, a lengty and labor-intensive process. Whe all States have embargo 
authority, or imediate seize power over domestic food products, FDA lacks this 
seize 
immediate  authority. Ths often makes it necessar for FDA 
to rely on States 
to detain adulterated food products. However, States' defitions of "adulterated" may 
differ from FDA's and, as a result, they may not be able to comply with every FDA 
embargo request.  Many factors impact on the level and frequency of inspection coverage of low-risk food 
firms. The FDA relies on its headquarters to provide national 
guidance through its
Compliance Program Guidance Manual and on its 21 district offces to set priorities for 
low-risk food safety inspections. These district offces consider the full range of their
other FDA inspection responsibilties, such as high-risk food firms, pharmaceutical firms 
and blood banks, in determining how many low-risk food safety inspections they will 
undertake. 
Staffing levels also affect ths planning. 
fis 
The FDA' for inspection. The FDA 
s strategy is to target violative  district offices 
consider food firms for inspection based on a combination of the following priorities: 
knowledge of the existence of potential problems; 
firms that produce a food product with a history of causing potential 
health problems; 
firms inspected during the past 6 years with violations serious enough to 
warrant product seizure, prosecution and/or injunction; 
firms that have never been inspected; and 
fis 
that have a violative history on a national level. 
The FDA currently supplements its inspections by contracting with 36 States  to conduct 
food inspections. The FDA district offces perform audit inspections on a percentage of 
the firms inspected by States under contract. 
The General Accountig Offce (GAO) issued a report in September 1989 entitled 
FDA Could Improve Inpection Program to Make Better Use of Resources.
" The 
fis 
GAO recommended, in part, that FDA reduce its inspections of low-risk food 
fis. 
States that routinely inspect these 
fis 
In response, FDA pointed out that problems with low-risk  are of serious concern 
to the America consumer, and represent violations of the law. These fis, FDA 
stated, handle food products that are particularly susceptible to contamination. Large 
volumes of food improperly stored, bottled beverages 
contamiated by mold, and the 
use of contamiated raw bakig ingredients represent a potential for problems, lie 
outbreaks of food poisoning, that justi the use of a high level of inspection coverage. 
Thoughw th repn, an rem:e to "th Sta inAu both Pu Rio an th Dit of Co/ui4  METHODOLOY 
OUf inspection focused on FDA and States low-risk food safety inspection activities of 
domestic bakeries, bottlers and food warehouses. We considered these activities in light 
of the full range of responsibilties for these agencies. 
This inspection was primarily a system review. No evidence gathered indicates an 
increase in food contamination. Rather, we addressed the potential for 
problems and 
methods to avoid them. We did not examine the methods used to inspect firms, nor 
perform any qualitative review of the inspections being performed. 
Through open-ended discussions with the 21 FDA district offce directors, we elicited 
information concerning their workplanng processes, use of resources, enforcement 
techniques, and the setting of priorities for low-risk food safety inspections. We 
personally visited FDA district offces in: Bufalo, New York; Baltimore, Maryland; 
Chicago, ilinois; San Francisco and Los Angeles, California; Orlando, Florida; 
Nashville, Tennessee; Kansas City, Missouri; Denver, Colorado; and the Indianapolis 
Indiana resident post of the Detroit, Michigan district offce. The other district 
directors were intervewed by telephone. 
We also contacted all States to obtain simar information from State agency directors 
with responsibilty for conducting low-risk food safety inspections. On-site contacts were 
made with State agency heads from New York, Rhode Island, Indiana, Florida 
Tennessee, Californa, Kansas and Wyoming. 
During our on-site visits at FDA district offces and the State agencies, we held 
discussions with food safety inspectors2 to obtain descriptions of how the workplanning, 
priority setting, and enforcement processes actually work, how they might be improved 
and their perception of low-risk food safety inspections as a deterrent to insanitary food 
processing and storage conditions. 
The FDA and all States, with the exception of Georgia and Ohio who did not respond 
to our data request, provided quantitative data reportg the extent of low-risk food 
safety inspections being conducted by their agency. Some States and FDA were unable 
to respond completely because the inormation requested was not collected by them, or 
was not accessible in the detail we had requested. 
th  dl 
2Discuns we 
1M  States th job tiw ivthar d. In eawh hCoD #p eorm loth w-riint orfs oo Slfetw e  intri ensle fAotr  Fa DrAa,n gteh  of iwen  n. iannt onorst  loird in vsoelgelay rto!  loAwt  
rik food safet inctions  FINDINGS

FIING 
1: Althoug FDA believes tht the potential exts for serious problems with 
low-rik foo FDA asign a low priority to thes inpectons. States gie a higher
priority to thes low-rik foo saety inpectons th doe FDA 
The FDA, and their State counterparts, strongly contend that low-risk food safety 
inspections encourage good sanitary practices on the part of food firms. However 
FDA district offces, and a few State 
inspection agencies, often treat these inspections 
as less important than their other responsibilties. 
Most respondents believe that low-risk food safety inspections act as deterrents against 
insanitary practices in the food industry, and feel that more low-risk food safety 
inspections should be conducted. 
Nineteen FDA district directors and 49 State inspection agency directors agree that 
low-risk food safety inspections serve to prevent insanitary conditions from becoming 
widespread. A commonly advanced notion is that fis become lax in food sanitation 
practices if they know that there is little lielihood of being inspected. Many feel their 
inspection presence compares to that of "a cop on the beat. 
The problems inspectors encounter when they conduct low-risk food safety inspections 
include: (1) rodent and insect defiement; (2) failure to comply with standards of 
identity (these define what a given food product is, its name and the ingredients which 
must be used, or may be used, and which ones must be declared on the label); (3) use 
of unapproved food and color additives; (4) product substitution; (5) short weight; and, 
(6) insanitary storage and processing conditions. 
Because of these problems, and the deterrent value of low-risk food safety inspections 
14 of the FDA district diectors, and 30 State diectors feel they would lie to see more 
low-risk food stafhety  inspections performed. No FDA ditrict diector, and only one 
State director  there should be a decrease in the inspections being performed. 
he 
inca 
Resnd  th pu6c  safety is ennced by peormg low-rik foo 
safety 
fis 
Some respondents express concern that although these 
are categoried as low-risk, 
there are public health risks associated with the food products handled by low-risk 
fis. Most tyical was the notion that "low-risk does not mean no risk." Respondents 
point out that the understandig of the potential hazrds associated with food and food 
processing is constantly changig, and requies a constant re-evaluation of the risk 
identified with a particular food. For example, unti 199, fresh tomatoes were not 
known to carr any strains of salmonella contamination.  - (

Most problems caused by ingesting adulterated low-risk food are admittedly unlike the 
more serious problems connected with high-risk foods. Contaminated high-risk foods 
we were told "can kill you;" .. but (eating an adulterated low-risk food) "just makes you 
wish you were dead. 
prri 
Low-rik foo safety inctins ar consed a low  by FDA ditrt offes. 
Overwhelmingly, FDA district offces do not feel that low-risk food safety inspections 
are a high priority. Twenty of the FDA district directors describe low-risk food safety 
inspections as being a low priority, with the other director characterizing it as of 
medium importance. Most FDA district directors feel that given current resources and 
other responsibilties, this treatment of low-risk food safety inspections is appropriate. 
Because of its large workload and limited resources, FDA must establish priorities for 
its inspections. In doing this, low-risk food safety inspections may not necessarily have 
the same importance as some other inspections. 
We do not suggest that FDA' s priorities are misplaced. Low-risk food safety 
inspections should not be placed above the vital need to inspect high-risK food firms, 
blood collection facilties, drug manufacturers, or makers of medical devices. 
The FDA district offces are given considerable latitude in determng how their 
inspection resources are expended. Ths discretion is offset by the need to respond to 
new FDA headquarters' priorities, or to react at once to public health emergencies. 
Each FDA district offce must react to the district s imediate needs as well as to 
national crises. 
Typically, low-risk food safety inspections are postponed or cancelled when crises arise, 
or if new demands are made on the FDA district offces. Al FDA district offces 
report havig to cancel low-risk food safety inspections to react to potentially dangerous 
public health hazards, lie the 199 incident involving cocaine in the imported beverage, 
Malta  when caned and pickled mushrooms from China caused several 
" or in 1989, 
, lie 
food poisoning outbreaks. Secretarial intiatives the curent focus on proper 
will also impact on FDA distrct 
labellng of products,  offce inspections. 
In some instances, FDA may not be able to reschedule low-risk food safety inspections. 
For example, in 1989 FDA planned to conduct 14 145 food inspections themselves (not 
rik 
exclusively low- inspections). By year s end, FDA conducted only 54 percent of 
their planned food inspection work.  ':  ."" 
. l' 
consbly reed th nuer 
FDA ha  rik foo ji incte 
Th  of low-
The number of bottlers, bakeries, and food warehouses inspected by FDA has 
decreased by 44 percent since 1985. In 1985, FDA inspected 3 339 different bottling, 
baking, and food warehouse establishments. In 1989, only 1,868 such establishments 
were inspected by FDA Some firms are inspected more than once in a year in order 
to verify that a violative condition is corrected. These figures do not account for all of 
the low-risk food safety inspections that FDA conducted, since some firms receive more 
than one inspection during a year. These follow-up inspections are not included in 
FDA' s inspection count. 
During this time period, a combination of factors caused FDA to devote less resources 
to low-risk food safety inspections. Two major factors were the declining number of 
inspectors each year, and those inspectors available being frequently used for other 
priorities. 
The following chart ilustrates the decline in the number of low-risk food firms 
inspected by FDA No inspections performed by States under contract are included. 
Other FDA inspections
Decline in the Number of 
of food fis, which
Low-Risk Firms Inspected by 
FDA  includes high-risk firms 
1985 1989 
dropped 39 percent 
from 1985 to 1989. In
3600 
contrast, the number of
.00....'..''' ...  2.822''''''''..''  fis 
3000  2;58.0.''''''''....'''''''''''.'''.''''''''''  inspected in the
2500 
non-food FDA program 
975 
2000  .'00'.'.."."."0000"""''''''''''.00'.'''..''''''''..00''''''.''.'' ......00...  8..  areas has remained 
1500  ""'''''..'''00'.'''''''''''''.''0000'''''''''''''''.00'.''.''''''''.''..00'.''''.'''''""''''00 fairly stable since 1985. 
..0000."""'"'''''''00'..''''.''''''..''.''.'''''''''''''''.'''..'''''''''''''''''''''........  Inspection of firms in

000 
these centers declied
."""'''''.''''''''''''''.''.'00'''00'''''''''''00'''''''''''''''.'''''''''''''''''''..''.
600 
only 6 percent during 
188  1888  1887 1888  1888  this period.
".r 
. 8oFttoeonl.l  ......h.,o,e..e.
e 
Respondents expect that 
199 
inspection data 
show an increase in the 
fis 
number of low-risk food  inspected by FDA, due to staff 
increases. This expected 
increase is not surrising since FDA district offces frequently use low-risk food safety 
inspections to train new staff in inspection procedures and documentation.  ............................................................................................. ....."........'....."......'.....'......................................... ...."......'........"......".......".............................................. ....................................... ......................................................................................................'."......'.'...'.'...'.'............
fi 
Th  FDA ha alo reded th nuer of low-rik foo  State inct un FDA 
contct 
The FDA relies heavily on State contracts to ensure low-risk food firms' compliance 
with the FD&C Act. In 1989, contract inspections comprised 75 percent of the bakery 
inspections conducted, 74 percent of the bottler inspections conducted, and 70 percent 
of the warehouse inspections conducted for FDA. 
Despite FDA's dependence on State contracts, the number of low-risk establishments 
inspected by States under FDA contract, has decreased by 33 percent since 1985, from 
859 firms to 4 577 firms. The following chart reflects this decline in the number of 
low-risk firms inspected under FDA contract. 
Several reasons explain 
Decline in the Number of Low-risk 
this decline. Reduced 
funding for contracting  Firms Inspected Under Contract.
1985-1989 
restricted the number of 
inspections the States 
8000 6,
could perform. Also, in  859 
7000 
some cases the FDA 
8000  5;62''''''''''''.''''''''''''''''.'''''''''.'''''''.''''''''''' 
district offces chose to  4577 
assume more of this  11000  3;790.".'.."""..'.  ;2'S7"'."" 
workload, and in others  4000 
States opted not to do  3000 
''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''.'''.''''.....n.............

as many contract  2000 
1000 
inspections as before.

fis  18815  1988  1887  19aa  19a9 
'I.'
The number of 
B.,.,I8. 
. Bott.,., WIt8lI... 
inspected under contract  .lId FrHd 
began to rise in 1988 
and 1989 as FDA 
respoindend to  GAO recommendations to do so. 
age  hi 
prri  inns th 
State  gie a  to low-rik foo safety 
FDA. 
Unle FDA distrct offces, most State diectors do not consider low-risk food safety 
inspections to be of low priority. Twelve State diectors consider low-risk food safety 
priority for their agency, whie only 10 States feel it is of low 
inspections to be a high 
import. The other State diectors either characterie these inspections as of medium 
fis. 
priority, or make  dierent tyes of 
distinctions in priority for  ...
. i 
The States' responses to the priority of low-risk food safety inspections often are
colored by their agency s varied inspection activities. Frequently, States would describe 
one tye of low-risk firm as being of high priority, while downgrading the importance of 
other tyes. Connecticut, for example, considers bakeries to be a high inspection 
priority, bottlers a medium priority, and warehouses a low priority. In contrast
, Hawaii
considers warehouses and bottlers high priorities
, with bakeries a medium priority. 
Choosing which tye of firm is more likely to be in violation or considered a potential 
health hazard, varies by State and often reflects current problems a State is 
encountering with a particular firm or product. 
Like FDA district offces, State inspection agencies often have responsibilty for many 
, and must respond to emergencies. Postponing or cancellng 
tyes of inspections
inspections to react to these exigencies is commonplace. Characteristically, one State 
agency director said dthat " i 
(the inspections of) foods are the fist to get sacrificed. 
fi 
No relible estite of th total nuer of low-rik foo  beig inpecte by State is
availble du to th  reponig 
of State 
fis 
The number of different  receiving low-risk food safety inspections under State law 
and not under FDA contract, is unkown. Whe 
exact figures are not available, we do
fis 
know that States conducted at least 37 00 
inspections of low-risk food  in 1989. 
fi 
The level of inspection coverage for a particular  depends on the State
fis 
requirements and priorities. Some  receive more than one annual inspection 
because of States' mandated multiple inspections, or due to reinspection to ensure that 
insanitary conditions found previously are corrected. 
Although most State diectors feel the number of low-risk food safety inspections has 
remained constant in recent years, this impression is not unversal. Fourteen said that 
over the last 3 years their 
agencies were doing fewer low-risk food safety inspections; 11 
said they were performg more inspections durig thi period. Trendig data 
describing the number of low-risk food safety inspections conducted by the States was 
requested, but generally was not avaiable. 

fi 
FIING 
2: Not al foo  are know to FDA or the States. Respofndien ts 
asted 
believe there are poible public heath riks  with undentied  since 
inpeed 
they are not 
There is no national registry of food fis, either mandated or voluntary. The current 
techniques that identif fis who process anfd ist ore food products do not guarantee 
that all will be identified. IT a low-risk food  is not identifed, it wi continue to 
fis 
manufacture, process, store and ship food that is not inspected. Thus  operating
in insanitary conditions wi continue to do so unchecked, placing the public s health at 
risk.  /i 
ad 
do hae  inven 
FDA  an  of foo  but 
Th  it is not complete  or  up to date. 
The FDA tracks food firms through the Offcial Establishment 
Inventory (OEI). The 
GEl is a computerized data base containing information on 
establishments whose 
activities fall within FDA' s jurisdiction. As of August 1990, there were 28 700 bakeries 
bottlers and food warehouses on the OEI.  The OEI is updated by FDA district 
offices. Although the FDA district offces feel that most firms are identified in the 
GEl, 17 of the 21 FDA district offces believe that the identification of food firms could 
be improved. The FDA district offces currently use a variety of methods to identify 
these firms. 
The FDA relies on its inspectors to identify food firms to update the OEI. Since there 
is no systematic procedure to identify new food fis, inspectors do so by reviewing 
newspapers, magazines, phone books, industry publications, trade periodicals, 
surveilance reports, and consumer complaints. Inspectors may also walk through stores 
looking for new products. 
To a degree, all FDA district offces count on notification and referrals from the States 
to identify food firms and update the OEI. A memorandum of understanding between 
the State of New York and the Brooklyn and Bufalo district 
offces formalizes the 
exchange of inventories between these agencies. In most instances however, inormal 
networks provide this exchange of information. Twenty States routinely share their 
inventory lists with FDA Most of the States commented that they would furnish FDA 
with a copy of their inventory lists if FDA requested it. Twenty-nie States said that 
FDA routinely shares its OEI with them. 
The lack of timeliness in adding firms to the OEI presents problems for inspecting 
agencies. Firms could be operating for some time without FDA (or the State) being 
aware of it. Durig this period, these firms would not be subject to food safety 
inspections, nor be requied to 
correct any violations. Insanitary conditions could 
rife, or adulterated raw materials could be used durig 
processing, or fiished products 
could be stored improperly. 
Shifting priorities and decreasing resources withi FDA has affected the contents of the 
OEI. As of a result of these factors, an auxary OEI fie was established in fiscal year 
Firs 
1981.  are removed from the active OEI and transferred to the auxary fie if: 
(2) their products or activties no longer fall under FDA' 
(1) they are out of business; 
jurisdiction; (3) their annual sales are less than S500,OO and they sell 75 percent or 
more to retail customers on the premises; or, (4) the FDA determes that the 
cannot be covered within curently avaiable resources. Establishig the auxar OEI 
fis. 
freed FDA staff to concentrate on larger 
fi 
3 Th acru coun of  coul be sm sie an eslihm cou be cowu in more th one cazry.  However, updates to the auxliary OEI are infrequent. Firms in this inactive inventory 
could easily change the nature of their business, or grow larger, without FDA' 
knowledge. Whether they would ever be transferred to the active OEI, and subject to 
FDA inspection, is problematic. Like firms who are never identified by inspecting 
agencies, these auxliary OEI firms may be operating with food safety violations, and if 
, represent potential public health risks. 
fi  fi 
ad 
Most States mainin invenori of foo  but  not all foo  are 
Forty-two States license, register, or issue operating permits to food firms. Most States 
rely heavily on self-identification by food firms to comply with their requirements. 
Some States require an annual license, while others merely demand a one-time 
registration. Sometimes it is the local government, rather than the State
, that licenses 
food firms. 
fis. 
Like FDA inspectors, State inspectors take an active role in identifyng food 
Using techniques similar to FDA inspectors, State inspectors act as "eyes and ears" to 
identify new firms. Often, these inspectors hafvies a n assigned geographic terrtory and 
through the years come to know most of the  operating in their jurisdiction. 
However, even with mandated licensure or registration and the best efforts of inspectors 
fis 
to identify food fis, most States believe they are not identifyng all the food 
operating in their Sftaitse.  In New York City, a respondent estimates that one-fourth of 
the operating food  are unkown to the State, despite mandatory licensing. States 
also report problems tracking seasonal operations.  id
he  fi 
The are pole pu6c  riks asocte wi  not beig 
agen. 
inpectin 
Food firms operating without the knowledge of inspection agencies can produce, 
manufacture, pack, and store food that is adulterated and/or 
mislabelled. Unless 
problems arise, like an outbreak of food poisonig, that identify these firms, they may 
never be inspected. Routinely conducting low-risk food safety inspections not only 
serves to act as a deterrent against insanitary food products, but also educates firms and 
their employees about safe food handlng. 
FIING 3: Foo saety inpeors do not have al the enforcement tools they need 
to do an effece job. 
The food industry is becomig increasingly complex. New products, equipment, and 
packagig are constantly being developed, and each change poses new potential risks to 
consumers. Without comprehensive reguatory and enforcement powers, inspectors are 
at a disadvantage in protecting the public s health and enforcing the food safety laws.  , "
cant imtely  prts 
FDA inctors  imtes ee, or emaro, foo  foun tht appear
cTh ontmite 
All State have  emaro autri. 
The FDA lacks the power to immediately embargo suspected adulterated foodstuffs 
found while conducting an inspection. The FDA process to seize adulterated foodstuffs 
entails a Federal court action, whether the product is considered high or low-risk. 
While this legal process is underway, potentially dangerous foodstuffs can be shipped 
The FDA seizure 
and subsequently, sold to the public.  process can take several weeks. 
One FDA district manager related that when it does effectuate a seizure order  it' 
rare the entire lot is there when we return. 
In some cases, the FDA turns to the States to effect an embargo to prevent potentially 
Because of the potential health risks associated 
hazardous foods from being marketed. 
with contaminated food, the States treat FDA embargo requests as high priority. 
However, the possibilty exists that the food in question will be transported before the 
State can act. 
Seventeen FDA district directors feel that not being able to immediately embargo 
violative foodstuffs hinders them, and could present a public health risk. An FDA 
district director said he finds it  this authority, since he sees 
frstrating not having 
immediate embargo as an essential element of consumer protection. 
Twenty of 21 FDA district directors believe FDA should have immediate embargo 
power. Although FDA gives States considerable credit for responding to their requests 
States cannot always immediately embargo on FDA' s behalf. For example, the State 
may not have an inspector available either due to a State holiday or the logistics of 
travel to the inspection site. 
All States have the power to imediately embargo suspected adulterated food. In 
some States, the embargo continues indefitely, whie in others the embargo must be 
lifted if no legal action has been initiated in a specifed time period. In the latter 
instance, agreeing to assist FDA with an embargo could present a problem, if Federal 
court action on the cae is not accomplished tiely. One State embargoed a product 
called "Oil of Priose " at FDA's request. The FDA seize took several months to 
accomplish. Durg ths time, the State was continually pressured by the firm to release 
the embargoed product. 
An FDA embargo request can pose other diculties for States. Some States requie 
their own inspection to conf FDA's fidings prior to embargoing. If the problem 
not present when the State inspection takes place, the State cannot embargo. One 
State could not embargo at FDA's request when their inspectors could not fid the 
product infestation that the FDA inspector had. Ths  inested 
suggests that either the 
product was shipped or destroyed before the State could inspect, or that the inspection 
conducted by the State was different than that conducted by FDA.  Joint FDA- sometimes conducted when problems are known to 
State inspections are 
exist, or are anticipated. But the geographic spread of low-risk food firms, and the 
relatively few numbers of inspectors mitigate against joint inspections, or even same-day 
State inspections in many cases. 
States cannot always comply with FDA embargo requests, although this is rare. 
Violations found by an FDA inspector must also be violations under State law, and 
under the jurisdiction of the inspecting agency before the State can embargo the 
product. In some instances, violations of the FD&C Act are not violations of State law 
and no embargo can be enacted. 
th inctin authori  mo Sta. 
Th FDA inctors lack  used by 
The FDA inspectors do not have the authority to access low-risk food firms' shipping, 
Alost 
, formulation and complaint records.  all FDA district 
biling, quality control
authorities a hiderance 
offces consider the absence of these record review  in their 
While FDA can obtain records via a Federal court warrant 
inspection of these firms. 
this is often a lengthy and involved process. Four FDA district offces commented that 
they have asked States to obtain records on their behalf. 
Shipping and bilng records readily prove the interstate nature of a firm s business 
required for FDfAi  jurisdiction. Presently, FDA spends considerable inspection resources 
provig that a  ships or receives goods from other States. These shipping and 
vital in expediting the recall of adulterated products from the 
billig records are also 
marketplace. 
Quality control and complaint records are important for pinpointing problem areas that 
Access to formulation records would help ensure 
deserve special inspection attention. 
that product labelling is correct. 
In contrast, most States have access to al records in question. Many State inspection 
agencies have the authority to review any record needed to conduct their inspection. 
indidual tyes of records, but 
N at all States give express statutory authority for 
inspectors may request the records they feel are necessary. 
Fort-one States have the authority to access bilg and quality control records. 
Fort-three States have access to shipping records. Th-six States can inspect 
formulation records. At least 30 States can review consumer complaint records, while 
another 8 States are unsure if this is specifcally authoried in their State statutes.  ex aUl 
ta phtoph dug 
FDA /Qc/C  to  inctins.
Th 
Although FDA has the right to take photographs under normal inspection procedures 
that right has been questioned because the statute is not explicit on this point. All 
FDA district offces think that photographs are invaluable in documenting violations. A 
graphic depiction of a violation is especially valuable in the event of prosecution, or can 
obviate the need to litigate. Twenty of the FDA district offices state that they routinely 
take photographs of suspected violations. 
Thirt-nine States report photographing conditions in a firm while conducting 
inspections. 
FIING 
4: Depite effort 
by Federa and State agencies and industr groups to 
pfroim.o te unormty, no national requiements ext for the inpeon of low-rik foo
Consuently, the public recives dierent  foo saety, dependig on 
levels of 
their geogrphic loction. 
The FDA and State low-risk food safety inspections often differ, both in the focus as 
well as the breadth of the inspection. While many States have laws patterned after the 
FD&C Act, there are considerable variations. Some States do not have the authority to 
inspect all 
tyes of low-risk food firms. 
inns 
ar 
Not all low-rik foo safety 
The FDA district  perform under contract are 
directors feel that the inspections States 
generally well-done. However, two-thids of the FDA ditrict diectors believe that the 
inspections States perform, not under FDA contract, are not equivalent to those 
performed by FDA 
No national requiements for conducting low-risk food safety inspections exist because 
no means of obtaing  been fully successfu. 
consistency from State to State has 
Because of the dierent standards and requiements of FDA and State laws, low-risk 
fis 
food  fia,r e often held to diferent inspection requiements. An inspection of a 
low-risk  uncoverig no violations, could take efiithse r 30 miutes or 3 days 
depending on who performs the inspection. Also  that operate in dierent States 
may have to meet diering Stafties in spection requiements for the same product. Ths 
can cause confsion for these  in deciding what should be stressed to guarantee 
minimum level of food safety. 
Most State directors believe that the quality of their low-risk food safety inspections is 
equal to those done by FDA inspectors. However, many States concede that the 
degree of inspection documentation demanded by FDA exceeds that usually collected 
by their inspectors. Ths dierence, as well as FDA's emphasis in laboratory sampling 
, ensues from the FDA posture that each violation may result in 
of suspected foodstuffs
legal action.
 Where there are State mandated inspections of firms, there are considerable demands 
on State inspectors to inspect these firms timely. However, perforce, only the obvious 
violations may be uncovered. One State director said that they look for "the 3 B's 
birds, bats, and bugs." One State inspector said that he performs "flashlight 
inspections " implying that he scans the flashlight beam around the facilty to find 
violations. 
fi.
freq 
FDA hi no mtndte inctin  rik foo 
Th  for low-
Based on workload demands and current priorities, each FDA district offce decides 
which low-risk firms in their district will be inspected and how often. 
fi 
freq 
inctin  var wily. 
State  for low-rk 
In contrast to FDA, 30 States are mandated by law or policy, to periodically inspect all 
low-risk firms, or certain tyes of low-risk firms. Of these 30 States, 14 report that they 
try to inspect establishments annually. Others have statutes mandating inspections as 
often as six times annually. 
However, adherence to these inspection frequency requiements is problematic. The 
State inspection agencies frequently have responsibilty for a wide range of inspection 
activities. Like FDA, States must deal with resource shortages, other organizational 
priorities, and the need to respond to emergencies. 
When scheduling low-risk food safety inspections, States also consider whether local 
entities, such as city or county health departments, do their own inspections of low-risk 
food establishments. States must coordiate with local inspecting agencies to avoid 
fis. 
duplication of effort, and to spread inspection coverage to more 
Unlike FDA, not all States perform low-risk food safety inspections of bakeries, bottlers 
and warehouses. For example, Mississippi has no authority to inspect food warehouses 
under State law. In Idaho, local authorities have complete responsibilty for food safety 
inspections; the State neither conducts food safety inspections nor exercises any control 
over these agencies. Montana acts mostly in an advsory role to the local county health 
departments, usually gettng involved if an enforcement action is necessary. 
li 
comp 
The 
is 
da sha  on 
Information sharing by States on completed low-risk food safety inspections is meager. 
The information shared is usually problem-based, not routine. Less than half of the 
States share any inspection inormation with FDA Sixeen States share their inspection 
findings only if a problem or violation is involved; and three States supply FDA with 
their inspection results only if an interstate problem occurs. Only six 
States routinely 
share all their inspection results with FDA.  The FDA does not always share inspection data with all of the States 
either. Only 
14 States report that FDA routinely provides them all FDA inspection findings. 
Seventeen State diectors said that FDA will send them information on any firms found 
to be violative. Ten more States report that they occasionally receive FDA inspection 
results. The remaining States report receiving no FDA inspection results. 
The are some efort to prmote unorm in foo safety inctins. 
The FDA, the States, and the food processing industry have taken some steps to foster 
consistent requirements for food processors and consistent food safety inspection 
criteria. These steps include training both for  , the 
industry and inspection agencies
contracting of FDA inspections, and the development of common standards that help 
ensure that food manufacturing, processing, packing and storing is done under strict 
sanitary conditions. 
The FDA promotes uniformity in low-rik food safety inspections through regulation, 
trainin& and contracting. 
The FDA has issued seven Good Manufacturing Practice Reguations (GMPs) for food 
processing since 1969.  The GMPs describe the mimal conditions and controls that 
food firms must use to produce food products that meet the standards of the FD&C 
Act. The purpose of these GMPs is to prevent violative products from being produced 
and marketed. The FDA uses these GMPs to evaluate sanitary conditions and 
practices in the food industry. 
The FDA State Training Branch offers training to State and local reguatory agencies 
on a wide range of topics. Short-term courses are offered tution free, and are 
presented on location at the requesting agency. The courses are designed to meet the 
specific training needs of the sponsoring agency. The Trainig Branch solicits 
recommendations from States concerning their trainng needs and States bid yearly for 
the courses they want. The FDA trains and certifes many State inspectors to conduct 
different tyes 
of inspections. 
By providig traing and techncal assistance to inspection agencies, FDA helps 
defig, 
promote a consistent approach to  identifyng, and correcting the potential 
health hazrds found at food manufacturers, processors, packers and warehouses. Even 
fis 
though indidua State requiements for these  dier, FDA can present an 
inspection traing course that applies the precepts of the FD&C Act tailored to their 
laws. Enrollent is open to other agencies and industr applicants if training slots are 
available. 
hu 
4Th GMPs cove:  (1)  CW goh mm/faaclt ug practie in m/factur, pres& pa& or holdg  foo (2)  smd 
panr oscmekes-efldr eldo wfi-ha; cid foods p(6a) clfcrgzeedc  inr auw b radd fsieha;l dan  conl (7) pre(3s) ga caidnfi db fooo ttg o(4f)  bcoactatdo  pdrortgs  awna tc.on ftrTi h GMP's(5 )f or cacao 
produclS an smked fih Q1e not  in efct.  Many State agencies praised FDA'  , citing both the expert level of the 
s training efforts
trainers and the content of the courses. But many lament that budgetary restraints 
prevent their staff from attending, or that they cannot afford to attend more than once 
every 1 or 2 years. 
Another form of FDA training that promotes not only uniformity of approach, but also 
better information sharing, is the joint inspection. In these instances, an FDA and 
State inspector form a team to conduct an inspection. In recent years, due to staff 
shortages, there have been relatively few joint inspections conducted. 
The FDA contracts with States to conduct low-risk food safety inspections require a 
common approach and reporting of the fidigs. The FDA demands that States 
performing inspections under contract use FDA methods, requiements, and forms. 
Aside from the uniformty demanded by FDA in conducting inspections under contract 
fis. 
States set their own guidelines for inspecting low-risk food safety 
The inspections done under contract usually requie more inspection time, product 
A spin-off 
sampling, and documentation than those normally performed by States. 
effect of contracting is that States sometimes adopt FDA techniques or use FDA forms 
to perform their own inspections. 
Hazard Analysi Critical Control Point Programs focw on quality control standards. 
The FDA, food processing industry, and professional organiations embrace the concept 
of Hazard Analysis Critical Control Point Programs (HACCP). The HACCP is a 
quality control approach that identifes the processing steps where food contamination is 
most likely to occur. At these points, the product is tested for microbiological, chemical 
and physical hazards. 
Although the HACCP concept is one that can be applied unversalflyi t.h roughout the 
food industry, the critical control points wi var for each tye of  In food 
warehouses, for example, a critical control point might occur durig their effort to 
eliate 
rodents. However, a bottler of sprig water may not tyically have rodent 
infestation, but would face problems to guarantee the purity of their water. 
Establishig critical control points where the water purity is monitored would reflect the 
risk poinft iw here inpection needs to take place. Ths HACCP specifcity for each tye
of food  helps assure the quality of the product. 
The food processing industry has taken the lead in promoting HACCPs. In conjunction 
with FDA in many cases, they develop HACCPs for specifc 
tyes of food processors 
and offer traing on their application. Compliance with HACCPs is voluntary.  RECOMMENDA TIONS

The FDA is responsible for the safety of most of the nation s food supply. To 
accomplish this formidable task, and stil have the resources to tackle their other duties 
we believe that the inspection of low-risk food firms should be restructured. 
This restructuring is necessary because of the vital ongoing need to inspect low-risk 
food firms coupled with FDA' s need to ,devote more resources to their higher priorities. 
At present, the frequency and the quality of these inspections varies greatly. Little 
information is shared on completed inspections, and consequently some firms are 
fis 
inspected by both FDA and States, while other  are not inspected at all. Any 
duplication of inspection effort takes away scarce resources from FDA' s other activities. 
The FDA, working with the States, should develop and seek legislative authority for a 
system to inspect low-risk food firms based on the followig principles: 
there is a need for a complete and uniform system for inspecting low-risk 
fis; 
food 
the FDA' , developing standards, and providig 
s role should be in oversight
techncal assistance to the States; and 
the States should have the responsibilty for inspecting low-risk food firms. 
At a minimum, the system should include the elements described in the 
recommendations below. 
RECOMMATION 1: The FDAf shio uld desgn a unorm sytem that ensures both 
a sytematic identication of al foo  and collecon of inpeon results. 
The FDA should ensure that all food fis, high-risk and low-risk, are registered. Ths 
fis 
wi 
registry  help ensure that all food  fisa re identifed, and therefore subject to 
inspection. To guarantee that all food  are subject to inspection, registration by 
firms should be mandatory. 
Options include FDA developing and maintaing a single national registry, or havig 
each State keep its own registry. In either case, data should be shared between FDA 
requig 
and States. Options for enforcing registration include  either a Federal food 
permt, a State license for food fis, or another form of user fees as discussed in 
Recommendation 5.  , . 
fRiE.C OMMATION 3: Certed States should conduct inpectons of low-rik foo
States certified by FDA should conduct all low-risk food safety inspections in their
State. The FDA would monitor States' compliance with the inspection requirements 
perform quality control reviews, and provide ongoing training to the States. The FDA 
would recertify States periodically. 
If a State does not meet the inspection requirements, FDA should arrange for the 
inspection of low-risk food safety inspections. The FDA could perform these 
inspections, or contract with a certified State, or other entity they deem qualified. 
We do not anticipate that all States will be able to meet all of the proposed FDA 
requirements immediately. Some States may 
fis  choose not to meet the requirements. In 
these cases, the food  in these States should be held to the same inspection
requirements as food firms in certified States. 
RECOMMATION 4: The FDA should sek legilation to provde inpectors with
the inpecton tools necess. 
The FDA should obtain 
authority for inspectors to imediately embargo suspected 
adulterated products, review all necessary records, and clarify the right to photograph 
suspected violative practices. These inspection authorities should apply equally to all 
FDA-regulated products. 
Currently, the FDA's lack of immediate embargo authority can allow adulterated foods 
fis 
to get into the marketplace. Many low-risk  receive and ship foodstuffs daily. 
Even an expedited Federal seizre process cannot prevent the shipment of all foods 
suspected of being adulterated. 
The FDA should not have to rely on State offcials, or the vagaries of State statutes to 
prevent adulterated food from being sold to the public. Likewise, using both FDA and 
State inspectors to inspect the same 
materials in order to justif a State embargo for
FDA, is a redundant use of resources. 
An additional issue to consider is how Federal authority 
could be delegated or 
otherwse used by certed States when conducting low-
risk food safety inspections. 
fis 
Al food  should be presumed to deal in interstate commerce, as is the case with 
fi,
Th 
medical device manufacturers.  presumption could be rebutted by the food 
but the burden of proof would fall to them. Elinatig the requiement that FDA 
prove their jursdiction allows them to make better use of scace resources.  The registry should also receive, and share information on 
inspections of food firms 
whether conducted by FDA, States, or local entities. The registry should furnsh 
information to these agencies on inspections conducted by others. Information on firms 
operating in more than one State can be provided to all States involved. 
Inspection results, positive or negative, are vital to agencies tryng to plan their 
inspections. Problem areas found during another agency s earlier inspections can be 
stressed when a new inspection is conducted. Additionally, the sharig of this data will 
fis 
eliminate some of the duplicative inspections of  by different agencies, since an 
agency will know when the firm was last inspected. 
RECOMMATION 2: The FDA should develop requiements for low-rik foo 
cert 
saety inpectons, and  which States meet thes requiements. 
These requirements should be based on FDA' s long experience in inspecting low-risk 
food firms, and their extensive knowledge of risk analysis factors associated with the 
different tyes of low-risk food fis. The FDA should also solicit input from States 
the food industry, and professional 
groups in developing these requiements. 
The requirements might vary by food, the size of the facilty, and all of the 
considerations FDA currently uses to decide when to inspect a low-risk food firm. The 
requirements should include miimum inspection frequency requirements. 
Also to be considered is a fi's adoption of HACCP or their use of GMPs in food 
processing or storage. Firms that follow these priciples, and provide access to 
inspectors that allow monitoring of these requiements,  requie 
fis.  should not  inspection as 
frequently as other 
The FDA should certif which States meet al requiements for conducting low-risk food 
traig 
safety inspections. The FDA curently provides specialed  for States in many 
inspection areas. The FDA should continue to provide traing for States, with special 
emphasis for those States working toward FDA certcation, as discussed in 
Recommendation 5. The new focus on training would emphasize preparing States to 
meet the proposed inspection requirements.  , "
RECOMMATION 5: The FDA should collec an inpeon usr fee from al 
foo fi. Th usr fee wi paral fud foo saety inpecton actties of both 
FDA and the States that meet FDA's certcation requiements. 
A July 1990 OIG report  Implementing User Fees in the Food and Drug 
Administration " indicates that applying the collected user fees to inspection activities 
would be consistent with the way some Federal agencies fund their inspection activities. 
The total user fees collected should not exceed the FDA and States' costs for these 
activities. 
The additional funds made available from the user fees would encourage many States 
to strive to meet these inspection requirements. The public, as well as many food 
firms, would also want their States to meet food safety inspection requirements and 
become FDA certified. 
Food firms benefit from an inspection program that provides uniform requirements, 
which also helps to assure the public of the quality of the product. So, firms that adopt 
HACCP or follow GMPs might 
qualify for a discount in the user fee. 
Collection of these fees could be accomplished in several ways. The FDA could devote 
additional resources to compile a registry of al food fis, with concomitant staff to 
collect fees and enforce non-collection. Or, States could collect the user fee through 
the licensure process.

Another option would employ the Internal Revenue Servce (IRS) to collect the user 
fees. The IRS could add a reporting lie on tax returs for businesses involved in the 
food industry to compute their user fee. The IRS could receive a flat percentage of the 
collections to compensate them for their expenses. 
The FDA should end the curent contractig of low-risk food safety inspections with 
State inspection agencies. Ths would represent annual savigs of more than 
$2.5 millon. States would be supplemented for the loss of contracted inspections with 
, if they adhere to the inspection requirements designed by FDA 
a share of the user fees
and become certed. 
The FDA would not share any of the inspection user fees collected with States not 
certifed. These fuds would be used for FDA resources necessary to conduct the low-
risk food safety inspections, or arrange for their performance in those States.  Although we have not estimated the costs of restucturing the food safety inspection
program as described, initial costs are likely to be high. User fees should be used to 
fund all food inspection activities. These user fees will fund FDA high-risk and low-risk 
food safety inspections, with certified States 
receiving a portion to fund their low-risk 
food safety inspections. The FDA will retain the balance of the user fees to fund the 
registry of firms, the development of standards, the certification and re-certification 
processes, and training. Other uses of the user fees could include additional inspection 
staff, expansion of laboratory operations, or contracting for the maintaining the registry. 
As an example, a user fee of one-tenth of one percent on the gross sale of all food and 
kindred products would generate $513 millon annually on sales of 
$513 bilion. In 
contrast, FDA funding for all food safety activities in 1989 was $132 milion. Collection 
of the proposed user fees would allow curent operating funds to be redirected to other 
non-food inspections. 
The share to States who meet the inspection requirements should equal half of all user 
, up to $256 milion in our 
fees collected in their State. Half of these collections
example, would be earmarked for States meeting the proposed FDA requirements. 
This potential funding dwarfs the $2.5 millon currently expended for State contracts by 
FDA. In fact, in 1986, 48 States reported food inspection expenditures totallg 
approximately $121 millon. With the user fees, certifed States could conceivably 
expand their low-risk food safety inspection coverage, whie reducing 
the State outlays 
for food inspections. 
Again, the user fees collected should not exceed the FDA and States' costs for these 
activities. 
COMM 
DEPARTMAL 
We received comments from the Public Health Servce (PHS), FDA' 
s parent agency, 
the Assistant Secretary for Planning and Evaluation (ASPE), and the Assistant Secretary 
for Management and Budget (ASMB). Al 
concurred in priciple with the 
recommendations. Both ASMB and ASPE questioned the need to collect $513 annually 
in user fees. The PHS proposed contacting States to determine their 
receptivity to the 
recommendations and fuher refiement of the user fee concept, as well as making 
several technca 
revisions to the report. 
On the basis of the reviewers' suggestions , we made several techncal corrections to the 
report. We have clarified that collection of $513 mion in user fees represents one 
revenues that could be collected though  , rather than an 
ilustration of possible  the fees
wi 
estimate of how much revenue 
need to be generated.  We recontacted the food 
safety inspection agency in 10 States to discuss the 
recommendations. Eight of the ten States supported the user fee concept to fud 
inspection activities and the proposed linkages to FDA certification, as outlned in the
report. The comments of the States are presented in more detail in Appendi 
Although we appreciate the need to further refie the user fee concept, this should 
properly be addressed in the development of an implementation plan by PHS. As 
PHS 
indicated in its response, such an implementation plan will need to be consistent with 
FDA' s comprehensive user fee strategy.  APPENDIX A

AGENCY COMMNT ON TH DRA REORT  "' 
. DEPARTMENT OF HEALTH 
ANO HUMAN SERVICES 
!ssist 
uc Secretary for aeal 
Office of Inspee or General Dr  eport " FDA ?ood Sate

lnspdc  I-u5-90-01070  ft 

" O 
Inspector General, OS

be PUD ic aealch Service (paS) comaeAt. OD the 
At cached are 
s ubj e C  e couear with each  ecomaeud  t ions.
ijovever .d raf we noerepo.rt. that 1a  aentatio  of thesofe   .reco8mendationA
woula raqair  1fieanc chan.ei in 1. 
1.1.tiY. authoritiea
at./F  d.ral r 
1.t1u 
5h1p&. & d luud1Di of FD4 op.ratiQ 
of che. e cnauges . reiardless of their aerie. can ot oe S. 
impl..eDced by .PHS a  oa.. 
Ja 
O. Mason
J.aIsJe8 O. Xason. K. 
D.. Dr. 
.\c  ac:hllenc 
c:c: 
ES/PHS  #3353 
OH. Ra. l7 -25. P.rkla 
. Ra.  -13. Parkl..n

a. 17&-13. Park avu 
DPH, 
CPAHiBl:e :DF K: ICillen.. C  . 06/04/91
01133'31 
A 
 .., 
COMMNTS OF TGH BPUNBLI C HETH SERVICE (PHS) ON TH 
OPPICE
OF INSPECTOR 
(OIG) DRAFT REPORT "FDA FooD SAFETY
INSPECTION. " 01H-05-90-0107Q 
OIG RECOMATION 
FDA should desiqn a unfo  fir 
system that ensures both a
systemtic id8nt1fication of all food 
and collection
of inspection result.. 
PHS COMMNT 
We concur in principle. 
A national system for the uniform

collection of state and r.ceral Lnspectional results would b

desirable, Howeer, 
unless Cenqress leqi81ates increased
paricipated in 
authori ties for rCA and unle.. States  A federally
supervised 
:food inspection sY8tem, 1t. value would be 
ths 
questiona:ble. The reqistry system described in  report would 
tim 
ten. i ve 
dbe evarvy reesoluorc8p   and maintain.  in te  of costs and  to Doth
RECOM 
OIG  ION 
requ8ment8 for 
FDA should develop  low-risk food safety
inspections, and certify which Sta tee meet these

requiremen t8 . 
inspetions of 
Certified States should conduct 
low-risk food
firm. . 
PHS COMMNT 
part. 
We concur in  Standard rerements for 
low-risk food 
g54ofoet yid ien8ap.e cC uiroenn8t lpye,r fSo rm byu FnDer a ncfdo: ntlthr ea cStt awtietsh  wPoDul,d  dbdei a 
perform inllP8e  1on. of low-zo18i: food  u81nq PDA methods,
requirement., and fO%m. 
However, peA does net have the author! ty to reqre 
tiQipat.  S1:atea to
1ft a ce  lf1C&t1on proram. Stat.. arteh .q.p.a rate
anti  retainng 
ties, hi8torical17  the ri;ht to 40  their own 
an uner their ow 
way, on their own schedule, 
laws unless
specifically preempted. 
A certfication p o;ram tor -low-risk 
inspeions wold 
food safety  .t Federal Santation and
Good XAufacturinq Practice. (reGM) requlation. P:88mt state
requla. tions . 
develope and 
If in tact a cert fication proqraumn wleere   a State 
chose not to participate or va.  to meet the reqirements,
PCA, it-salf, would have 'to d.o the inpection. 
AddJ.:tiO!1lly, in
the pa8t, when preempted, may St:  leqi.8la  ur.. have elimnated 
A 
 funding State program in favor of other State priorities such as

schools, roads, and prisons.

OIG RECOMM  ION 
FDA should seek leqislation to provide inspectors with the

ools necessar. 
inspection 
PHS COMMNT 
We concur. Once a violation is utnocoovle. red, emargo or seizure may 
be the most important requlatory  However, to uncover 
powrs, 
violations, FDA needs access to reco  s, subpoena  and 
other inspection authorities.  roposad a 
In 1990,e FDnA forcemnt leqislation that 
comprehen8iv. packaqe of enhanced 
sub8equently was approved by the Deparen.1:. The DEmS General 
Counsel has for.ulated the proposals into la;islative languAge 
OM for 
that 18 being considered by  o Congress as 
s reqeste8ubdssioft  l.qislation 
for fiscal 
yparte ofa thre  A1dnis9trat9ion2 
 . If subtted 
and act8c favorably upon b7 Congress, 
thi. leqislation would proY de the tools recomended in the OIG

report . 
OIG RECOMMNDATIOH

FDA should eolleet an in.paction user f.. trom all food

paially 
firm . Thi. user fe. will  fund fooc1 safety 
inspection activit1.. of both FDA and Stat.. that meet FDA'

tlon reqement.. 
certif ica 
COM 
PHS 
We celiev. the fea8ibility ot implementing thi. recommendation 
numr 
depends on a  of considerations. The most obvious factor 
would be the receptivity of the S at8' to the proposed financial 
l1.aq.. to 
and certification  PDA. Ini tiel reactions f:c a 
their view 
sampling of state officials reqard1n  on the merits 
of this proposal would be a very practical addition to the final
report . 
tht 
A second, 
 ut less obviobuse, tfwact othr e fee 4beuseernve 8 closer attention 
in the repfoorto i. 8 parity  on damstic and 
imported  As the propo8al 8unda, 
it 1. silent on how
food. I 
8ales-ba88d fees 1fuld. be applied to imorted  would
st=enqten the r.c  th8 sale.-
dation to . Amj ft. hew  ba..d fee 
imrtee tood whle con:foz:g to 
approach could be ezend.8d tao n taiff 
con.train 
various inta:ntional trade 
wold 
A third factor thAt  increase the receptivity to this 
opolal i8 a mo:. developien draut8iotnr.l e for  fQrm fee ra 
on all lev.l. of the fo04  A8 it 8the tands, whol.e8alers 
A 
 pay most of these fees, since the value of food at the

will 
wholesale level is qreater 
 an at the manufacturer level, yet

FDA and .tate inspection efforts spend more tim& en maufacturers 
and proce..or8. In addition, profit magins are typically much
thinner at the wholesala level, &0 the relative impact of a
constant ra 
e fee will be dieproportionat81y burensome on
wholesalers. 
A two-level fee structure would certainly be possible, but the 
rationale would need to be .ufficien ly crisp to prevent drift 
toward a complicated multi-tiered fee Iyatem that would be too 
cumersome to admnister. Conceptually, this recommendation 
maaqinq fedsral 
pre8ents a no el approach to  and .tate food
inspection resources. 
Its viability will depend considerably on 
hew well the final report refines the idea and explores it.
feasibility. 
pl8ment user fees for food Lnspections 
Finally, any attempt to 

needs to be considered in the contest of the comprehensive user 
fa. strategy. The Office of the Secretary has asked PDA to 
develop na blueprint for haw ast. to dev81cp a ratic1\l mechanism 
aqe01, 
fer achieving Conqrese1onal, induat2:, f....  and public
consensus on the ..  li.hment of u..  The tihnosr mation on
food 1nspeetionl develope 1ft the final version of  OIG 
report will be consifd.e.r..e d by PDA in it. preparation of the 
blueprint fer user 
COJO6. 
'IECHRICA 
t.ast 
Paae 1. oaraqraph  sent8nce:  Mayonnise and many 
other hiqh risk tOOQ8 do DQ present a botulism hazard. 
Rather there  other problem t:8" may cause, such 
as staphyloccaue l ent. Qtozin an histame., which ar8 
considered to be high ri.k. 
Paae 2. sent.nce 2:  Should read, -The FD 
relies on its 
Pro  thuqh its
h.adquarter. to provide national gudance 
an 
Compliance  Guidace Kaual  OD it. 21 district
offices to set their ow 
local priorities. 
limted 
Secau.e of ita larqe wcrkloac1 and 
resources, FDA must ..tablish prioriti.. for its
inspeions, in 
doinq thi., low-risk food .afety inspections 
sam  CD other
may not necessarily have the  importance .a .
inspetions. 
, 1  iJ--:::a 
ha:  bOe:a   ::c1er
ha 
norml in8pection pJcedur8.,  to 
tha't ri;htt:h  s  questioned
becaus8 the statute is not ezlic  on  poin 
A 
 paae 13. last caraaraoh, sentence 
No national

reqirements e%ist, because no means of obtaLninq

consistency from State to State has been fully successful. 
paae 15. ;ootnote: 
6 .	 The seven GM' s cited are not all still 
in effect. The one on cacao produets and the one On smoked 
fish are not in effect. A new GM on 
smoked fish is 
presently under consideration and changes in the GM' 
s for 
bottled water are being considerea. 
Paae 20. caraaraDh 3t  The word " foodstuffs" should be 
replaced wii: thtl word . products I  To read, "Reoommnded
inspec 
ion authorities should apply 8qually to all FDA
requla tad prOducts. 
ru 
aae 22, paragracU. 
To 
such 1m expanded
sentence 
laboratory operation davoted to low-risk food., FDA would
tional FTs 
need add!  and money from Conqres8. 
A 
 :J Ii ' 
DIPAaTMINT O' HEALTH. HUMA SUVICD 
C. 2D' 
41O,. Q,
MA 
xu.erov 
TO)  Richard P. 
In.pactor Gearal 
Aa. istant Secretary tor
FROM: 
planinq 
and !Valuation 
roo 
Safety In.paction, 
OIa Draft Report: -FD 
StJBJECT : 
011-05-90-01070 
Drtt Report, 8Pn roo Safety 
01e; 
I have reviewed the 
In.paction, 8 and I concu with the t1rat four 
rec08andation. 
ba. placed on 
the report. The cU.
.ini.hin9 priority 
too tira coupled vith their 118it84 
in.paction of low ri.k  1f an 1feffici.nt 
record btahat  reslt8c 
a.yutahto.r.i toyf  tfoo oac .cae.fe. tyfi irnap action  reqire. FD to .upplament
autea to 
conduct the
it. effort. by contractin9 vith 36
 tor.4 
inapeiona. 
The rec08andation. for a un1fora .y.t.. 80ni 
by FD with certification of .Ute. to conduct 1npac:1ona woulc! 
cuant 
ell8inate  1ffeifrf.ic.1 ancie8 an r..ult 1f 80re frequent 
1f.pactiona of all 
r808endation, 
the coll
 ion of uat..r..

wi th r8Card to the fifctho llec  anually 
tu  $513 a111ion 
tfo.e ., tbteh per copreo.aatlio tno  of a unifom 818t- a. vell .. 11n unsear pction 
an ..y  total 
be exce..1ve. In 1... 
activfiut11e.n i . unjuatifi84  .illion. 
for all foo 
rnA  aafety activiti.. va.n oin.l.y  $132 
enanc..anU voulel  the co.t of
tIht ei C. u\nacnleta r vby p
 (t132 a1l110n) al80.  fou-fold ($513
.illion). I caZo'uai  conc  I'08Pen 
dation five vithout 
vith  fM exnditure.. 
exlantion an jU8  1fioation for the 112: 
A 
 . '
0f 
DEPARTMENT OF HEALTH. HUMAN SUVICts  of th S8lQy 
Wanl 
AP  ton, O.C. 20201
I s  1 6 1991 
KDORAOX  us.erow
ch d
 eneral 
it E. 
ley
nOM  i.tan 
As.  Secretary  for Manaqement ana Buaget 
StJJ_Cf  OIG Draft Report Entitled "FDA Food
Inspection" 
While we concu with the Report as written, we would like to 
user fee. ($S13 .illaliroenr p er year) 
point out that the amount  ot 
which the report recommend. FDA collect is far  than the 
foo 
level of resource. curently 
devoted to  .afety. The $513
million fique 
larger than FDA t . planed FY 1992 u.er fee
i.  160' 
collection. from all  larger than the

reglated indu.trie.,  304'
FY 1992 amount budgeted for the field operation. of the Center

for Food Satety and Applied Nutrition, and 67. ot FDA' s entire FY

t1h9e9r2e  baurdeg eutj.o Sri n.actee ttyhe p Rreopobrtl -doe. not present informawtei othn intkha t

in the food industr, 
that the ciudeean otlfy c ollecting .0 .uctho omo re trom the tood industry 
than i.  being spent on  .afety will be difficult to
justify. It 
might be advantaqeou. to pre.ent the $S13 million
f ique 
a. an illustration ot th. amount of user te.. which could 
ba.ed on .al... Alternatively, th. $513 
be raised from user  t... 
million could repre.ent .everal y.ar. of f.. collection 
tir 
With re.pect to the oth.r recomendation., we aqree tha 
.hould be undatory 
reqi.tration of food  (recommendation 1) 
bein to tae 
and that .tat.. .hould  over re.ponsibility for 
inspectinq low risk too tira within th.ir bord.r. 
(recommendation 3). W. al.o agree that FDA should seek

leqi.lation to provide ita inv.stiqators with additional
authority 
(recomm.ndation 4) and note that such leqislation is
pre.ently uner r.vi.w at OMI. 
Whil. we certainly do not oppose 
PD 
the idea ot  developinq specific .tandards for low risk food 
cost of 
inspection. (recomm.ndation 
2) we are concered that 
developinq such .tandard. aiqht not be ju.titied by the 
indu.trie.. 
hi.torically low ri.k po.ed by th.se 
A 
 -" 
, ",
APPENDIX 
GEN 
COMM 
OFFCE OF INSPECfR  REPONSE TO AGENCY  l' 
OIG REPONSE TO PHS CO 
We welcome the support for the recommendations in our draft report and at the 
same time appreciate the concerns raised in the Public Health Servce s (PHS) 
response to the draft report, especially in emphasizing that they cannot act 
unilaterally on any of the recommendations. As the report points out, none of these 
recommendations can be implemented without congressional action. And 
considerable FDA-State cooperation and coordination is vital to the acceptance and 
success of the changes suggested.

We recontacted a random sample of 10 States to determne their initial receptivity to 
the user fee concept, and to the other recommendations that would affect State 
inspection activities. The States were unanious in supporting the need for 
supported the user fee concept to 
consistency in inspections. Eight of the 10 States 
fund inspection activities. 
Some State concerns about the recommendations included the effect on State 
funding and State user fees, the proposed division of the user fees, and the 
preemption of State and local statutes by Federal standards. 
fudig 
Our view is that the user fee suggested could replace much of the State  for 
low-risk food safety inspections, and may reduce some of the curent State budgetary 
concerns as it regards food safety inspections. The user fees should allow 
fuding of low-
risk food safety inspections for certifed States. 
starg a 
We expect that the intial  national program that encompasses a 
costs of 
national registry, collection and dissemiation of inspection results, a certifcation of 
State inspection agencies, the performance of all low-risk food safety inspections in 
non-certifed States, the expansion of traing and techncal assistance to States, and 
wi be 
increased laboratory testig  costly at fit. However, as the program matures, 
a different sharg of the user fees might be in order. 
We feel that the proposed requiements should alow for State or local requiements 
to requie stricter controls on food where they feel the need exists. However, the 
standardid inspection requiements should be not reduced as a result of lesser 
State or loca requiements.  , . 
,-,
.., 1

The PHS also mentioned extending the user fee to imported foods. However
, this 
inspection was limited in scope to low-risk domestic food products. We cannot 
speculate on ways to include imported food products under these 
rubrics. 
In addition, PHS suggested a two-level user fee schedule. The recommendation we 
made was not intended to be restrictive. Instead, as with 
suggesting a reduction for 
firms adhering to HACPs, or suggesting that IRS might serve as the collecting 
agent for the user fee, we feel there are many possible ways to approach these 
concepts. 
Technical revisions to the body of the report were made as suggested by PHS. 
COMM 
OIG REPONSE TO ASPE 
We welcome the support for the recommendations. The ASPE did 
question the 
need for the amount of the proposed user fees in the draft report since it would 
generate nearly four times the current expenditures for FDA food 
safety inspections. 
The report was changed to indicate that we had no estimate of the eventual 
cost of 
the program suggested. The amount of the user fee in the report is 
shown as an 
example. 
Although we have not estimated the costs of restructuring the food safety inspection 
program as described, initial costs are likely to be high. User fees should be used to 
fud all food inspection activities. These user fees wi fud FDA high-risk and low-
risk food safety inspections, with certifed States receivg a portion to fund their 
low-risk food safety inspections. The FDA will retain the balance of the user fees to 
fis, 
fund the registry of  the development of standards, the certifcation and re 
certification processes, and 
trainig. Ukewise, State expenditures would liely 
increase to meet the demands of certcation. 
Additionally, we expect that the level of inspectons conducted by States would be 
raised, and the frequency of inspections increased in many instances.