FDA Regulation: Compliance by Dietary Supplement and Conventional Food
Establishments (Letter Report, 06/13/94, GAO/HEHS-94-134).
The Food and Drug Administration (FDA) regulates dietary supplements,
which include vitamins, proteins, herbs, and fish oils, on a
case-by-case basis, generally responding to complaints or other
information on health risks. It takes action only when it is concerned
about a product's safety or labeling. The frequency of inspections at
dietary supplement establishments is somewhat less when compared with
conventional food establishments. FDA takes official enforcement actions
against dietary supplement establishments almost twice as often because
FDA finds that they violate the regulations more often. FDA does not
maintain data on the costs that dietary supplement establishments incur
to comply with FDA regulations. However, limited cost data provided to
GAO from dietary supplement establishments show that such establishments
incur a wide range of costs. Finally, GAO found that the resources FDA
uses to regulate the dietary supplement industry represent a small
percentage of its total workforce.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: HEHS-94-134
TITLE: FDA Regulation: Compliance by Dietary Supplement and
Conventional Food Establishments
DATE: 06/13/94
SUBJECT: Nutrition research
Safety regulation
Product safety
Labeling law
Public health legislation
Food industry
Investigations by federal agencies
Law enforcement
Compliance
Consumer protection
**************************************************************************
* This file contains an ASCII representation of the text of a GAO *
* report. Delineations within the text indicating chapter titles, *
* headings, and bullets are preserved. Major divisions and subdivisions *
* of the text, such as Chapters, Sections, and Appendixes, are *
* identified by double and single lines. The numbers on the right end *
* of these lines indicate the position of each of the subsections in the *
* document outline. These numbers do NOT correspond with the page *
* numbers of the printed product. *
* *
* No attempt has been made to display graphic images, although figure *
* captions are reproduced. Tables are included, but may not resemble *
* those in the printed version. *
* *
* A printed copy of this report may be obtained from the GAO Document *
* Distribution Facility by calling (202) 512-6000, by faxing your *
* request to (301) 258-4066, or by writing to P.O. Box 6015, *
* Gaithersburg, MD 20884-6015. We are unable to accept electronic orders *
* for printed documents at this time. *
**************************************************************************
Cover
================================================================ COVER
Report to Congressional Committees
June 1994
FDA REGULATION - COMPLIANCE BY
DIETARY SUPPLEMENT AND
CONVENTIONAL FOOD ESTABLISHMENTS
GAO/HEHS-94-134
FDA Regulation
Abbreviations
=============================================================== ABBREV
BCO - black currant oil
FDA - Food and Drug Administration
OEI - Official Establishment Inventory
Letter
=============================================================== LETTER
B-252966
June 13, 1994
The Honorable Edward M. Kennedy
Chairman, Committee on Labor and
Human Resources
United States Senate
The Honorable Nancy L. Kassebaum
Ranking Minority Member, Committee on
Labor and Human Resources
United States Senate
The Honorable John D. Dingell
Chairman, Committee on Energy and Commerce
House of Representatives
The Honorable Carlos J. Moorhead
Ranking Minority Member, Committee on
Energy and Commerce
House of Representatives
The dietary supplement industry has made claims of regulatory bias in
the Food and Drug Administration's (FDA) treatment of dietary
supplements and the public has expressed concern that FDA's actions
could deprive consumers of many dietary supplements or require
prescriptions for some of them. As a result, the Congress directed
GAO through the Dietary Supplement Act of 1992 to study FDA's
management activities related to dietary supplements. We submitted
an interim report to the appropriate committees on July 2, 1993
(GAO/HRD-93-28R), which provided preliminary information on FDA's
oversight of the dietary supplement industry.
Because FDA has not undertaken a program to assess risk and does not
have data on manufacturers' costs, we agreed with your respective
offices in our final report to provide an overview of FDA's
regulation of dietary supplements and a comparison of FDA's
compliance activities of dietary supplement establishments and
conventional food establishments. Also, to the extent that
manufacturers could provide us their costs to comply with regulatory
requirements, this would be reported.
We conducted our study at two FDA district offices, Denver and Los
Angeles, because these offices had a high concentration of dietary
supplement establishments. These districts cover FDA work in
southern California, Colorado, Nevada, New Mexico, Utah, and Wyoming.
Because FDA's information system could not readily or accurately
identify all activities related to dietary supplements, we limited
our review to these two districts and conducted a manual review and
analysis of files and computer data for 3 fiscal years, 1990 through
1992. FDA provided information on the amount of resources expended
on compliance activities. We visited several dietary supplement
manufacturers to obtain cost data.
We conducted our study from September 1993 to March 1994 in
accordance with generally accepted government auditing standards.
We obtained written comments from FDA. FDA found our report
generally to be fair and accurate. Where appropriate, we have made
suggested changes to further clarify the information presented.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
FDA regulates dietary supplements on a case-by-case basis, generally
responding to complaints or other information regarding health risks,
and takes action only when it has a concern about a product's safety
or labeling. The frequency of inspections at dietary supplement
establishments is somewhat less when compared with conventional food
establishments. FDA takes official enforcement actions against
dietary supplement establishments almost twice as often because FDA
finds them to be in violation of the regulations more frequently.
FDA does not maintain data on the costs that dietary supplement
establishments incur to comply with FDA regulations. However,
limited cost data provided to us from dietary supplement
establishments show that such establishments incur a wide range of
costs. Finally, we found that the resources FDA uses to regulate the
dietary supplement industry represent a small percentage of its total
work force.
BACKGROUND
------------------------------------------------------------ Letter :2
FDA considers dietary supplements to be tablets, capsules, powders,
or liquids of vitamins and essential minerals; proteins; herbs,
including botanicals such as ginseng and yohimbe; fish oils; oil of
evening primrose; fibers such as psyllium; compounds not generally
recognized as foods or nutrients such as bioflavonoids, enzymes,
germanium, nucleic acids, para-amino-benzoic acid and rutin; and
mixtures of these ingredients. An estimated 35 to 60 percent of the
population uses dietary supplements daily or occasionally, and up to
60 million users take supplements daily.
Dietary supplements may be foods, food additives (a subcategory of
foods), or drugs. Many of the substances used in dietary supplements
fall within the food definition because they are used for taste,
aroma, or nutritional value. Foods do not require FDA premarket
approval.\1
However, food additives require such premarket approval unless they
are generally recognized as safe. Dietary supplements that make drug
claims are subject to drug regulations. Drug products require
premarket approval and must be shown to be safe and effective before
they can be marketed.
FDA considers dietary supplements that are added to food products to
be subject to regulation as food additives and, thus, subject to
premarket approval unless they are generally regarded as safe. The
dietary supplement industry would like dietary supplements to be
regulated as foods, not as food additives, because foods do not
require premarket approval by FDA.
FDA considers moderately potent vitamin and mineral dosages to be
generally safe. FDA is concerned that other substances, such as
amino acids, herbals, botanical oils, and some megadosages of
vitamins and minerals could pose a health risk.\2
The Dietary Supplement Act placed about a 1-year moratorium on
implementing the provisions of the Nutrition Labeling and Education
Act of 1990 with respect to dietary supplements that were not in the
form of conventional foods such as breakfast cereals.\3 The
moratorium was enacted so that consideration could be given by FDA
and other principals to the best way to regulate dietary supplements.
The moratorium expired in December 1993 and FDA issued final
regulations in January 1994. The regulations will be fully
implemented by July 1995. Under the regulations, supplement labels
will have to provide the same kinds of information as that required
for conventional foods. The regulations will permit health claims on
supplement labels if FDA finds significant agreement among qualified
experts that these claims are scientifically valid. The health
claims regulation goes into effect on July 5, 1994.
--------------------
\1 Foods are regulated under the Federal Food, Drug and Cosmetic Act
to protect the public from products that may be deleterious, unclean
or decomposed, exposed to unsanitary conditions, or contaminated with
filth. FDA performs inspections of food establishments to assure
that good manufacturing and storage practices are followed to prevent
these conditions.
\2 A serious case of this was L-tryptophan, an amino acid, that was
removed from the market in 1989 after it was responsible for about
1,500 illnesses and at least 38 deaths. An FDA official advised us
that most illnesses attributed to L-tryptophan were not reported to
the Centers for Disease Control and Prevention. She said that
between 5,000 and 10,000 people likely became seriously ill from
products containing L-tryptophan. L-tryptophan was sold, for the
most part, without any drug claims on its label, but was often used
to treat insomnia or depression.
\3 Without the moratorium, the act would have required FDA to issue
nutrition and health claim labeling regulations by November 1992.
FDA REGULATES DIETARY
SUPPLEMENTS ON A CASE-BY-CASE
BASIS
------------------------------------------------------------ Letter :3
FDA's objective for regulating dietary supplements is to ensure that
they are safe and that their labeling claims are truthful and not
misleading. FDA regulates dietary supplements on a case-by-case
basis as food, drugs, or both, depending on their intended use and
claims.
FDA's Commissioner stated in a 1992 internal memorandum that FDA will
not take action against a dietary supplement manufacturer that does
not comply with the legal requirements for a food additive unless it
has a concern about safety or mislabeling. FDA officials said that
the agency has not systematically regulated these products (for
example, as it does for drugs, medical devices, and foods, where FDA
routinely schedules inspections) since the 1976 enactment of the
Proxmire amendment.\4
The Proxmire amendment restricts FDA from establishing limits on the
potency of vitamins and minerals unless safety is a concern. The
amendment also prohibits classifying vitamins and minerals as drugs
because they are more potent than FDA considers to be nutritionally
rational or useful. FDA officials said that this amendment and
actions taken by the courts relative to cases on other dietary
supplements dissuaded the agency from routinely regulating these
products.\5 As a result, according to FDA officials, FDA's current
approach to regulating dietary supplements in general is contrary to
its basic principles of trying to prevent harm rather than reacting
to a condition after some harm, physical or economic, has occurred.
FDA officials told us that FDA evaluates the health risks of dietary
supplements on a case-by-case basis, responding to complaints or
other information brought to FDA concerning a product's safety or
labeling. Manufacturers do not submit data to FDA to evaluate the
safety of such products before marketing; rather the manufacturers
make a determination that their products are generally recognized as
safe. FDA does not schedule, as part of its overall work program,
inspections for dietary supplement establishments. Compliance
inspections are performed when FDA receives complaints or other
information concerning a specific product's safety or labeling.
However, FDA district offices can schedule inspections of dietary
supplement establishments as part of their internal work plans.
Concerned over several incidents of adverse reactions attributable to
dietary supplements, FDA took actions to improve its monitoring of
these products. In 1992 FDA created the Office of Special
Nutritionals within the Center for Food Safety and Applied Nutrition
to collect and evaluate reported adverse effects from dietary
supplements. Also, in June 1993 FDA specifically included dietary
supplements in its instructions to health professionals for reporting
adverse effects through its voluntary MedWatch program.
--------------------
\4 Section 501 of the Health Research and Health Services Amendments
of 1976 (P.L. 94-278).
\5 For example, FDA sought to condemn 29 cartons of encapsulated
black currant oil (BCO) contending that it was an unapproved food
additive of questionable safety, U.S. v. 29 Cartons of *** An
Article of Food, 987 F.2d 33 (1st Cir. 1993). FDA argued that the
BCO, contained in capsules made from gelatin and glycerin (inert
substances), could be regulated as a food additive. A federal
district court disagreed, holding that the BCO had no effect on the
capsules themselves and could not be considered a food additive. The
court held that BCO was a food, in which case it is presumed to be
safe unless FDA could show otherwise. The appellate court upheld the
lower court's decision to dismiss FDA's complaint and its order to
release the BCO.
DIETARY SUPPLEMENT
ESTABLISHMENT INSPECTIONS NOT
EMPHASIZED
------------------------------------------------------------ Letter :4
The percentage of firms inspected by FDA and the extent of repeat
inspections did not vary greatly between dietary supplement
establishments and conventional food establishments. The number of
dietary supplement and conventional food establishments inspected by
FDA's Denver and Los Angeles district offices during fiscal years
1990, 1991, and 1992 averaged 12.8 percent and 15.9 percent,
respectively, as a percentage of the establishments listed on the
Official Establishment Inventory (OEI).\6 FDA's Denver district
office performed a greater percentage of inspections of dietary
supplement establishments than conventional food establishments.
Conversely, the Los Angeles district office performed a greater
percentage of inspections of conventional food establishments than
dietary supplement establishments. (Table I.1 in appendix I shows
the number of inspections in the Denver and Los Angeles districts for
fiscal years 1990-92.)
We found that frequencies of repeat inspections during fiscal years
1990-92 were relatively close. At FDA's Denver district, of the 34
dietary supplement establishments that were inspected during the
3-year period, 9, or about 26 percent, were inspected more than once.
Of the 389 conventional food establishments inspected during the same
period, 87, or 22 percent, were inspected more than once. From 1990
through 1992, FDA's Los Angeles district office inspected 106 dietary
supplement establishments, and 18, or 17 percent, were inspected more
than once. Of the 943 conventional food establishments inspected by
FDA's Los Angeles staff, 214, or 23 percent, were inspected more than
once. (Table I.2 in appendix I compares the number of multiple
inspections performed in the Denver and Los Angeles districts for
fiscal years 1990-92.)
About 73 percent of the inspections at dietary supplement
establishments took place at manufacturers, packers, repackers, and
distributors. Retailers accounted for about 9 percent of the
inspections; warehouses represented 12 percent; and the remainder,
about 6 percent, included corporate headquarters and laboratories.
FDA did not perform an analysis to determine the reasons that
inspections were conducted at dietary supplement establishments. At
the Denver and Los Angeles offices, we reviewed files for cases where
regulatory actions were recommended by these districts. We found
that 54 percent of the inspections were initiated by complaints. The
remaining 46 percent were initial or reinspections scheduled by the
districts as part of their routine compliance work. Complaints from
consumers were 52 percent of all complaints. Complaints from
competitors were another 21 percent, and the remaining 27 percent of
complaints came from other government entities such as the Federal
Trade Commission and a state food and drug department.
--------------------
\6 The Official Establishment Inventory (OEI) is a computerized
database of firms maintained by the FDA Office of Regulatory Affairs.
This inventory includes among other things for each firm (1) the name
and address of the firm, (2) appropriate establishment information
and industry codes, (3) information on whether the firm has gone out
of business, (4) the last inspection date, (5) the last violative
inspection date, and (6) the size of the firm.
ENFORCEMENT ACTIONS TAKEN MORE
FREQUENTLY AGAINST DIETARY
SUPPLEMENT ESTABLISHMENTS
------------------------------------------------------------ Letter :5
Compliance inspections performed by FDA district offices at
conventional food and dietary supplement establishments have resulted
in reports concluding that (1) no violations were found and no
actions were needed, (2) violations were found of varying degrees and
the establishments could take voluntary action to correct the
objectionable conditions, or (3) violations were found that should
result in an official regulatory action. An official action can
constitute a warning letter, recall, seizure/detention, or other
sanctions. Generally, recommendations that involve official actions
for dietary supplements and labeling issues are forwarded by the
districts to FDA headquarters for a decision.
Our data show that a higher percentage of official actions were
recommended for dietary supplement establishments than conventional
food establishments. Over fiscal years 1990-92, investigators
recommended official actions for 0.4 percent and 3.5 percent of the
conventional food establishments inspected in the Denver and Los
Angeles districts, respectively. By contrast, during the same period
investigators believed that official actions were needed for 29.6
percent and 26.8 percent of the dietary supplement establishments
inspected in the Denver and Los Angeles districts, respectively.
Investigators were twice as likely to report voluntary actions for
conventional food establishments compared with dietary supplement
establishments. (Table I.3 in appendix I shows the results of
inspections in the Denver and Los Angeles districts for fiscal years
1990-92.)
FDA officials told us that no analysis has been made to explain why
there is higher incidence of reporting or recommending official
actions for dietary supplement establishments than conventional food
establishments. An FDA headquarters official suggested that
inspections at conventional food establishments, which are normally
routine and scheduled as part of FDA's work plans, are related
primarily to sanitation. Problems are more clearly identified and
communicated at the time of the inspection. For example,
conventional food establishments are either clean and rodent free or
they are not, and operators of conventional food establishments can
readily see what actions are necessary to come into compliance, thus
avoiding the need for official actions. Conventional food
establishments, according to the official, are more familiar with
FDA's inspection procedures and the actions needed to correct the
condition.
On the other hand, inspections at dietary supplement establishments
often focus on product literature and labels that make health-related
claims. An FDA headquarters official stated that when dietary
supplement establishments disagree with FDA about health-related
claims, which are more subjective than sanitary conditions, and do
not take corrective action, FDA frequently recommends an official
action. Moreover, inspections at dietary supplement establishments
often stem from complaints, headquarters health fraud bulletins or
other concerns, or previous FDA work, indicating that a problem and a
potential violation already exist.
COSTS OF COMPLIANCE VARY WITH
INDUSTRY
------------------------------------------------------------ Letter :6
FDA does not have data showing the costs that dietary supplement
establishments incurred to comply with FDA regulations. However,
limited cost data provided to us from manufacturers show that dietary
supplement establishments incurred a wide range of costs. These
costs most frequently represented expenditures for legal and
consulting fees and product relabeling, but also included quality
control measures, laboratory analyses, and, in some instances, the
value of seized products. In commenting on this report, FDA stated
that the types of compliance costs cited by dietary supplement
establishments are common to regulated industry.
We visited nine dietary supplement establishments, primarily
manufacturers, and requested financial data to show the costs that
they incurred. Of these nine establishments, eight provided us with
financial information. The median average amount expended to meet
regulatory requirements for these establishments was $47,050. These
costs ranged from $1,400 for one small establishment to $850,000 for
a large establishment. Although we did not verify this cost data,
almost all these establishments had been the subject of some type of
enforcement action. Therefore, portions of their reported costs were
to correct FDA-cited problems. In addition, establishments
legitimately incur costs as part of their normal business practices
to maintain quality standards, just as any food or drug manufacturer
is required to do by FDA.
To illustrate the kinds of costs incurred, one small manufacturer
spent $1,400 to delete health claims from its labels and to install
storage shelves to meet sanitation requirements. Of the eight firms,
seven indicated that they had incurred legal fees. The average legal
fee was $17,700. The range of legal fees was from $4,100 to
$185,000, and often represented the costs for outside counsel and
advice on labeling or product literature to prevent or correct
problems. In two instances, establishments cited the costs of
products seized by FDA, amounting to $15,000 at one establishment and
$457,000 at the other.
Officials at several of the establishments we visited said that they
make expenditures to avoid FDA enforcement actions by making certain
that their products are marketed in accordance with FDA requirements.
For example, one establishment showed that it spent almost $500,000
for quality control measures and equipment to ensure that it met good
manufacturing practices.
LIMITED AMOUNT OF RESOURCES
EXPENDED ON DIETARY SUPPLEMENTS
------------------------------------------------------------ Letter :7
As measured by its total workforce used to regulate all products, FDA
does not expend a significant amount of its resources on its dietary
supplement compliance activities. Our interim report stated that FDA
estimated that about 20 full-time-equivalent employees per year
between fiscal years 1988 and 1992 were used to regulate dietary
supplements. This was less than 1 percent of the total 3,400
full-time-equivalent employees that were involved in regulating all
products under FDA's jurisdiction. Since our interim report and at
our request, FDA reassessed the amount of resources that were used in
its compliance activities for dietary supplements. Due to
limitations in its information system, FDA had to do a manual and
time-consuming review of the data, and provided information for only
fiscal year 1992. FDA now estimates that 79 full-time-equivalent
employees were used to regulate dietary supplements. This represents
about 2.3 percent of its 3,400 full-time-equivalent employees used to
regulate all products.
FDA understated its resources used in regulating dietary supplements
at about 20 full-time-equivalent employees because not all dietary
supplement products were identified under the same industry code.
FDA found, for example, that investigators used other industry codes,
such as the code for human drugs, if products made health-related
claims. Beginning in fiscal year 1994, FDA consolidated all dietary
supplement actions under one code. This consolidation should allow
FDA to identify the resources used to regulate dietary supplement
establishments.
---------------------------------------------------------- Letter :7.1
If you or your staff would like to discuss any of the issues in this
report, please contact me at (202) 512-7119.
Sincerely yours,
Mark V. Nadel
Associate Director, National and
Public Health Issues
FDA INSPECTIONS IN DENVER AND LOS
ANGELES DISTRICTS
=========================================================== Appendix I
Table I.1
Number of Dietary Supplement and
Conventional Food Establishments
Inspected in the Denver and Los Angeles
Districts
(Fiscal Years 1990-92)
Number Percent
Type of Fiscal inspecte of
establishment District year d OEI\a
------------------ ---------- ------ -------- ----------
Dietary supplement Denver 1990 9 13.6
1991 14 21.2
1992 18 27.3
Los 1990 42 12.1
Angeles
1991 40 11.5
1992 36 10.4
Both 1990- -- 12.8
districts 92
Conventional food Denver 1990 152 16.5
1991 145 15.7
1992 164 17.7
Los 1990 467 19.6
Angeles
1991 464 19.5
1992 183 7.7
Both 1990- -- 15.9
districts 92
------------------------------------------------------------
\a For computation purposes, we used the November 9, 1992, Official
Establishment Inventory (OEI) of 66 dietary supplement and 924
conventional food establishments in the Denver district, and 347
dietary supplement and 2,384 conventional food establishments in the
Los Angeles district. The computed inspection percentages may be
slightly overstated or understated due to inventory decreases or
increases between fiscal years 1990 and 1992.
Table I.2
Comparison of Dietary Supplement and
Conventional Food Establishments With
Multiple Inspections (Fiscal Years 1990-
92)
Number of Number of Number of
Type of inspection establishmen Percent of establishmen Percent of
establishment s ts OEI ts OEI
---------------- ---------- ------------ ---------- ------------ ----------
Dietary 0 32 48.5 241 69.4
supplement
1 25 37.9 88 25.4
2 8 12.1 15 4.3
3 1 1.5 3 0.9
4 0 0 0 0
5 0 0 0 0
6 0 0 0 0
Conventional 0 535 57.9 1,441 60.4
food
1 302 32.7 729 30.6
2 74 8.0 163 6.8
3 9 1.0 32 1.3
4 3 0.3 12 0.5
5 0 0 2 0.1
6 1 0.1 5 0.2
--------------------------------------------------------------------------------
Table I.3
Results of Inspections in the Denver and
Los Angeles Districts (Fiscal Years
1990-92)
Number of Official Voluntary
Fiscal inspection action action No action
Type of establishment District year s indicated\a Percent indicated\b Percent indicated\c Percent Other\d Percent
-------------------------- -------- -------- ---------- ----------- -------- ------------ -------- ------------ -------- -------- --------
Dietary supplement Denver 1990 9 1 11.1 2 22.2 5 55.6 1 11.1
1991 15 6 40.0 5 33.3 4 26.7 0 0
1992 20 6 30.0 4 20.0 8 40.0 2 10.0
=====================================================================================================================================================
Total 1990-92 44 13 29.6 11 25.0 17 38.6 3 6.8
Los 1990 44 5 11.4 15 34.1 22 50.0 2 4.5
Angeles
1991 45 14 31.1 10 22.2 19 42.2 2 4.4
1992 38 15 39.5 11 28.9 12 31.6 0 0
=====================================================================================================================================================
Total 1990-92 127 34 26.8 36 28.3 53 41.7 4 3.1
Conventional foods Denver 1990 168 2 1.2 79 47.0 86 51.2 1 0.6
1991 157 0 0 63 40.1 93 59.2 1 0.6
1992 170 0 0 87 51.2 83 48.8 0 0
=====================================================================================================================================================
Total 1990-92 495 2 0.4 229 46.3 262 52.9 2 0.4
Los 1990 543 17 3.1 332 61.1 183 33.7 11 2.0
Angeles
1991 509 20 3.9 296 58.2 185 36.3 8 1.6
1992 193 7 3.6 115 59.6 66 34.2 5 2.6
=====================================================================================================================================================
Total 1990-92 1,245 44 3.5 743 59.7 434 34.9 24 1.9
-----------------------------------------------------------------------------------------------------------------------------------------------------
\a Official Action Indicated represents recommendations to initiate
actions such as recalls, regulatory letters, seizures, or other
sanctions.
\b Voluntary Action Indicated represents recommendations to the
establishment that objectionable conditions be corrected, but do not
justify official action at this time.
\c No Action Indicated represents no objectionable conditions were
found which warrant action by FDA or the establishment.
\d Other includes no recommendations, pending recommendations, or
referrals to states for action.
MAJOR CONTRIBUTORS TO THIS REPORT
========================================================== Appendix II
Sarah F. Jaggar, Director, Health Financing and Policy Issues
Robert F. Hughes, Assistant Director, (202) 512-7203
Albert B. Jojokian, Assistant Director (retired)
Darrell J. Rasmussen, Evaluator-in-Charge
David W. Bieritz
Jean N. Chase
Marie E. DeCocker
Benjamin F. Herr (retired)
Robert J. Wychulis