, 

(( 

Department of Health and Human Servces


OFFICE OF


INSPECTOR GENERAL


FDA FOOD SAFETY INSPECTION 

#' ,pvv 

Richard P. Kusserow 

INSPECTOR GENERA '0 

OEI-OS-901070 
( . . .

'J 


Departent of Health and Human Servces


OFFICE OF


INSPECTOR GENERA


FDA FOOD SAFET INSPECTION


ft. 

Richard P. KUllerow 

INSPECFOR GENRA 

AUGUS 191 
EXECUTIVE SUMMARY


PUROSE 

The purpose of this inspection was to examine the authorities for and the breadth of 

domestic food safety inspections of low-risk food fis 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 

workplanning, priority settig, and enforcement processes actually work and how they 

might be improved. Respondents also gave their perceptions of whether low-risk 

food safety inspections act as a deterrent to conditions. insantary food processing and storage


FIINGS 

Al FDA bees dut th pote ex for se prle wi low-rk 

foo FDA tm a low pr to th in Sta gi a pr to th low-r foo saety in du do FDA.


Not al foo fi ar lawn to FDA or th Stl Rend be th


ar pole pu6c he rila as wi un fi sie th ar

not 
! 

- r


Foo safety into do not hae al th enforcem tols th need to do an 

efece job. 

De efor by Fed and State agen and in grup to prmote 

unorm, no natina reqem ex for th inctn of low-rik foo 

fi. Conseq, th pu6c receies dieren leels of foo safety, depeg on th geogph loatn. 

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 lowrisk 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. 

Th FDA sho de unor syst th en both a syst idatin of al foo fi an coln of inn re. Th FDA sho deelp re for low-rk foo saety inctns an cer whih Sta met the reem. 

Ce Sta sho cond in of low-rik foo 

Th FDA sho se lela to prvi inr. wi th inn tols 

nees. 

Th FDA sho co1l an inn user fee fr al foo fi user fee

wi fu low-rk foo safet in act of both FDA an th State 

th me FDA' cern 

AGENCY COMM TO TI DRA RERT 

We received comments from the Public Health Servce (PHS), FDA' s parent agency, 

the Assistant Secretar for Plang 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. 
OFFCE OF INSPEcrR GEN REPONSE TO AGENCY COMM 

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 lowrisk foods, FDA assigns a low priority to these inspections. States give a higher 

priority to these low-risk food safety inspections than does FDA 

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AAssistant Secretary for Planng 

and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AAssistant 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. 

The FDA inspects high-risk food fis 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 

warehouses. The tyes of foods found in low-risk food fis vary widely. In bakeries 

one would encounter raw foodstuf such as flour, sugar and eggs, as well as fished 

products lie bread and pastries. Soda pop, mieral water, and frt juices are bottled 

or canned at bottlig fi. 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 

compliance from the fis 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 

immediate seize 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. 

The FDA's strategy is to target violative fis for inspection. The FDA 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 

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 fis 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. 

2Discuns we with th who peorm low-ri foo Slfet At FDA, th 

1M States th job ti vard. In eah CD# th we 

inti we dl intors or invegar! At 

intors rensle for a range of inn. an not lid solely to low­ 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 safety inspections performed. No FDA ditrict diector, and only one 

State director th there should be a decrease in the inspections being performed. 

Resnd inca th pu6c he safety is ennced by peormg low-rik foo 

safety 

Some respondents express concern that although these fis 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. 

Low-rik foo safety inctins ar consed a low prri 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 " or in 1989, when caned and pickled mushrooms from China caused several 

food poisoning outbreaks. Secretarial intiatives, lie the curent focus on proper 

labellng of products, will also impact on FDA distrct 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 

exclusively low-rik inspections). By year s end, FDA conducted only 54 percent of 

their planned food inspection work. 
: .

. l' 

Th FDA ha consbly reed th nuer of low-rik foo ji incte 

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 

3600 from 1985 to 1989. In

.00....'..''' ... 2.822''''''''..'' contrast, the number of 3000 2;58.0.''''''''....'''''''''''.'''.'''''''''' fis inspected in the 2500 

975 non-food FDA program 2000 .'00'.'.."."."0000"""''''''''''.00'.'''..''''''''..00''''''.''.'' ......00... 8.. areas has remained ""'''''..'''00'.'''''''''''''.''0000'''''''''''''''.00'.''.''''''''.''..00'.''''.'''''""''''00 1500 fairly stable since 1985. 

..0000."""'"'''''''00'..''''.''''''..''.''.'''''''''''''''.'''..'''''''''''''''''''''........ 000 Inspection of firms in


600 ."""'''''.''''''''''''''.''.'00'''00'''''''''''00'''''''''''''''.'''''''''''''''''''..''. these centers declied

only 6 percent during 

188 1888 1887 1888 1888 this period. ".r 

. 8otten. ....,,...


Fooll ...hoeee Respondents expect that 

199 inspection data 

show an increase in the 

number of low-risk food fis 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. 
................................................................................................ 

.............................. .............................................. ........ ............................................................................................ .......................................................................................... ................................. .

Th FDA ha alo reded th nuer of low-rik foo fi 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 

this decline. Reduced Decline in the Number of Low-risk 

funding for contracting Firms Inspected Under Contract.

restricted the number of 1985-1989 

inspections the States 8000 6,

could perform. Also, in 859 7000 

some cases the FDA 

district offces chose to 8000 5;62''''''''''''.''''''''''''''''.'''''''''.'''''''.''''''''''' 

4577 11000 

assume more of this 3;790.".'.."""..'. ;2'S7"'."" 

4000 

workload, and in others 

States opted not to do 3000 

''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''.'''.''''.....n.............
 2000 

as many contract 1000 

inspections as before.


'I.' The number of fis 18815 1988 1887 19aa 19a9 

. Bott.,., B.,.,I8. 

inspected under contract .lId FrHd WIt8lI... 

began to rise in 1988 

and 1989 as FDA 

responded to GAO recommendations to do so. 

State in age gie a hi prri to low-rik foo safety inns th 

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 

inspections to be a high priority for their agency, whie only 10 States feel it is of low 

import. The other State diectors either characterie these inspections as of medium 

priority, or make distinctions in priority for dierent tyes of fis. 
...

. 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 

tyes of inspections, and must respond to emergencies. Postponing or cancellng 

inspections to react to these exigencies is commonplace. Characteristically, one State 

agency director said that " (the inspections of) foods are the fist to get sacrificed. 

No relible estite of th total nuer of low-rik foo fi beig inpecte by State is availble du to th di of State reponig 

The number of different fis receiving low-risk food safety inspections under State law 

and not under FDA contract, is unkown. Whe exact figures are not available, we do

know that States conducted at least 37 00 inspections of low-risk food fis in 1989. 

The level of inspection coverage for a particular fi depends on the State requirements and priorities. Some fis 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. 


FIING 2: Not al foo fi are know to FDA or the States. Respondents 

believe there are poible public heath riks asted with undentied fi since 

they are not inpeed 

There is no national registry of food fis, either mandated or voluntary. The current 

techniques that identif fis who process and store food products do not guarantee 

that all will be identified. IT a low-risk food fi is not identifed, it wi continue to 

manufacture, process, store and ship food that is not inspected. Thus fis operating in insanitary conditions wi continue to do so unchecked, placing the public s health at 

risk. 
Th FDA do hae an inven of foo /i but ad 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 

1981. Firs are removed from the active OEI and transferred to the auxary fie if: 

(1) they are out of business; (2) their products or activties no longer fall under FDA' 

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 

freed FDA staff to concentrate on larger fis. 

3 Th acru coun of fi 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. 

Most States mainin invenori of foo fi but ad not all foo fi 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. 

Like FDA inspectors, State inspectors take an active role in identifyng food fis. 

Using techniques similar to FDA inspectors, State inspectors act as "eyes and ears" to 

identify new firms. Often, these inspectors have an assigned geographic terrtory and 

through the years come to know most of the fis operating in their jurisdiction. 

However, even with mandated licensure or registration and the best efforts of inspectors 

to identify food fis, most States believe they are not identifyng all the food fis 

operating in their State. In New York City, a respondent estimates that one-fourth of 

the operating food fis are unkown to the State, despite mandatory licensing. States 

also report problems tracking seasonal operations. 

inpectin 

The are pole pu6c 

agen. 

he riks asocte wi fi not beig id

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. 
, 

Th FDA inctors cant imtely see, or emaro, foo prts foun tht appear contmite All State have imte 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 

and subsequently, sold to the public. The FDA seizure 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 

hazardous foods from being marketed. Because of the potential health risks associated 

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 frstrating not having this authority, since he sees 

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 suggests that either the inested 

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-State inspections are sometimes conducted when problems are known to 

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 FDA inctors lack th inctin authori used by mo Sta. 

The FDA inspectors do not have the authority to access low-risk food firms' shipping, 

biling, quality control, formulation and complaint records. Alost all FDA district 

offces consider the absence of these record review authorities a hiderance in their 

inspection of these firms. While FDA can obtain records via a Federal court warrant 

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 FDA jurisdiction. Presently, FDA spends considerable inspection resources 

provig that a fi ships or receives goods from other States. These shipping and 

billig records are also vital in expediting the recall of adulterated products from the 

marketplace. 

Quality control and complaint records are important for pinpointing problem areas that 

deserve special inspection attention. Access to formulation records would help ensure 

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. 

N at all States give express statutory authority for indidual tyes of records, but 

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. 
Th FDA /Qc/C ex aUl to ta phtoph dug inctins.

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 

promote unormty, no national requiements ext for the inpeon of low-rik foo fi. Consuently, the public recives dierent levels of foo saety, dependig on 

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. 

Not all low-rik foo safety inns ar 

The FDA district directors feel that the inspections States perform under contract are 

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 consistency from State to State has been fully successfu. 

Because of the dierent standards and requiements of FDA and State laws, low-risk 

food fis are often held to diferent inspection requiements. An inspection of a 

low-risk fi, uncoverig no violations, could take either 30 miutes or 3 days 

depending on who performs the inspection. Also fis that operate in dierent States 

may have to meet diering State inspection requiements for the same product. Ths 

can cause confsion for these fis 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 

of suspected foodstuffs, ensues from the FDA posture that each violation may result in 

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. 

Th FDA hi no mtndte inctin freq for low-rik foo fi.

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. 

State inctin freq for low-rk fi var wily. 

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 

duplication of effort, and to spread inspection coverage to more fis. 

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. 

The is li da sha on comp 

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 industry and inspection agencies, the 

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 

promote a consistent approach to defig, identifyng, and correcting the potential 

health hazrds found at food manufacturers, processors, packers and warehouses. Even 

though indidua State requiements for these fis 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. 

4Th GMPs CW go m/factug practie in m/factur, pres& pa& or holdg hu foo cove: (1) (2) 

procesed low-acid foods paclcged in hmal seald conl (3) acidfid foo (4) cacao prots an conftri (5) smd an smke-flred fih; (6) frze raw bradd fih; (7) an presg an bottg of bottd drg wat. Th GMP's for cacao 

produclS an smked fih Q1e not cu in efct. 
Many State agencies praised FDA' s training efforts, citing both the expert level of the 

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 

States set their own guidelines for inspecting low-risk food safety fis. 

The inspections done under contract usually requie more inspection time, product 

sampling, and documentation than those normally performed by States. A spin-off 

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 unversally throughout the 

food industry, the critical control points wi var for each tye of fi. 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 point where inpection needs to take place. Ths HACCP specifcity for each tye of food fi 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 

inspected by both FDA and States, while other fis 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 

food fis; 

the FDA's role should be in oversight, developing standards, and providig 

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 FDA should desgn a unorm sytem that ensures both 

a sytematic identication of al foo fi and collecon of inpeon results. 

The FDA should ensure that all food fis, high-risk and low-risk, are registered. Ths 

registry wi help ensure that all food fis are identifed, and therefore subject to 

inspection. To guarantee that all food fis 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 

and States. Options for enforcing registration include requig either a Federal food 

permt, a State license for food fis, or another form of user fees as discussed in 

Recommendation 5. 
, 

RECOMMATION 3: Certed States should conduct inpectons of low-rik foo fi. 

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 choose not to meet the requirements. In 

these cases, the food fis 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 

to get into the marketplace. Many low-risk fis 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. 

Al food fis should be presumed to deal in interstate commerce, as is the case with 

medical device manufacturers. Th presumption could be rebutted by the food fi, 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 

eliminate some of the duplicative inspections of fis 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 

saety inpectons, and cert 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, should not requie inspection as 

frequently as other fis. 

The FDA should certif which States meet al requiements for conducting low-risk food 

safety inspections. The FDA curently provides specialed traig 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 

a share of the user fees, if they adhere to the inspection requirements designed by FDA 

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 lowrisk 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 

fees collected in their State. Half of these collections, up to $256 milion in our 

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. 

DEPARTMAL COMM 

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 

ilustration of possible revenues that could be collected though the fees, rather than an 

estimate of how much revenue wi 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 " O I-u5-90-01070 ft 


Inspector General, OS


At cached are be PUD ic aealch Service (paS) comaeAt. OD the 

s ubj e C draf e couear with each of ecomaeud t ions. report.

ijovever . we noe. that 1a aentatio of these .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 S. 

of che. e cnauges . reiardless of their aerie. can ot oe impl..eDced by .PHS a oa.. 

IsJ Ja O. Mason J.ae8 O. Xason. K. D.. Dr. 

.\c ac:hllenc 

c:c: 

ES/PHS #3353 

OH. Ra. l7 -25. P.rkla 

. Ra. -13. Parkl..n
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.., 

COMMNTS OF TH PUBLIC HETH SERVICE (PHS) ON TH OPPICE OF INSPECTOR GBN (OIG) DRAFT REPORT " FDA FooD SAFETY INSPECTION. " 01H-05-90- 0107Q 

OIG RECOMATION 

FDA should desiqn a unfo system that ensures both a systemtic id8nt1fication of all food fir 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

authori ties for rCA and unle.. States paricipated in A federally supervised :food inspection sY8tem, 1t. value would be 

questiona:ble. The reqistry system described in ths report would be vary resourc8 ten. i ve in te of costs and tim to Doth develop and maintain. 

OIG RECOM ION 

FDA should develop requ8ment8 for low-risk food safety inspections, and certify which Sta tee meet these
 requiremen t8 . 

Certified States should conduct inspetions of low-risk food firm. . 

PHS COMMNT 

We concur in part. Standard rerements for low-risk food 

54fety in8pec ion8 perform by FD and the States would be a 

goo idea. Curently, S uner contract with PD, ddi perform inllP8e 1on. of low-zo18i: food f:l u81nq PDA methods, requirement., and fO%m. 

However, peA does net have the author! ty to reqre S1:atea to tiQipat. 1ft a ce lf1C&t1on proram. Stat.. are ..parate anti ties, hi8torical17 retainng the ri;ht to 40 thq. their own 

way, on their own schedule, an uner their ow laws unless specifically preempted. A certfication p o;ram tor -low-risk 

food safety inspeions wold re .t Federal Santation and Good XAufacturinq Practice. (GM) requlation. P:88mt state requla. tions . 

If in tact a cert fication proqram were develope and a State 

chose not to participate or va. unle 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


inspection ools necessar. 

PHS COMMNT 

We concur. Once a violation is uncovered, emargo or seizure may 

be the most important requlatory tool. However, to uncover 

violations, FDA needs access to reco s, subpoena powrs, and 

other inspection authorities. In 1990, FDA roposad a 

comprehen8iv. packaqe of enhanced enforcemnt leqislation that 

sub8equently was approved by the Deparen.1:. The DEmS General 

Counsel has for.ulated the proposals into la;islative languAge 

that 18 being considered by OM for 8ubssioft o Congress as part of the Adnistration 
 s reqested l.qislation for fiscal 

year 1992. 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


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


certif ica tlon reqement.. 

PHS COM 

We celiev. the fea8ibility ot implementing thi. recommendation 

depends on a numr of considerations. The most obvious factor 

would be the receptivity of the S at8' to the proposed financial 

and certification l1.aq.. to PDA. Ini tiel reactions f:c a 

sampling of state officials reqard1n their view on the merits 

of this proposal would be a very practical addition to the final

report . 

A second, 
 ut less obvious, factor tht 4eserve8 closer attention 

in the report i8 parity betw the fee buen on damstic and 

imported foo. As the propo8al 8unda, it 1. silent on how 8ales-ba88d fees 1fuld. be applied to imorted food. I would st=enqten the r.c dation to . Amj ft. hew th8 sale.-ba..d fee 

approach could be ezend.8d to imrtee tood whle con:foz:g to various inta:ntional trade an taiff con.train 

A third factor thAt wold increase the receptivity to this 

opolal i8 a mo:. develope rationle for the fQrm fee ra 

on all lev.l. of the fo04 indu8tr. A8 it 8tands, whol.e8alers 

A ­

will pay most of these fees, since the value of food at the
 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 

pre8ents a no el approach to maaqinq fedsral and .tate food inspection resources. Its viability will depend considerably on 

hew well the final report refines the idea and explores it. feasibility. 

Finally, any attempt to 
 pl8ment user fees for food Lnspections 

needs to be considered in the contest of the comprehensive user 

fa. strategy. The Office of the Secretary has asked PDA to 

develop n a blueprint for haw ast. to dev81cp a ratic1\l mechanism 

fer achieving Conqrese1onal, induat2:, aqe01, and public

consensus on the .. li.hment of u.. f.... The inormation on food 1nspeetionl develope 1ft the final version of ths OIG 

report will be considered by PDA in it. preparation of the 

blueprint fer user f.... 

'IECHRICA COJO6. 

Paae 1. oaraqraph t.ast sent8nce: Mayonnise and many other hiqh risk tOOQ8 do DQ present a botulism hazard. 

Rather there ue other problem t:8" may cause, such 

as staphyloccal ent. Qtozin an histame., which ar8 

considered to be high ri.k. 

Paae 2. sent.nce 2: Should read, -The FD relies on its 

h.adquarter. to provide national gudance thuqh its Compliance Pro Guidace Kaual an OD it. 21 district offices to set their ow local priorities. 

Secau.e of ita larqe wcrkloac1 and limted 

resources, FDA must ..tablish prioriti.. for its inspeions, in doinq thi., low-risk food .afety inspections 

may not necessarily have the sam importance .a .CD other inspetions. 

to 

, 1 iJ--:::a ha: O:a ::c1er norml in8pection pJcedur8., tha't ri;ht: ha be questioned becaus8 the statute is not ezlic on ths poin 

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paae 13. last caraaraoh, sentence No national
 reqirements e%ist , because no means of obtaLninq
 consistency from State to State has been fully successful. 

6 .	 paae 15. ;ootnote: 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. 

aae 22, paragracU. sentence To ru such 1m expanded

laboratory operation davoted to low-risk food., FDA would need add! tional FTs and money from Conqres8. 

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:J Ii ' 

DIPAaTMINT O' HEALTH. HUMA SUVICD 

41O,. Q,C. 2D' 

MA 

TO) Richard P. xu.erov 

In.pactor Gearal 

FROM: Aa. istant Secretary tor planinq and !Valuation 

StJBJECT : OIa Draft Report: -FD roo Safety In.paction, 

011-05-90-01070 

I have reviewed the 01e; Drtt Report, 8Pn roo Safety 

In.paction, 8 and I concu with the t1rat four rec08andation. 

the report. The cU..ini.hin9 priority ba. placed on 

in.paction of low ri.k too tira coupled vith their 118it84 

authority to acce.. fira record baa reslt8c 1f an 1feffici.nt 

.yat.. of foo .afety inpaction tht reqire. FD to .upplament autea to conduct the it. effort. by contractin9 vith 36
 inapeiona. The rec08andation. for a un1fora .y.t.. 80ni tor.4 

by FD with certification of .Ute. to conduct 1npac:1ona woulc! 

ell8inate cuant 1feffic1ancie8 an r..ult 1f 80re frequent 

1f.pactiona of all fir.. 

ion of ua.r wi th r8Card to the fifth r808endation, the coll


f.e., tbe propo.al to collec $513 a111ion anually 1n user t...


to tu the creation of a unifom 818t- a. vell .. 1napction 

activit1e. i. unjuatifi84 an ..y be exce..1ve. In 1... total 

rnA fu1n for all foo aafety activiti.. va. only $132 .illion. 

enanc..anU voulel ni.. the co.t of It i. unclear vby p
 the C\ant Z'ua (t132 a1l110n) al80. fou-fold ($513

.illion). I caoi conc vith I'08Pen dation five vithout 

exlantion an jU8 1fioation for the 112: fM exnditure.. 

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DEPARTMENT OF HEALTH. HUMAN SUVICts 0f of th S8lQy 

Wanl ton, O. C. 20201 AP 1 6 1991 

KDORAOX ch d
 us.erow I s eneral 

nOM it E. ley As. i.tan 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 .illion per year) 

which the report recommend. FDA collect is far larer than the point out that the amount ot 

level of resource. curently devoted to foo .afety. The $513 million fique i. 160' larger than FDA t . planed FY 1992 u.er fee

collection. from all reglated indu.trie., 304' larger than the


FY 1992 amount budgeted for the field operation. of the Center


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


1992 budget. Since the Report doe. not present information that
 there are ujor .atety probl- in the food industr, we think 

that the idea of collecting .0 .uch more trom the tood industry 

than i. cuently being spent on too .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 

million could repre.ent .everal y.ar. of f.. collection 

be raised from user t... 

With re.pect to the oth.r recomendation., we aqree tha 

reqi.tration of food tir .hould be undatory (recommendation 1) 

and that .tat.. .hould bein to tae 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 

the idea ot PD developinq specific .tandards for low risk food 

inspection. (recomm.ndation 2) we are concered that cost of 

developinq such .tandard. aiqht not be ju.titied by the 

hi.torically low ri.k po.ed by th.se indu.trie.. 

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, 

,

APPENDIX 

OFFCE OF INSPECfR GEN REPONSE TO AGENCY COMM 
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 

consistency in inspections. Eight of the 10 States supported the user fee concept to 

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. 

Our view is that the user fee suggested could replace much of the State fudig 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. 

We expect that the intial costs of starg a national program that encompasses a 

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 

increased laboratory testig wi be 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. 

OIG REPONSE TO ASPE COMM 

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 lowrisk 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 

fund the registry of fis, 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.